Abstract
Aims
The aims of this study were to report the outcomes of patients with a complex fracture of the lower limb in the five years after they took part in the Wound Healing in Surgery for Trauma (WHIST) trial.
Methods
The WHIST trial compared negative pressure wound therapy (NPWT) dressings with standard dressings applied at the end of the first operation for patients undergoing internal fixation of a complex fracture of the lower limb. Complex fractures included periarticular fractures and open fractures when the wound could be closed primarily at the end of the first debridement. A total of 1,548 patients aged ≥ 16 years completed the initial follow-up, six months after injury. In this study we report the pre-planned analysis of outcome data up to five years. Patients reported their Disability Rating Index (DRI) (0 to 100, in which 100 = total disability), and health-related quality of life, chronic pain scores and neuropathic pain scores annually, using a self-reported questionnaire. Complications, including further surgery related to the fracture, were also recorded.
Results
A total of 1,015 of the original patients (66%) provided at least one set of outcome data during the five years of follow-up. There was no evidence of a difference in patient-reported disability between the two groups at five years (NPWT group mean DRI 30.0 (SD 26.5), standard dressing group mean DRI 31.5 (SD 28.8), adjusted difference -0.86 (95% CI -4.14 to 2.40; p = 0.609). There was also no evidence of a difference in the complication rates at this time.
Conclusion
We found no evidence of a difference in disability ratings between NPWT compared with standard wound dressings in the five years following the surgical treatment of a complex fracture of the lower limb. Patients in both groups reported high levels of persistent disability and reduced quality of life, with little evidence of improvement during this time.
Cite this article: Bone Joint J 2024;106-B(8):858–864.
Take home message
This five-year follow-up study found no evidence of a difference in disability, quality of life, pain, or the requirement for further surgery between patients treated with negative pressure wound therapy versus standard dressings following fixation of a complex fracture of the lower limb.
However, participants reported persistently high levels of chronic pain and neuropahtic symptoms at five years after their injury.
Introduction
Complex fractures of the lower limb are associated with a high risk of complications,1-3 and the cost of treating these injuries is extremely high for both patients and healthcare systems.4-8
The Wound Healing in Surgery for Trauma (WHIST) trial was a multicentre, randomized trial, embedded in the UK Major Trauma Network, which recruited patients aged ≥ 16 years with a complex fracture of the lower limb.9 The trial compared two types of wound dressing, negative pressure wound therapy (NPWT) and standard dressings not involving negative pressure, which were applied at the end of the first surgical procedure after fixation of the fracture. The fractures included periarticular fractures and open fractures when the wound could be closed primarily at the end of the first debridement. The authors reported no statistically significant difference between the groups in the patients’ Disability Rating Index (DRI)10 or health-related quality of life six months after injury, at which time, however, they described high levels of disability and low quality of life compared with their pre-injury levels.11 The aim of this study was to report the outcomes of the patients in this trial in a pre-planned analysis of the five-year follow-up.
Methods
The trial was approved by the National Research Ethics Service in England and registered with the International Standard Randomised Controlled Trials database (ISRCTN12702354). It was funded by the National Institute of Health and Care Research (ref. no. 14/199/14) and sponsored by the University of Oxford. A full description of the trial and its findings up to six months has been published.11
A total of 1,548 patients were consented and randomized on a 1:1 basis to treatment either with NPWT or standard wound dressings, at the end of the first surgical procedure for their complex fracture of the lower limb. Patients were excluded if they presented > 72 hours after injury, their wound could not be primarily closed, or they were unable to adhere to the procedures involved in the trial. The five-year analysis included only those who consented to longer-term follow-up. Patients were excluded from this analysis if they were randomized in error, retrospectively declined consent, or withdrew and requested that their data should be removed, or consented to the reporting of routine data follow-up only.
Patients were followed up annually for five years after injury. Outcome data, including scores for disability, quality of life, pain, and complications, were collected by postal or electronic questionnaires with telephone follow-up for non-responders.
The primary outcome measure was the patient-reported DRI, which is a self-administered, 12-item visual analogue scale (VAS) questionnaire assessing the patients’ rating of their disability.10 For each item, they score their ability to carry out the activity from 0 (without difficulty) to 100 (not at all). Total DRI scores are calculated as a mean across all items, with higher scores indicating greater disability.
