Moulded cast compared with K-wire fixation after manipulation of an acute dorsally displaced distal radius fracture: the DRAFFT 2 RCT

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 15/27/01. The contractual start date was in July 2016. The draft report began editorial review in September 2020 and was accepted for publication in April 2021. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Copyright statement

Copyright © 2022 Costa et al. This work was produced by Costa et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.

2022 Costa et al.

Background

Fractures of the distal radius are extremely common injuries. In the developed world, 6% of women will have sustained such a fracture by the age of 80 years and 9% will have done so by the age of 90 years. 1 As the population continues to age, these figures are likely to increase. There is a bimodal distribution in terms of age. Younger patients frequently sustain complicated, high-energy injuries involving the wrist joint; however, fractures of the distal radius are also common in older patients, who are more likely to sustain low-energy fractures related to osteoporosis. 2 The optimal management of fractures of the distal radius in adults remains controversial. This study was designed to address both groups of patients, as the key management decisions pertain to all patients with a fracture of the distal radius.

In general, if the bone fragments are undisplaced, that is the bone fragments remain in anatomical alignment, fractures of the distal radius are treated non-operatively. However, if the bone fragments have moved out of their normal alignment, the treating clinician will usually recommend a ‘manipulation’ of the bone fragments to restore the normal anatomy. Manipulating a fracture is painful and, therefore, is carried out using local, regional or general anaesthetic.

Following the manipulation, the bone fragments can fall back out of normal alignment. Therefore, the treating clinician will apply support to the bone fragments while they heal.

This trial compared two techniques for holding the position of the bone fragments following a manipulation of a dorsally displaced fracture of the distal radius: a moulded cast and surgical fixation with Kirschner wires (K-wires).

Relevance of project

Handoll and Madhok3 summarised the results of a series of Cochrane reviews of randomised controlled trials (RCTs) of the treatment of fractures of the distal radius and ‘exposed the serious deficiency in the available evidence’. Furthermore, they were able to identify key areas for future research, including ‘when and what type of surgery is indicated’. 3 In 2014, we published the results of the Distal Radius Acute Fracture Fixation Trial (DRAFFT) [National Institute for Health Research (NIHR) Health Technology Assessment 08/116/974]. 5 In that study, we randomly assigned 461 adult patients undergoing surgery for a dorsally displaced fracture of the distal radius to either a K-wire fixation group or a locking plate fixation group. Contrary to the existing literature, and against the increasing use of plate fixation, the DRAFFT study found that, if a closed reduction of the fracture is possible, then there is no difference in outcomes between the use of K-wires and locking plates for patients with fractures of the distal radius. K-wire fixation is less expensive and quicker to perform than locking plate fixation. This evidence led to a change in clinical practice in the UK6 and changes to national guidelines on the management of this injury. 7

However, there remained unanswered questions, specifically ‘Is there any need to perform surgical fixation of the fracture following a closed reduction of the distal radius, or is a simple cast as effective as the insertion of metalwork?’.

In 2020, Karantana et al. 8 published the results of a Cochrane review of percutaneous wire fixation compared with plater cast use for adult patients with a dorsally displaced fracture of the distal radius. This review included a total of 11 randomised or quasi-randomised trials of manipulation and plaster cast compared with manipulation and K-wire fixation, involving 917, mostly older, participants. Unfortunately, the authors concluded that the quality of the existing evidence was very low. All of the trials included in the review were found to be at a high risk of bias, and allocation concealment was considered adequate in only one trial. Furthermore, all trials reported outcomes incompletely, to the extent that the authors were unable to draw a conclusion with regard to the effect of the interventions on patient-reported function. 8 They did, however, find that the risk of re-displacement of the fracture in participants treated with manipulation and plaster cast was, on average, 12%, (range 3–75%). A review of the published literature8 found no other trials addressing this question since the date of this Cochrane review search (in June 2019).

We conducted a RCT of manipulation and surgical fixation with K-wires compared with manipulation and moulded casting in the treatment of adult patients with a dorsally displaced fracture of the distal radius.

Objectives

The aim of this trial was to improve wrist function and reduce pain by determining the best treatment strategy for adult patients undergoing manipulation for a dorsally displaced fracture of the distal radius.

The primary objective was to quantify and draw inferences on observed differences in the Patient-Rated Wrist Evaluation (PRWE),9 a validated assessment of wrist function and pain, between manipulation and surgical fixation with K-wires and manipulation followed by a moulded cast in the first year post randomisation.

The secondary objectives were to:

1. quantify and draw inferences on differences in the EuroQol-5 Dimensions, five-level version (EQ-5D-5L) [a validated assessment of health-related quality of life (HRQoL)], between surgical fixation with K-wires and moulded casting over the first year post randomisation

2. determine the complication rate, including the need for further surgery, between surgical fixation with K-wires and moulded casting during the first year post randomisation

3. investigate, using appropriate statistical and economic analysis methods, the health-care resource use and comparative cost-effectiveness of surgical fixation with K-wires and moulded casting in the first year post randomisation.

Trial design

The project was designed as a two-phase study. An internal pilot was to be conducted to confirm the expected rate of recruitment in a large-scale multicentre RCT. The main RCT was planned for a minimum of 24 trauma centres.

Participants

Patients were screened in the emergency department or trauma unit of participating trial recruitment centres. Screening logs were kept at each recruitment centre to determine the number of patients assessed for eligibility and reasons for any exclusion. In addition, the number of eligible and recruited patients and the number of patients who declined consent/withdrew were recorded.

Randomisation

Those patients who consented to take part in the trial had their treatment allocated using a secure, centralised, online randomisation service. The randomisation occurred after the manipulation of the fracture, when the surgeon had determined that the fracture could be adequately reduced without the need to open the fracture.

Although the great majority of these injuries were managed on planned trauma operating lists during normal working hours, the randomisation service was open 24 hours each day to facilitate the inclusion of all potentially eligible patients. Randomisation was on a 1 : 1 basis, stratified by recruitment centre, intra-articular extension of the fracture and age of the patient (< 50 or ≥ 50 years). The sequence was generated by the trial statistician based at the Centre for Statistics in Medicine in Oxford.

Stratification by recruitment centre helped to ensure that any clustering effect related to the recruitment centre itself was equally distributed in the trial treatments. Although it was possible that the surgeons at one recruitment centre were more experienced in one or other treatment than those at another centre, all of the recruiting hospitals, and indeed all hospitals throughout the NHS, use both techniques as part of their normal practice so staff and surgeons were already familiar with both forms of treatment. Although this may not eliminate any individual surgeon-specific effect at any one recruitment centre,11 the manipulation of a fracture of the distal radius is a common procedure, so at each recruitment centre many surgeons were involved in the management of this group of patients (between 10 and 30 surgeons, including both consultants and trainees). Therefore, it was anticipated that each surgeon would operate on only a small number of patients enrolled in the trial, thus greatly reducing the risk of surgeon-specific influences affecting the outcome.

Stratification on the basis of intra-articular extension of the fracture addressed a major potential confounder, as disruption of this articular surface of the distal radiocarpal joint may predispose a patient to secondary osteoarthritis of the wrist. 12

Evidence suggests that other associated features of fractures of the distal radius that commonly appear in the classification systems, such as involvement of the ulnar styloid process, do not actually affect the functional outcome of the injury. 13 Therefore, no other fracture variables were included in the stratification of the randomisation.

Stratification on the basis of age was used in an attempt to discriminate between younger patients with normal bone quality sustaining high-energy fractures and older patients with low-energy (fragility) fractures related to osteoporosis. Empirically, both of these groups of patients could benefit, or not, from surgical fixation. However, stratification by age could also help to identify any effect related to the quality of the patients’ bone. The use of dual-energy X-ray absorptiometry is widely regarded as the gold standard for the assessment of bone density. However, this investigation was not routinely available at all recruitment centres. Therefore, we used age as a surrogate for bone density. In a large study in Norway involving 7600 participants,14 it was demonstrated that forearm bone mineral density remains stable up until the age of 50 years. In males, bone mineral density decreases steadily after the age of 50 years, whereas in females there is an initial rapid decline between the ages of 50 and 65 years, with a further decline thereafter. 14 A study by Court-Brown et al. 15 assessed > 1000 patients with a fracture of the distal radius. The study found a clear bimodal distribution according to the age of the patient. The crossover of the two peaks of incidence was around 50 years of age. These studies provide strong evidence that patients aged > 50 years are increasingly vulnerable to fragility fractures of the distal radius. Furthermore, the study by Court-Brown et al. 15 demonstrated that in the UK approximately 60% of patients sustaining a fracture of the distal radius are aged > 50 years, whereas 40% are aged < 50 years. Therefore, we chose age under or over 50 years as the stratification criterion for this trial.

Trial treatments

All participants underwent a closed (i.e. without making any incisions in the skin) manipulation of the fracture. The manipulation was carried out in an operating theatre under either regional or general anaesthetic. The choice of anaesthetic was left to the discretion of the treating surgeon/anaesthetist, as per their normal practice. An X-ray image intensifier machine allowed the surgeon to judge that an adequate closed reduction had been achieved during the manipulation. The decision to accept or not the reduction was left to the discretion of the treating surgeon, as per their normal practice. Only after this decision was made was the participant randomised to one treatment or the other. This trial compared two techniques for holding the position of the bone fragments following the manipulation of a dorsally displaced fracture of the distal radius.

Participant care pathway

Participants were clinically reviewed at around 6 weeks, as per routine practice after this type of injury. The decision on whether or not to record details of additional rehabilitation and follow-up appointments was left to the discretion of the treating clinicians, as per their normal practice.

Primary outcome

The primary outcome measure for this study was the PRWE at 12 months post randomisation. The PRWE is a 15-item questionnaire designed specifically for the assessment of distal radial fractures and wrist injuries and comprises range of questions in two (equally weighted) sections concerning the patient’s experience of pain and function. All questions are scored on an 11-point, ordered, categorical scale ranging from ‘no pain’ or ‘no difficulty’ (0) to ‘worst ever pain’ or ‘unable to do’ (10). Five questions relate to a patient’s experience of pain and 10 questions relate to function and disability; scores for the 10 function items are summed and divided by 2 and added to the total score for the five pain items to give a score out of 100 (best score = 0 and worst score = 100). The PRWE was administered at baseline (at which point wrist function both pre and immediately post injury was assessed) and then again 3, 6 and 12 months post randomisation. Table 1 shows the collection times for all of the trial outcomes. The PRWE is the most sensitive outcome measure available for patients sustaining this specific injury. 16

Secondary outcomes

The secondary outcome measures in this trial were as follows.

Data management: questionnaire completion

Patient-reported outcome data for the 3-, 6- and 12-month outcome points were collected through a questionnaire sent from the trial central office. Those participants who had provided their mobile telephone number and/or e-mail address to the research team received a text message and/or e-mail prior to the first post-out to advise them that they should expect the questionnaire. Reminder text messages and/or e-mails were sent to participants who did not return the questionnaire in a prespecified time frame. Participants who failed to respond to the questionnaire after two attempts were contacted by telephone to minimise the loss of follow-up information.

Participants were offered the option of receiving a £10 gift voucher with their 12-month questionnaire to compensate them for their time.

Adverse event management

Adverse events were listed on the appropriate case report form (CRF) for routine return to the ‘DRAFFT 2’ central office. Serious adverse events (SAEs) were entered onto the SAE reporting form and reported to the central study team. However, some adverse events that were foreseeable as part of the proposed treatment were not reported on a SAE reporting form and were instead recorded on a complication form. These events included complications of anaesthesia or surgery (e.g. wound infection or damage to nerves, tendons or blood vessels), complex regional pain syndrome (CRPS), deep-vein thrombosis (DVT)/pulmonary embolism (PE) and further planned surgery for the removal of symptomatic metalwork or for the loss of fracture position/malunion. All participants experiencing SAEs were followed up as per protocol until the end of the trial.

Statistical analysis

Analysis plan

Health economic analysis plan

A within-trial economic evaluation was conducted from the recommended NHS and Personal Social Services (PSS) perspective in the base-case (primary) analysis. 29

Ethics approval and monitoring

Screening and randomisation

Patient screening for potential study participants was open from January 2017 to March 2019. A total of 2636 patients were screened, of whom 1441 were not eligible because they met one of the exclusion criteria. A further 495 were not included because of the clinician’s treatment preference, and 196 declined to participate in the study (Table 2 shows the reasons for declining consent and Table 3 shows the clinicians’ stated treatment preference). The Consolidated Standards of Reporting Trials (CONSORT) flow diagram shows the reasons for ineligibility (Figure 1).

FIGURE 1.

The CONSORT flow diagram.

A total of 179 patients consented to enter the study but were not randomised because the articular surface of their fracture could not be reduced by indirect techniques during manipulation under anaesthetic in the operating theatre.