There were four secondary outcome measures. The first was the EuroQol five-dimension five-level questionnaire (EQ-5D-5L), a validated measure of health-related quality of life consisting of a five-dimension classification system with five levels of response (EQ-5D-5L utility) and a separate VAS (EQ-VAS).12,13 These responses were converted to multi-attribute utility (MAU) scores using tariffs currently under development for England.4 The scale is such that 1 is equivalent to perfect health, 0 is equivalent to death, and negative scores are possible. The EQ-VAS ranges from 0 (worst health) to 100 (best health).
The next secondary outcome was pain (VAS). Patients rated their pain “today” on an 11-point (0 to 10) scale where 0 represents “no pain” and 10 represents “pain as severe as you can imagine.”
The third secondary outcome was the Doleur Neuropathique Questionnaire (DN4), a short validated neuropathic pain screening tool comprising seven questions.14 This tool is recommended by the International Association for the Study of Pain (IASP).15 Each question has a yes/no answer option, and total scores are the number of questions which are answered with “yes”. Scores of > 3 are likely to be indicative of neuropathic pain.
The final outcome measure was complications. Patients were asked to report on wound-healing complications, antibiotic use, further surgery, and any other related complications using a short series of yes/no questions. The complications were verified by the recruiting hospital team where possible.
Statistical analysis
All the analyses were performed according to the intention-to-treat (ITT) principle using available patients only. Means and SDs of DRI scores, at each year of follow-up, were used to assess temporal trends during the study. A similar approach was also used for EQ-5D-5L utility and EQ-VAS scores. DRI and EQ-5D scores from baseline (pre-injury) to five-year follow-up were analyzed with multilevel mixed-effects linear regression models using repeated measures over time (level 1) nested within patients (level 2). Data from all timepoints, including the short-term follow-ups at three and six months, were included in these models. The models included a random effect to account for any heterogeneity in response due to recruitment centre (level 3), and fixed effects to adjust for open versus closed fractures, Injury Severity Score (ISS) level (≤ 15 vs ≥ 16), the patient’s age, sex, and pre-injury scores. Time was included as a categorical variable, and a treatment-by-time interaction was included in the model.
For each treatment group, means and SDs are reported at each annual follow-up, and adjusted differences between groups with associated 95% CIs and p-values are also reported. Pain scores were summarized for each group at each timepoint using means, SDs, medians and IQRs. The two groups were compared at each timepoint using a Mann-Whitney U test and p-values were calculated based on the normal approximation.
The number and proportion of patients in each group with neuropathic pain (i.e. DN4 ≥ 3) at each follow-up timepoint (one to five years) was calculated. A multilevel mixed effect logistic regression model with repeated measures (level 1) nested within patients (level 2) was used to compare rates of neuropathic pain in the two groups. The model was adjusted for recruitment centre as a random effect (level 3), and fixed effects were included to adjust for open versus closed fractures, ISS level (≤ 15 vs ≥ 16) and the patient’s age and sex. Data from all timepoints, including the short-term follow-ups at three and six months, were included in this model.
Results are presented as odds ratios (ORs) with associated 95% CIs. The unadjusted OR and associated 95% CIs are also reported. Complications were summarized based on the total numbers of patients reporting each adverse event, with no formal test of association due to the low numbers in the groups. All tests were two-sided and significance was assessed at the 5% level. All analyses used complete-case data and were implemented in R Statistical Software v. 4.3.1 (R Foundation for Statistical Computing, Austria) and Stata Release 17 (StataCorp, USA).
Results
Of the original 1,548 patients in the WHIST trial, 1,520 (98.2%) were eligible to be reviewed five years after injury and 1,015 (66.8%) returned at least one follow-up questionnaire (Figure 1).
Fig. 1
Details of the patients who were analyzed at the different timepoints.
The baseline demographic data of the 1,015 patients whose results at five years were included in the analysis are shown in Table I.
Table I.
Baseline characteristics of the 1,015 patients reviewed at five years who returned at least one year follow-up questionnaire.
| Characteristic | NPWT | Standard dressing |
|---|---|---|
| Patients, n | 527 | 488 |
| Sex, n (%) | ||
| Male | 306 (58.1) | 301 (61.7) |
| Female | 221 (41.9) | 187 (38.3) |
| Mean age, yrs (SD) | 50.5 (18.84) | 50.1 (18.80) |
| Injury Severity Score ≤ 15, n (%) | 414 (78.6) | 391 (80.1) |
| Closed fracture, n (%) | 429 (81.4) | 396 (81.1) |
-
NPWT, negative pressure wound therapy.