A total of 504 patients were entered into the randomisation system, but four were entered in error (without consent). Therefore, this trial randomised a total of 500 participants, of whom 255 were allocated to the cast group and 245 were allocated to the K-wire group.

Recruitment

The first randomisation took place on 31 January 2017 and the final randomisation was on 28 March 2019, and the final 12-month follow-up was received on 18 May 2020.

Baseline characteristics

Treatment information

Information on treatments is presented in Figure 2 and Table 7. Figure 2 is a box plot of procedure duration for each group and shows that fixation with K-wire took longer than moulded casting. Table 7 shows other details about the treatments performed. The majority of treatments (87.1% and 82.4% in the cast and K-wire group, respectively) were performed by experienced surgeons who had performed over 20 procedures for both cast and K-wire interventions. A total of 361 surgeons performed the treatments as part of the trial. The median number of treatments per surgeon was 1, with a range of 1–11.

FIGURE 2.

Box plot of procedure duration time by treatment group.

TABLE 7 - Treatment details by treatment group

N/A, not applicable.

All participants in the K-wire group had a neutralising cast.

Treatment details	Treatment group, n (%)
	Cast (N = 255)	K-wire (N = 245)
Perioperative antibiotic cover used
Yes	48 (19.0)	181 (74.8)
No	204 (81.0)	61 (25.2)
Number of prior patients with a displaced distal radius fracture treated by surgeon
0	1 (0.4)	5 (2.0)
< 5	4 (1.6)	13 (5.3)
5–10	11 (4.3)	7 (2.9)
11–20	17 (6.7)	18 (7.4)
> 20	222 (87.1)	201 (82.4)
K-wire information
Number of wires used
1	0 (0.0)	5 (2.0)
2	4 (1.6)	154 (63.1)
3	7 (2.7)	74 (30.3)
> 3	1 (0.4)	3 (1.2)
N/A	243 (95.3)	8 (3.3)
Wire size (mm)
1.1	0 (0.0)	1 (0.4)
1.6	9 (3.5)	172 (72.6)
Other	3 (1.2)	56 (23.6)
N/A	243 (95.3)	8 (3.4)
Pinning technique used
Interfragmentary	6 (2.4)	91 (38.2)
Kapanji	4 (1.6)	93 (39.1)
Mixed technique	2 (0.8)	46 (19.3)
N/A	243 (95.3)	8 (3.4)
Cast informationa
Thumb included
Yes	59 (23.2)
No	176 (69.3)
N/A	19 (7.5)
Material used
Fibreglass	13 (5.1)
Plaster of Paris	222 (87.1)
Other	1 (0.4)
N/A	19 (7.5)
Coverage
Backslab	19 (7.5)
Full cast	214 (84.9)
N/A	19 (7.5)

Primary outcome

Analysis of primary outcome: Patient-Rated Wrist Evaluation score at 12 months post randomisation

The PRWE score was assessed at baseline (pre and post injury), and at 3, 6 and 12 months post injury. The mean PRWE score and SD for each treatment group at each time point (excluding pre-injury baseline as this did not contribute to the analysis model) are provided in Table 9 and were based on all available data at each time point. The adjusted mean differences in PRWE score were obtained from a linear mixed-effects regression model adjusting for the stratification factors age and articular extension and observations within participants within recruitment centres as random effects. Baseline (post injury) was included as a response, rather than adjusted for as continuous covariate fixed effect, to obtain time point-specific estimates for baseline to be used in the AUC analysis. The number of observations for each treatment group is the number of participants who supplied PRWE data at that time point. The analysis was performed on the prespecified ITT population defined in Chapter 2, Definition of analysis populations. The adjusted analysis was prespecified as the primary trial results.

TABLE 9 - Patient-reported wrist evaluation scores (primary outcome)

Model estimate.

Time point	Treatment group				Mean difference		p-value
	Cast		K-wire
	n	Mean (SD)	n	Mean (SD)	Unadjusted	Adjusted (95% CI)
Baseline (post injury)	253	84.3 (13.30)	243	81.91 (14.52)	–2.39
3 months	213	42.08 (23.85)	201	41.56 (24.77)	–0.51	–0.45 (–4.37 to 3.47)	0.82
6 months	202	28.35 (23.35)	206	27.56 (22.33)	–0.79	–0.32 (–4.26 to 3.62)	0.87
12 months (primary outcome)	200	21.16 (23.09)	195	20.69 (22.33)	–0.47	–0.34 (–4.33 to 3.66)	0.87
AUC over 12 months		38.19a		37.60a		–0.60 (–4.41 to 3.21)	0.88

The adjusted results in Table 9 show no significant treatment effect at any of the time points or in the AUC analysis. The primary outcome (i.e. PRWE score at 1 year) shows a between-group difference of –0.34 (95% CI –4.33 to 3.66; p = 0.87). Figure 3 shows the means and SDs at each time point used in the analysis model (baseline post injury and 3, 6 and 12 months post randomisation). Figure 4 shows the density plot of the 12-month PRWE score for both the cast and the K-wire groups.

FIGURE 3.

Change in PRWE score by treatment group over time.

FIGURE 4.

Histograms of PRWE score at 12 months post randomisation by treatment group. (a) Cast group and (b) K-wire group.

Graphical model checks were performed as part of the analysis and indicated no issues with the model fit as well as no evidence of the underlying assumptions not being met. These checks are available on the project webpage (www.journalslibrary.nihr.ac.uk/programmes/hta/152701/#/; accessed October 2021) .

Secondary outcomes

EuroQol-5 Dimensions, five-level version, index

The secondary outcomes (i.e. EQ-5D-5L index at 3, 6 and 12 months post randomisation, as well as the EQ-5D-5L index AUC) are presented in Table 10. A mixed-effects model, as used in the primary outcome, was used to assess these outcomes. The means and SDs are presented, as well as adjusted mean differences, 95% CIs and p-values derived from the model. A graphical summary of the EQ-5D-5L index means and SDs for each time point by treatment group is shown in Figure 5. The EQ-5D-5L index showed improvement over time from injury until 12 months post randomisation, but there was no significant treatment effect at any time point or AUC analysis with a 12-month adjusted mean difference of –0.03 (95% CI –0.07 to 0.02). The distribution of the five domains is presented in Appendix 2, Figures 17–21.

TABLE 10 - The EQ-5D-5L index results

Model estimate.

Time point	Treatment group				Mean difference		p-value
	Cast		K-wire
	n	Mean (SD)	n	Mean (SD)	Unadjusted	Adjusted (95% CI)
Baseline (post injury)	252	0.35 (0.28)	241	0.37 (0.26)	0.02
3 months	217	0.68 (0.21)	203	0.67 (0.20)	–0.01	–0.02 (–0.06 to 0.02)	0.37
6 months	204	0.75 (0.21)	207	0.75 (0.18)	0.00	0.00 (–0.04 to 0.04)	0.96
12 months	199	0.81 (0.20)	197	0.78 (0.21)	–0.02	–0.03 (–0.07 to 0.02)	0.26
AUC over 12 months		0.69a		0.68a		–0.01 (–0.05 to 0.03)	0.82

FIGURE 5.

Change in EQ-5D-5L index by treatment group over time.

EuroQol-5 Dimensions visual analogue scale

The secondary outcome EQ-VAS, a QoL score running from 0 to 100 with higher values indicating better QoL, at 3, 6 and 12 months post randomisation, and the EQ-VAS AUC scores are presented in Table 11. A linear mixed-effects model, as used in the primary outcome, was used to assess these outcomes. The means and SDs are given along with adjusted mean differences, 95% CIs and p-values derived from the model. A plot of the EQ-5D VAS means and SDs on all available data for each time point by treatment group is given in Figure 6. The EQ-5D VAS showed improvement over time but there was no significant treatment effect at any time point or AUC analysis with a 12-month adjusted mean difference of –0.51 (95% CI –4.30 to 3.29; p = 0.79). This result is supported by Figure 6, indicating no raw mean difference at any time.

TABLE 11 - The EQ-5D VAS results

Model estimate.

Time point	Treatment group				Mean difference		p-value
	Cast		K-wire
	n	Mean (SD)	n	Mean (SD)	Unadjusted	Adjusted (95% CI)
Baseline (post injury)	253	63.87 (22.76)	242	64.19 (23.14)	0.32
3 months	216	77.08 (18.25)	201	75.55 (18.51)	–1.53	–1.73 (–5.44 to 1.98)	0.36
6 months	202	79.29 (20.02)	204	81.09 (16.37)	1.80	1.87 (–1.88 to 5.61)	0.33
12 months	199	81.11 (18.06)	195	80.42 (18.00)	–0.69	–0.51 (–4.30 to 3.29)	0.79
AUC over 12 months		76.81a		76.98a		0.16 (–3.59 to 3.92)	0.97

FIGURE 6.

Change in EQ-5D VAS by treatment group over time.

Missing data

The primary analysis was performed using a complete-case analysis, which assumed the data were MAR (i.e. the unobserved data were from the same conditional distribution as the observed data.) This seemed to be a plausible assumption for this trial as the number of patients lost to follow-up was low and there were roughly equal numbers of missing data across both treatment groups. However, two sensitivity analyses on missing data were performed.

The first sensitivity analysis used imputation of quantiles. For each missing data point, the median value of the treatment group was imputed and analysed using the same mixed model as in the primary analysis. The analysis was repeated on a population that had the 60th quantile imputed for one group’s missing values and the 40th quantile for the other, then again using the 70th and 30th quantiles. The process was repeated but the treatment groups were swapped. In total, five sensitivity analyses were performed and the results were displayed graphically (see Figure 7).

Figure 7 shows how the estimates of the adjusted mean difference changed depending on the values imputed. This sensitivity analysis showed that there would need to be a large violation of the MAR assumption in the main analysis to render the results invalid and such a departure seems unlikely.

FIGURE 7.

The 12-month PRWE scores (points) for imputed quantiles.

In the primary analysis it was assumed that one item present per subscale was not defined as missing; in the second sensitivity analysis, the effect of requiring at least two, three, four and all items present in a subscale to not be called missing; was examined. Figure 8 showed that there was no difference in the estimated treatment effect at 12 months post randomisation for different ways of handling missing data in the PRWE subscales.

FIGURE 8.

The 12-month PRWE scores (points) for different minimum number of items required in the PRWE subscales.

Sensitivity analysis

Two sensitivity analyses were specified in the SHEAP:19 a PP analysis on PRWE outcomes to examine different assumptions about departures from randomised policies and a three-level model with participant within surgeon within recruitment centre to examine potential surgeon (random) effects. This model incorporated terms that allowed for possible heterogeneity in patients’ responses as a result of there being multiple recruiting surgeons as well as recruitment centres.

Subgroup analysis

There were two predefined subgroups analyses for DRAFFT 2 based on the two clinical stratifying variables (i.e. age and articular extension). These were performed using an extended model to formally test the interaction between each stratifying variable and the treatment factor. The interaction test results are reported in Figure 9 as adjusted mean differences and 95% CIs. Two models were fitted: one fitting an interaction term with age and one fitting an interaction term with articular extension. A linear mixed model adjusting for baseline PRWE score, age and articular extension as fixed effects and participant within recruitment centre was used as a base model to perform these analyses; time point (3 and 6 months) interactions with treatment effect were fitted. It is important to note that subgroup analyses are exploratory and hypothesis generating, so results from Figure 9 should be interpreted with caution. No significant difference between any of the predefined subgroups in treatment effect on the 12-month PRWE score was found.

FIGURE 9.

Forest plot of predefined clinical subgroups’ 12-month PRWE score.

Adverse events

Most adverse events were reported as complications in Chapter 2, Secondary outcomes.

There were 10 other SAEs (cast group, n = 5; K-wire group, n = 5); all were classified as ‘unexpected’ and all but one were classified as ‘not related’. The other SAE, which was classified as ‘unlikely to be related’, was a patient readmitted with discitis and primary hyperparathyroidism. Other SAEs included a fall leading to hip fracture, chest pain, removal of a cataract and admission to a psychiatric hospital.

Completion rate

A complete set of EQ-5D and health-care resource use values (from the NHS and PSS perspective) from baseline to 12 months post randomisation was collected from 290 out of 500 participants (58.0%). Completion rates of all the health-care resource items by treatment group for each time point are shown in Table 18 and the response rate of each domain of the EQ-5D-5L is presented in Appendix 2, Table 22. Our data are non-monotonic; that is, participants who did not complete the 3-month questionnaire could have completed the 6- or 12-month questionnaire.

Health-care resource use

The observed health-care resource use recorded by participants is presented Appendix 2, Table 23, by treatment group per follow-up time point. There were no significant differences in health-care resource utilisation rates between the treatment groups.