Compared with the patients in the first phase of the WHIST trial (n = 1,548), those who completed this five-year follow-up (n = 1,015) were of a similar age (mean 49.8 years (SD 18.8) vs 50.3 years (SD 20.3)) and reported similar pre-injury DRI scores (13.22 (SD 22.63) vs 14.94 (SD 24.19)). The proportion of male and female patients who took part in the longer-term follow-up was similar to those in the first phase (males 60% vs 62%).
Of the 1,015 patients who were alive and willing to provide longer-term follow-up data, 850 (84%) were followed up at one year and 664 (65%) completed questionnaires at five years: 335 from the NPWT group and 329 from the standard dressing group. There were 121 deaths: 65 in the NPWT group and 56 in the standard treatment group (Figure 1).
Means, SDs, and differences for the DRI, EQ-5D utility, and VAS scores for years 1 to 5 are shown in Table II. There was no evidence of a difference between the scores in the two groups at each year of follow-up.
Table II.
Analysis of Disability Rating Index, EuroQol five-dimension five-level health questionnaire utility score, EuroQol visual analogue scale from one to five years after injury.
| Score | NPWT | Standard dressing | Adjusted difference (95% CI) | p-value* | ||
|---|---|---|---|---|---|---|
| n | Mean (SD) | n | Mean (SD) | |||
| DRI | ||||||
| 1 year | 411 | 34.9 (27.6) | 374 | 35.9 (28.5) | -1.84 (-4.94 to 1.27) | 0.247 |
| 2 years | 381 | 31.0 (26.7) | 338 | 32.3 (28.1) | -1.07 (-4.25 to 2.11) | 0.511 |
| 3 years | 364 | 30.8 (26.7) | 325 | 32.7 (28.4) | -1.93 (-5.15 to 1.29) | 0.241 |
| 4 years | 324 | 30.5 (26.8) | 310 | 30.8 (27.7) | -0.42 (-3.71 to 2.87) | 0.803 |
| 5 years | 320 | 30.0 (26.5) | 314 | 31.5 (28.8) | -0.86 (-4.14 to 2.43) | 0.609 |
| EQ-5D-5L utility | ||||||
| 1 year | 442 | 0.59 (0.30) | 401 | 0.59 (0.30) | 0.01 (-0.03 to 0.04) | 0.660 |
| 2 years | 403 | 0.60 (0.30) | 366 | 0.62 (0.28) | 0.01 (-0.02 to 0.05) | 0.485 |
| 3 years | 379 | 0.67 (0.27) | 340 | 0.64 (0.30) | 0.03 (0.00 to 0.07) | 0.069 |
| 4 years | 335 | 0.67 (0.28) | 314 | 0.67 (0.29) | 0.01 (-0.03 to 0.04) | 0.700 |
| 5 years | 326 | 0.69 (0.26) | 324 | 0.64 (0.33) | 0.03 (0.00 to 0.07) | 0.059 |
| EQ- VAS | ||||||
| 1 year | 441 | 70.3 (22.6) | 406 | 70.7 (23.1) | 0.08 (-2.61 to 2.77) | 0.954 |
| 2 years | 406 | 73.4 (21.2) | 371 | 71.2 (22.9) | 2.00 (-0.76 to 4.76) | 0.156 |
| 3 years | 381 | 73.1 (22.1) | 342 | 71.8 (23.3) | 1.14 (-1.69 to 3.96) | 0.431 |
| 4 years | 339 | 72.6 (22.6) | 310 | 71.6 (23.7) | 0.82 (-2.07 to 3.72) | 0.578 |
| 5 years | 335 | 74.3 (21.8) | 328 | 71.7 (23.3) | 1.28 (-1.61 to 4.17) | 0.384 |
-
*
Mann-Whitney U test.
-
DRI, Disability Rating Index; EQ-5D-5L, EuroQol five-dimension five-level health questionnaire; EQ-VAS, EuroQol visual analogue scale.