Health-care costs

The mean costs of the key resource inputs associated with the trial are summarised in Table 19. The mean unadjusted costs (SE) by treatment groups and follow-up time points, in 2018/19 prices (GBP) (available case). There were no significant differences in the mean cost between treatment groups except for the following: the mean initial treatment cost was higher in the K-wire group [£1520.86 (SE £16.52)] than in the cast group [£1363.69 (SE £15.76); t-test, p < 0.001], but the mean cost of treatment of complications between baseline and 12 months post randomisation was lower in the K-wire group [£11.59 (SE £6.28)] than in the cast group [£105.15 (SE £18.10); t-test, p < 0.001]. In terms of medications from baseline to 12 months post randomisation, those randomised to the cast group incurred a higher mean cost [£2.75 (SE £0.75)] than those in the K-wire group [£0.98 (SE £0.25); t-test, p = 0.027]. The mean additional cost, which refers to additional (private) cost items incurred by participants and their next of kin (e.g. travel expenditure, child care and help with housework), between baseline and 3 months post randomisation was higher in the K-wire group [£42.09 (SE £10.49)] than in the cast group [£19.03 (SE £3.58); t-test, p = 0.039].

Health utilities

The summary statistics of the EQ-5D utility scores for all observed cases across all time points by treatment groups are presented in Tables 10 and 11. There was no evidence of a difference in the EQ-5D utility between treatment groups at any time point and the mean QALY gain in the cast group [0.706 (SE 0.013)] was also not statistically significant from that in the K-wire group [0.707 (SE 0.011); t-test, p = 0.955].

Cost-effectiveness results

The incremental cost-effectiveness analysis results for the K-wire group compared with the cast group in the base-case analysis and in each of the sensitivity and subgroup analyses are shown in Table 20. The probability that manipulation with K-wire fixation is cost-effective at cost-effectiveness thresholds of £15,000, £20,000 and £30,000 per QALY gained is also presented. The NMB, cost-effectiveness acceptability curve and cost-effectiveness plane with the confidence ellipse for the base-case analysis and in each of the sensitivity and subgroup analyses are presented in Figures 10–16.

FIGURE 10.

Base-case analysis of K-wire vs. cast. (a) NMB; (b) cost-effectiveness acceptability curve; and (c) confidence ellipse on the cost-effectiveness plane.

FIGURE 11.

Sensitivity analysis (societal perspective) of K-wire vs. cast. (a) NMB; (b) cost-effectiveness acceptability curve; and (c) confidence ellipse on the cost-effectiveness plane.

FIGURE 12.

Sensitivity analysis (complete-case analysis) of K-wire vs. cast. (a) NMB; (b) cost-effectiveness acceptability curve; and (c) confidence ellipse on the cost-effectiveness plane.

FIGURE 13.

Subgroup analysis (aged < 50 years) of K-wire vs. cast. (a) NMB; (b) cost-effectiveness acceptability curve; and (c) confidence ellipse on the cost-effectiveness plane.

FIGURE 14.

Subgroup analysis (aged ≥ 50 years) of K-wire vs. cast. (a) NMB; (b) cost-effectiveness acceptability curve; and (c) confidence ellipse on the cost-effectiveness plane.

FIGURE 15.

Subgroup analysis (extra-articular extension) of K-wire vs. cast. (a) NMB; (b) cost-effectiveness acceptability curve; and (c) confidence ellipse on the cost-effectiveness plane.

FIGURE 16.

Subgroup analysis (intra-articular extension) of K-wire vs. cast. (a) NMB; (b) cost-effectiveness acceptability curve; and (c) confidence ellipse on the cost-effectiveness plane.

The base-case analysis showed that manipulation with K-wire fixation was dominated [higher cost (£29.65, 95% CI –£94.85 to £154.15)] and almost as effective (–0.007, 95% CI –0.03 to 0.016) when compared with the cast group from the NHS and PSS perspective. In addition, the probability of manipulation with K-wire fixation being cost-effective was < 0.5 at the assumed cost-effectiveness thresholds of £15,000, £20,000 and £30,000 per QALY, whereas the NMB was negative. Therefore, the base-case analysis indicated that manipulation with K-wire fixation is unlikely to be cost-effective relative to the use of a cast among the studied population.

Both sensitivity analyses (societal perspective and complete-case) showed similar results that supported the base-case finding that manipulation with K-wire fixation was dominated. The probability of manipulation with K-wire fixation being cost-effective relative to the use of a cast among the studied population was < 0.5 in both sensitivity analyses, and the NMB was negative.

The subgroup analyses showed similar results to the base-case finding in that manipulation with K-wire fixation was found to be unlikely to be cost-effective relative to manipulation followed by a cast in the studied population (probability < 0.5 and negative NMB) using the prespecified cost-effectiveness thresholds. In the intra-articular extension group, the ICER was £22,801 per QALY (a point estimate), which suggests that manipulation with K-wire fixation would not be cost-effective relative to the use of a cast at a cost-effectiveness threshold of £15,000 per QALY or £20,000 per QALY. In the intra-articular extension group, the ICER was £22,801 per QALY (a point estimate), which suggests that manipulation with K-wire fixation would likely not be cost-effective (probability of being cost-effective at 0.55) relative to the use of a cast at a cost-effectiveness threshold of £15,000 or £20,000 per QALY.

Recruitment

Between January 2017 and March 2019, a total of 2636 patients with a dorsally displaced fracture of the distal radius were screened in the recruitment centres. A total of 1441 patients met one or more of the exclusion criteria. Somewhat surprisingly, 338 of these patients were excluded because the injury was > 2 weeks old. Although some patients with an injury to the distal radius do try to manage this themselves without visiting the hospital, this is not very common in the case of a displaced fracture as, in such cases, there is often a visible deformity. It seems more likely that this exclusion criterion was met by patients whose fracture was initially managed non-operatively, but in whom fracture displacement or re-displacement subsequently occurred or was managed > 2 weeks after the index injury. It is common practice in many NHS hospitals for patients to undergo manipulation of a displaced distal radius fracture in the emergency department or a minor injuries unit and to then be followed up with repeat radiographs in the orthopaedic fracture clinic. Re-displacement can then occur in the second or third week. This in itself does raise questions about the optimal initial management of these injuries (see Chapter 6, Future research recommendations). A total of 104 patients were excluded because their fracture was open with a Gustilo grading > 1°. As the outcome in such cases is usually dictated more by the associated soft-tissue injury than by the underlying fracture, it is appropriate that these patients were excluded. A total of 222 patients were excluded because they were deemed to be unable to adhere to the trial procedures or complete questionnaires. This proportion is similar to that found in the first DRAFFT trial,4 and is in keeping with the fact that distal radius fractures are common in patients with cognitive impairment. A total of 284 patients were excluded during screening because the treating surgeon felt that the fracture would require open reduction and hence could not be treated with either of the two trial treatments. Again, this is in keeping with the fact that a proportion of patients with intra-articular fractures have an obvious step or gap in the radiocarpal joint surface that cannot be reduced by a closed manipulation of the fracture.

The great majority of patients who met the eligibility criteria and who were approached for their informed consent were happy to take part in the trial, but 196 patients declined, most commonly because they ‘did not want to take part in research’.

In addition to the 196 patients who declined to consent, 495 potentially eligible patients were not approached for consent into the trial because the treating clinician had a strong preference for a particular treatment. In 151 cases, the surgeon preferred one of the two treatments under investigation (cast group, n = 31; K-wire group, n = 120). Although the exclusion of these patients does affect the external validity of the trial, this is a relatively small number compared with the 500 patients who were included in the trial. The remaining patients (n = 344) were not offered the opportunity to enter the trial because the consulting surgeon had a preferred ‘other’ treatment. In 154 cases, this other treatment was not specified in the screening data. For the other 190 patients, some surgeons recommended external fixation, but the most commonly recommended treatment was plate fixation.

There is likely to have been some overlap in this group with the exclusion criterion ‘the articular surface of the fracture cannot be reduced by indirect means’, but we do not have radiographical data to confirm this. However, despite the results of the DRAFFT trial (which found no evidence that plate fixation was superior to K-wire fixation if a dorsally displaced fracture of the distal radius could be reduced without opening the fracture),4 and the subsequent national guidelines,47 some surgeons still routinely offer plate fixation to all patients for whom they are recommending surgical fixation for a distal radius fracture. 48 Excluding this group of patients may also have affected the generalisability of the trial but, again, this is a relatively small number compared with the 500 participants who were offered the chance to take part and consented to do so.

In the DRAFFT trial,4 patients were randomised to their treatment group before their surgery. This was in keeping with common practice at the time but did lead to some potentially eligible patients being excluded preoperatively if the surgeon was not confident that a closed reduction of the fracture could be achieved during surgery. Therefore, to prevent unnecessary exclusions, and facilitated by the increased availability of real-time online randomisation via operating theatre computers, DRAFFT 2 was designed such that randomisation was planned to take place after a closed reduction of the fracture had been achieved in the operating theatre, but before any fixation was performed. Patients who gave their informed consent before the reduction was attempted were advised that, if their surgeon felt that the manipulation of the fracture was unsatisfactory and that the fracture could not be reduced without opening the skin, they would not be randomised into the trial but the surgeon would proceed with open reduction and fixation, as per routine clinical practice. A total of 179 patients who consented to enter the trial were subsequently excluded before randomisation because the surgeon was unable to achieve or maintain a closed reduction intraoperatively. This is lower than the proportion of patients in the DRAFFT trial4 who were excluded preoperatively because the surgeon was uncertain that a closed reduction of the fracture could be achieved (40% of potentially eligible patients in the DRAFFT trial4 were excluded on this criterion), indicating that the use of real-time randomisation following the manipulation of the fracture did help to improve the external validity of the trial. This is worthy of note in the design of future studies.

Participants and treatment groups

Five hundred participants were randomised into the trial. The larger centres screened more eligible patients, but recruitment of participants was distributed across all of the recruitment centres apart from two that did not recruit any participants. The recruitment centres represent the range of major trauma centres, trauma units and local emergency hospitals that routinely treat patients with distal radius fracture in the NHS. Therefore, we can be confident that the participants were representative of the UK population with distal radius fractures.

A total of 255 participants were allocated to the cast group and 245 were allocated to the K-wire group. We anticipated some crossover of participants immediately after randomisation but, in fact, only 27 participants did not receive their allocated treatment. Twelve participants in the cast group crossed over to the K-wire group and four participants in the K-wire group crossed over to the cast group. The remaining participants underwent plate fixation (n = 10) or other surgery (n = 2). As part of the statistical analysis plan, we included a secondary PP analysis of the PRWE outcomes to supplement the primary ITT analysis, but, given the relatively small number of participants who did not receive their allocated treatment, we were reassured that non-compliance was unlikely to affect the integrity of the trial findings.

The baseline characteristics of the two groups were well balanced in terms of both participant demographics and pre-injury patient-reported wrist function and HRQoL. Fracture characteristics were also well balanced, with 72% of participants in both treatment groups having extra-articular fractures. This distribution was expected, as intra-articular fractures are those more likely to require open reduction and hence be excluded from the trial as per the eligibility criteria.

In both groups, the treatments were most commonly performed by an orthopaedic consultant (48%) or a specialist trainee under supervision (33%), which reflects routine clinical practice in the UK. As with all surgical interventions, the experience of the surgeon may affect the outcome of the surgery beyond the choice of treatment. Therefore, we were pleased to note that there was reasonable balance of senior surgeons (consultants or staff and associate specialists) across the groups. If anything, the proportion of procedures performed by senior surgeons was higher in the cast group (67%) than in the K-wire group (54%), which is interesting given that the K-wire fixation treatment may be considered the more ‘technically demanding’ of the two. However, both treatments are used routinely throughout the NHS. and the surgeons in both groups were very experienced in performing both treatments: over 80% of the 361 surgeons involved in the trial reported that they had performed > 20 procedures of each type before the trial started. In the group undergoing surgical fixation with K-wires, two or three 1.6-mm wires was the most common option, with surgeons using an equal mix of interfragmentary and Kapanji insertion techniques, which reflects routine clinical practice in the UK. In the cast group, the great majority of participants were treated with a plaster of Paris cast moulded around the full circumference of the wrist and forearm in the manner of a ‘close-contact’ cast. This again reflects routine practice, as plaster of Paris can be moulded to maintain fracture reduction more easily than the alternative cast material, fibreglass.

As anticipated, the number of patients who withdrew or were lost to follow-up increased slightly during the 1 year following randomisation. In the sample size calculation, we estimated the loss to follow-up to be 20% and, indeed, follow-up was 79% in the cast group and 80% in the K-wire group at the 12 months post randomisation point. In total, 499 out of 500 participants provided data to inform the primary analysis (as data from earlier time points were used in this analysis). As the trial also exceeded the minimum recruitment target of 460 participants (500 participants being randomised), we can be confident that the trial fulfilled the assumptions made in the sample size calculation.

Results

Health economic evaluation

The economic evaluation in this trial indicates that manipulation and K-wire fixation is dominated by manipulation followed by a moulded cast (i.e. K-wire fixation is more costly but no more effective). Therefore, K-wire fixation is unlikely to be cost-effective among adult patients who have sustained an acute dorsally displaced fracture of the distal radius.