Figure 2 shows the pooled data from both groups, including both short- and long-term outcomes. Pre-injury and, where available, post-injury (collected after consent was provided) values are included. Regarding the trajectory of recovery over the five years, there was little evidence of improvement in DRI or EQ-5D scores after the first year.
Fig. 2
Boxplots of pooled Disability Rating Index (DRI), EuroQol five-dimension five-level (EQ-5D-5L) utility and visual analogue scale (VAS) scores over the five years of follow-up. Pre-injury, post-injury, three and and six month data have also been added. The DRI was collected post-injury.
Pain scores, as measured with a VAS, are summarized in Table III and Table IV. There was no evidence of a difference in pain scores or neuropathic pain scores between the groups at any timepoint during the five years.
Table III.
Pain scores from one to five years after injury.
| Timepoint | NPWT | Standard dressing | p-value | ||||
|---|---|---|---|---|---|---|---|
| Mean (SD) | Median (IQR) | Total | Mean (SD) | Median (IQR) | Total | ||
| 1 year | 2.8 (2.7) | 2 (1 to 5) | 439 | 2.9 (2.6) | 2 (1 to 5) | 404 | 0.381 |
| 2 years | 2.6 (2.5) | 2 (1 to 5) | 405 | 2.6 (2.6) | 2 (0 to 4) | 370 | 0.983 |
| 3 years | 2.5 (2.4) | 2 (0 to 4) | 379 | 2.5 (2.6) | 2 (0 to 4) | 342 | 0.987 |
| 4 years | 2.2 (2.4) | 1 (0 to 3) | 336 | 2.5 (2.7) | 1 (0 to 4) | 321 | 0.675 |
| 5 years | 2.1 (2.3) | 1 (0 to 3) | 334 | 2.4 (2.7) | 1 (0 to 4) | 328 | 0.483 |
-
*
Mann-Whitney U test.
-
NPWT, negative pressure wound therapy.
Table IV.
Analysis of Douleur Neuropathique Questionnaire scores from one to five years after injury.
| Timepoint | NPWT | Standard dressing | OR (95% CI) | p-value | |||
|---|---|---|---|---|---|---|---|
| n (%) | Total | n (%) | Total | Raw | Adjusted | ||
| 1 year | 133 (30.2) | 441 | 119 (29.5) | 403 | 1.03 (0.77 to 1.38) | 1.19 (0.68 to 2.10) | 0.532 |
| 2 years | 122 (30.8) | 396 | 110 (29.9) | 368 | 1.04 (0.77 to 1.42) | 0.98 (0.55 to 1.75) | 0.949 |
| 3 years | 117 (30.7) | 381 | 109 (32.0) | 341 | 0.94 (0.69 to 1.29) | 0.76 (0.42 to 1.38) | 0.370 |
| 4 years | 90 (26.7) | 337 | 102 (31.8) | 321 | 0.78 (0.56 to 1.10) | 0.62 (0.34 to 1.14) | 0.126 |
| 5 years | 96 (28.8) | 333 | 93 (28.4) | 328 | 1.02 (0.73 to 1.43) | 1.10 (0.60 to 2.05) | 0.755 |
-
NPWT, negative pressure wound therapy; OR, odds ratio.
The patients reported persistent pain, with high levels of neuropathic symptoms throughout follow-up and little evidence of improvement after the first year. The number and proportion of those reporting complications, or treatment for complications, in each group at each timepoint are summarized in Table V.
Table V.
Complications over time by treatment group.
| Complication | NPWT | Standard dressing |
|---|---|---|
| Problem with wound healing, n (%) | ||
| 1 year | 46 (6.0) | 37 (4.9) |
| 2 years | 33 (4.3) | 24 (3.2) |
| 3 years | 22 (2.8) | 11 (1.5) |
| 4 years | 17 (2.2) | 15 (2.0) |
| 5 years | 13 (1.7) | 15 (2.0) |
| Antibiotics for problem with wound, n (%) | ||
| 1 year | 27 (3.5) | 20 (2.7) |
| 2 years | 16 (2.1) | 16 (2.1) |
| 3 years | 13 (1.7) | 8 (1.1) |
| 4 years | 10 (1.3) | 7 (0.9) |
| 5 years | 8 (1.0) | 7 (0.9) |
| Surgery under GA for problem with wound, n (%) | ||
| 1 year | 15 (1.9) | 21 (2.8) |
| 2 years | 10 (1.3) | 17 (2.3) |
| 3 years | 14 (1.8) | 8 (1.1) |
| 4 years | 9 (1.2) | 4 (0.5) |
| 5 years | 5 (0.6) | 6 (0.8) |
| Further surgery because of fracture, n (%) | ||
| 1 year | 42 (5.4) | 27 (3.6) |
| 2 years | 45 (5.8) | 54 (7.2) |
| 3 years | 14 (1.8) | 10 (1.3) |
| 4 years | 14 (1.8) | 12 (1.6) |
| 5 years | 10 (1.3) | 8 (1.1) |
| Other complications, n (%) | ||
| 1 year | 105 (13.6) | 109 (14.6) |
| 2 years | 106 (13.7) | 87 (11.6) |
| 3 years | 70 (9.1) | 60 (8.0) |
| 4 years | 53 (6.9) | 47(6.3) |
| 5 years | 52 (6.7) | 54 (7.2) |
-
GA, general anaesthetic; NPWT, negative pressure wound therapy.
There was no evidence of a difference between the rates of complication in the two groups during the five years of follow-up. Complications requiring a medical intervention for wound-healing problems or related to the fracture were most common in the first two years after the injury and became less frequent with the passage of time. In the first year, 42 patients (5.4%) in the NPWT group and 27 (3.6%) in the standard dressing group had further surgery related to their fracture, mostly for removal of symptomatic metalwork. In the second year, this was 42 (5.4%) in the NPWT group and 54 (7.2%) in the standard dressing group. There was a similar pattern with regard to wound-healing complications.
Discussion
In keeping with the findings of the WHIST trial at six months, this five-year follow-up study showed no evidence of a difference in patient-reported disability between patients treated with NPWT and those treated with standard dressings following internal fixation of a complex fracture of the lower limb. There was also no evidence of a difference between the groups in health-related quality of life, pain, or complications related to their treatment.
Reviewing the overall outcomes of the patients in this trial provides an insight into the recovery of patients with these injuries more broadly. There was some improvement in disability between six and 12 months, but patients still reported a level of total disability of about 35%, one year after injury. There was also very little change thereafter up to five years. Health-related quality of life showed a similar pattern, with little change in EQ-5D utility or VAS scores after the first 12 months. The patients reported persistent pain and high levels of neuropathic pain, which remained five years after injury.16 This is important information for patients and clinicians who may be expecting continued recovery during this period.
With regard to complications, about 10% of patients in both groups required further surgery related to their fracture in the first two years. This was mostly for the removal of symptomatic metalwork, but a few patients required other surgery for delayed fracture healing. A similar proportion also required further surgery related to their wound in the first two years. However, only about 5% were treated with antibiotics during this time, suggesting that only half of these procedures were likely to have been related to local infection.
The strengths of this study include the reporting of patient-reported outcomes and the further operations in a well-defined cohort of patients. The main limitation is the fact that only 66% of the 1,548 patients from the original study were willing to provide follow-up data during the five years of follow-up. This percentage is in keeping with other mid-term follow-up studies involving musculoskeletal trauma, in which patients are reluctant to commit to answering questionnaires beyond the early phases of their rehabilitation.2,3,17 Since the number of patients who took part in this mid-term study was less than the number in the original report six months after injury, the CIs for the difference between the procedures are wider. Thus, this study did not have the same statistical power to detect subtle differences in outcome as the original report.
In conclusion, in this five-year follow-up study, we found no evidence of a difference in disability, quality of life, pain or the requirement for further surgery between patients treated with NPWT dressings compared with standard dressings following fixation of a complex fracture of the lower limb. There were also high levels of disability and reduced quality of life in the early stages of recovery after these serious injuries which persisted with little improvement between two and five years. Furthermore, there often remained chronic pain and neuropathic symptoms five years after injury. Patients and clinicians need to be aware of these long-term outcomes when discussing the rehabilitation and prognosis after the treament of these injuries.