This finding was consistent across the pre-planned sensitivity analyses and subgroup analyses except in the intra-articular extension subgroup, in which the probability that K-wire would be cost-effective relative to a cast was slightly above 0.5 when a cost-effectiveness threshold of £15,000 per QALY or £20,000 per QALY was applied. This appears to be driven by the difference in the mean cost of treatment of complications, complications being more common in the subgroup with intra-articular extension. The mean cost of treatment of complications in the cast group [£147.03 (SE £47.62)] was higher than that in the K-wire group [£2.95 (SE £0.50)] in the intra-articular extension subgroup analysis.

The initial treatment cost was higher in the K-wire group than in the cast group because of the cost of the K-wires, the cost of the theatre consumables and the longer time in the operating theatre. However, the cost of treatment of complications was higher in the cast group. This was because those in the cast group reported more further surgeries than those in the K-wire group between baseline and 6 weeks after discharge, specifically the loss of fracture reduction leading to further surgical intervention.

The mean cost of medications from baseline to 12 months post randomisation was higher in the cast group than in the K-wire group, and this was attributable to two participants taking risedronate (one for 30 days and one for 42 days), which has a higher unit cost than other medications. It is unlikely that the use of risedronate is associated with the choice of treatment in the trial, but both participants happened to be randomised to the cast group. If a t-test was performed without these two observations, the mean cost of the medication in the cast group would drop from £2.75 (SE £0.75) to £1.94 (SE £0.48) and there would not be a statistically significant difference in the mean cost of medications between the K-wire and cast groups (t-test, p = 0.074). Likewise, additional (non-NHS) costs were statistically significantly different between the K-wire and cast groups because one participant incurred an exceptionally high travel and help with housework cost between discharge and 3 months. If a t-test was performed without this single observation, there would not be a statistically significant difference in the mean additional costs between the K-wire and cast groups.

Of note, the analysis presented here differs from the published SHEAP19 in two ways. First, it differs in the measurement of the cost of the initial treatment. As the duration of the operation was significantly different between the two groups [31.2 minutes (SE 1.7 minutes) in the cast group compared with 44.2 minutes (SE 1.7 minutes) in the K-wire group; t-test, p < 0.001], we used the cost associated with the time that each patient spent in the operating theatre, instead of using only the cost of surgical staff, to obtain more comprehensive estimate of the overall cost of the treatment. It has been shown that staff costs account for only 65% of operating theatre time. 31 To avoid double-counting the cost of the surgeon’s time, the cost of surgical staff was not computed. Of note, the Healthcare Resource Group code includes a standard cost for operating theatre time, thus overestimating the cost of surgery, but, because this code is assigned to patients undergoing both treatments, this would not lead to any difference between groups. Second, we added a cost-effectiveness threshold of £15,000 per QALY in our analysis to reflect current trends in health-care decision-making.

Limitations

Recruiting patients to clinical trials in the context of urgent surgery is difficult. A concern before this trial started was that patients and/or surgeons would not be willing to take part. In fact, only 196 patients declined to take part in the study. A bigger issue was equipoise in the surgical community. A total of 495 potentially eligible patients were not offered the chance to take part in the trial because the treating surgeon had a clinical preference for a particular treatment; 120 patients were offered manipulation and K-wire fixation, 31 manipulation and cast and 344 other treatments or unspecified. Although these numbers are low in relation to the total of 2636 patients who were screened as part of the study, they do have an impact on the external validity of the trial.

A further anticipated limitation was crossover of participants from the allocated treatment. However, only 27 of the 500 participants did not receive their allocated treatment. The secondary PP analysis, that is the analysis that included only those participants who received their allocated treatment, confirmed the results of the primary ITT analysis, finding no evidence of a difference between the two treatment groups.

There was also some loss to follow-up in the trial, but this was in keeping with the loss to follow-up of 20% used in the sample size calculation, which indicated that a minimum of 460 participants should be recruited. As the trial recruited 500 participants, we can be confident that DRAFFT 2 fulfilled the assumptions made in the sample size calculation.

The final major limitation of the trial was that neither the treating clinicians nor the participants could be blind to the treatments. This is, of course, inevitable in the case of surgical interventions, as the wires are clearly visible to the patient and surgeon when removed. Assessment bias was minimised by the fact that the surgeons providing the interventions played no part in the assessment of the participants’ outcomes.

Future research recommendations

With regard to fractures of the distal radius, further health technology assessments are recommended to investigate the following:

• What is the optimal technique for immobilisation of a dorsally displaced distal radius fracture that does not require manipulation to achieve reduction?

• What are the optimal techniques for immobilisation of a dorsally displaced distal radius fracture following the first manipulation of the fracture?

• What is the optimal technique for providing pain relief to patients who require a reduction of a dorsally displaced distal radius fracture?

• What is the optimal regime for rehabilitation of the patient after immobilisation of their wrist for a fracture of the distal radius?

Furthermore, further research to explore patient treatment preferences could inform all future research in this area.

Trial team

Research associates

Emma Stoddard, Ella Riedel, James Glen, Jazmine McCooey, Heather Jarvis, Mat Williams, Toni De Freitas, Janet Sinclair, Liz Still, Glaxy Gray, Ian Venables, Alice Panes, David Triggs, Bradley Tallon, Monah Fareh, Anna Mcskeane, Nicci Kelsall, Zoe Saunders, Stephen Duberley, Maria Ciaccio, Alison Whitcher, Esther Zebracki, Eliza Foster, Steven Barnfield, Katherine Coates, Josephine Morley, Paula Brock, Angie Dempster, Elizabeth Corbishley, Deborah Bunn, Helen Howlett, Helen Shirley, Debbie Wilson, Lucy Dudgeon, Sue Brown, Kate Smith, Andrea Jones, Kathryn Lewis, Maria Mestre, Zoe Warnock, Martin Austin, Sangeetha Prasath, Carolyn Colvin, Charlotte Humphrey, Sarah Buckley, Thelma Darian, Elizabeth Denis, Susan O’Sullivan, Emma Craig, Emily Nash, Rosie Murdoch, Toby Nisbett, Gabbie Young, Jessica Summers, Eve Fletcher, Debbie Walters, Sarah Diment, Benjamin Wilson, Julie Cronin, Rachel Cowey Julie Colley, Ashley Turner, Liam Preece, Maria Baggott, Maria Letts, Elizabeth Cruddas, Abby Newdick, Tereze Cepelkova, Cherrelle DeSouza, Alexandra Bak, Michael Dunn, Isabel Carballo Horton, Damian Dunn, Charlotte Boustead, Joanna Teuke, Tracey Lee, Tracy Brear, Holly Maguire, Ida Ponce, Joanne Hiden, Nicola Collins, Clare Harrop, Lindsay Cunningham, Georgina Williamson, Richard Mccormick, Joanne Bradley-Potts, Leila Dehghani, Cathleen Chabo, Helen Sankey, Karen Smith, Jenny Baron, Stuart Watson, Donna Simpson, Nick Aitken and Heidi McColm.

Other acknowledgements

The DRAFFT 2 trial was supported by the NIHR Oxford Biomedical Research Centre.

List of recruitment centres

Addenbrooke’s Hospital – Cambridge University Hospitals NHS Foundation Trust.

Basingstoke and North Hampshire Hospital – Hampshire Hospitals NHS Foundation Trust.

Blackpool Victoria Hospital – Blackpool Teaching Hospitals NHS Foundation Trust.

Cumberland Infirmary – North Cumbria University Hospitals NHS Trust.

Eastbourne District General Hospital – East Sussex Healthcare NHS Trust.

Ipswich Hospital – East Suffolk and North Essex NHS Foundation Trust.

James Cook University Hospital – South Tees NHS Hospital Trust.

John Radcliffe Hospital – Oxford University Hospitals NHS Foundation Trust.

Leicester General Hospital – University Hospitals of Leicester NHS Trust.

Luton & Dunstable Hospital – Luton & Dunstable University Hospital NHS Foundation Trust.

Manchester Royal Infirmary – Manchester University NHS Foundation Trust.

Musgrove Park Hospital – Somerset NHS Foundation Trust.

North Tyneside General Hospital – Northumbria Healthcare NHS Foundation Trust.

Northampton General Hospital – Northampton General Hospital NHS Trust.

Peterborough City Hospital – North West Anglia NHS Foundation Trust.

Pinderfields Hospital – Mid Yorkshire Hospitals NHS Trust.

Poole Hospital – Poole Hospital NHS Foundation Trust.

Royal Berkshire Hospital – Royal Berkshire NHS Foundation Trust.

Royal Blackburn Hospital – East Lancashire Hospitals NHS Trust.

Royal Cornwall Hospital – Royal Cornwall Hospitals NHS Trust.

Royal Derby Hospital – University Hospitals of Derby and Burton NHS Trust.

Royal Hampshire County Hospital – Hampshire Hospitals NHS Foundation Trust.

Royal Stoke University Hospital – University Hospitals of North Midlands NHS Trust.

Royal Victoria Infirmary – Newcastle upon Tyne NHS Trust.

Salisbury District Hospital – Salisbury NHS Foundation Trust.

Sandwell General Hospital – Sandwell and West Birmingham Hospitals NHS Trust.

Southampton General Hospital – University Hospital Southampton NHS Foundation Trust.

Southmead Hospital – North Bristol NHS Trust.

St. George’s University of London – St George’s University Hospitals NHS Foundation Trust.

Tunbridge Wells Hospital – Maidstone and Tunbridge Wells NHS Trust.

University Hospital (Coventry) – University Hospitals Coventry and Warwickshire NHS Trust.

University Hospital Llandough – Cardiff and Vale University Health Board.

University Hospital of North Tees – North Tees and Hartlepool NHS Foundation Trust.

Whiston Hospital – St Helens and Knowsley Teaching Hospitals NHS Trust.

Wrightington Hospital – Wrightington, Wigan and Leigh NHS Foundation Trust.

Wythenshawe Hospital – Manchester University NHS Foundation Trust.

Contributions of authors

Matthew L Costa (https://orcid.org/0000-0003-3644-1388) (Chief Investigator) was involved in the study conception and design, developed the protocol, had clinical responsibility, and was involved in writing and reviewing the report.

Juul Achten (https://orcid.org/0000-0002-8857-5743) was involved in the study conception and design, developed the protocol, was a member of the TMG, and was involved in writing and reviewing the report.

Alexander Ooms (https://orcid.org/0000-0003-1877-8323) was a member of TMG, was responsible for the statistical analysis of the trial, and was involved in writing and reviewing the report.

May Ee Png (https://orcid.org/0000-0001-5876-9363) was a member of the TMG, was responsible for the health economics analysis, and was involved in writing and reviewing the report.

Jonathan Cook (https://orcid.org/0000-0002-4156-6989) developed the protocol, was a member of TMG, was responsible for the statistical analysis of the trial, and was involved in writing and reviewing the report.

Melina Dritsaki (https://orcid.org/0000-0002-1673-3036) developed the protocol, was a member of TMG and was involved in reviewing the health economic analyses and the report.

Sarah E Lamb (https://orcid.org/0000-0003-4349-7195) was involved in the study conception and design, developed the protocol, was a member of the TMG and was involved in reviewing the report.

Robin Lerner (https://orcid.org/0000-0002-8372-8181) was involved in study management, was a member of the TMG and was involved in reviewing the report.

Kylea Draper (https://orcid.org/0000-0001-6900-6134) was involved in study management, was a member of the TMG and was involved in writing the report.

Marta Campolier (https://orcid.org/0000-0002-7168-2534) was involved in study management, was a member of the TMG, and was involved in writing and reviewing the report.

Helen Dakin (https://orcid.org/0000-0003-3255-748X) was involved in reviewing the health economic analyses and the report.

Alwin McGibbon (https://orcid.org/0000-0002-5116-9063) developed the protocol, was a member of TMG and was involved in reviewing the report.

Nicholas Parsons (https://orcid.org/0000-0001-9975-888X) was involved in study conception and design, developed the protocol, was a member of the TMG and was involved in reviewing the report.

Helen Hedley (https://orcid.org/0000-0001-5324-9019) was involved in study conception and design, developed the protocol, was a member of the TMG and was involved in reviewing the report.

Joseph Dias (https://orcid.org/0000-0001-5360-4543) was involved in study conception and design, developed the protocol, was a member of the TMG, and was involved in writing and reviewing the report.

Publication

Costa ML, Achten J, Ooms A, Png ME, Cook JA, Lamb SE, et al. Surgical fixation with K-wires versus casting in adults with fracture of distal radius: DRAFFT2 multicentre randomised clinical trial. BMJ 2022;376:e068041.

Data-sharing statement

All data requests should be submitted to the corresponding author for consideration. Access to available anonymised data may be granted following review.

Patient data

This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care.