References
1. Trompeter AJ , Knight R , Parsons N , Costa ML . The Orthopaedic Trauma Society classification of open fractures . Bone Joint J . 2020 ; 102-B ( 11 ): 1469 – 1474 . Crossref PubMed Google Scholar
2. Parsons N , Achten J , Costa ML , Collaborators F . Five-year outcomes for patients with a displaced fracture of the distal tibia . Bone Joint J . 2023 ; 105-B ( 7 ): 795 – 800 . Crossref PubMed Google Scholar
3. Costa ML , Achten J , Parsons NR , Collaborators W . Five-year outcomes for patients sustaining severe fractures of the lower limb: mid-term results from the Wound management for Open Lower Limb Fracture (WOLLF) trial . Bone Joint J . 2022 ; 104-B ( 5 ): 633 – 639 . Crossref PubMed Google Scholar
4. Parker B , Petrou S , Masters JPM , Achana F , Costa ML . Economic outcomes associated with deep surgical site infection in patients with an open fracture of the lower limb . Bone Joint J . 2018 ; 100-B ( 11 ): 1506 – 1510 . Crossref PubMed Google Scholar
5. MacKenzie EJ , Castillo RC , Jones AS , et al. Health-care costs associated with amputation or reconstruction of a limb-threatening injury . J Bone Joint Surg Am . 2007 ; 89-A ( 8 ): 1685 – 1692 . Crossref PubMed Google Scholar
6. Png ME , Madan JJ , Dritsaki M , et al. Cost-utility analysis of standard dressing compared with incisional negative-pressure wound therapy among patients with closed surgical wounds following major trauma to the lower limb . Bone Joint J . 2020 ; 102-B ( 8 ): 1072 – 1081 . Crossref PubMed Google Scholar
7. Petrou S , Parker B , Masters J , et al. Cost-effectiveness of negative-pressure wound therapy in adults with severe open fractures of the lower limb: evidence from the WOLLF randomized controlled trial . Bone Joint J . 2019 ; 101-B ( 11 ): 1392 – 1401 . Crossref PubMed Google Scholar
8. Png ME , Petrou S , Knight R , Masters J , Achten J , Costa ML . Economic outcomes associated with deep surgical site infection from lower limb fractures following major trauma . Bone Jt Open . 2022 ; 3 ( 5 ): 398 – 403 . Crossref PubMed Google Scholar
9. Costa ML , Achten J , Knight R , et al. Effect of incisional negative pressure wound therapy vs standard wound dressing on deep surgical site infection after surgery for lower limb fractures associated with major trauma: the WHIST randomized clinical trial . JAMA . 2020 ; 323 ( 6 ): 519 – 526 . Crossref PubMed Google Scholar
10. Salén BA , Spangfort EV , Nygren AL , Nordemar R . The Disability Rating Index: an instrument for the assessment of disability in clinical settings . J Clin Epidemiol . 1994 ; 47 ( 12 ): 1423 – 1435 . Crossref PubMed Google Scholar
11. Costa ML , Achten J , Knight R , et al. Negative-pressure wound therapy compared with standard dressings following surgical treatment of major trauma to the lower limb: the WHiST RCT . Health Technol Assess . 2020 ; 24 ( 38 ): 1 – 86 . Crossref PubMed Google Scholar
12. Brooks R , Charro F . EuroQol: the current state of play . Health Policy . 1996 ; 37 ( 1 ): 53 – 72 . Crossref PubMed Google Scholar
13. Dolan P . Modeling valuations for EuroQol health states . Med Care . 1997 ; 35 ( 11 ): 1095 – 1108 . Crossref PubMed Google Scholar
14. Bouhassira D , Lantéri-Minet M , Attal N , Laurent B , Touboul C . Prevalence of chronic pain with neuropathic characteristics in the general population . Pain . 2008 ; 136 ( 3 ): 380 – 387 . Crossref PubMed Google Scholar
15. Haanpää M , Attal N , Backonja M , et al. NeuPSIG guidelines on neuropathic pain assessment . Pain . 2011 ; 152 ( 1 ): 14 – 27 . Crossref PubMed Google Scholar
16. Keene DJ , Knight R , Bruce J , et al. Chronic pain with neuropathic characteristics after surgery for major trauma to the lower limb: prevalence, predictors, and association with pain severity, disability, and quality of life in the UK WHiST trial . Bone Joint J . 2021 ; 103-B ( 6 ): 1047 – 1054 . Crossref PubMed Google Scholar
17. Costa ML , Achten J , Rangan A , Lamb SE , Parsons NR . Percutaneous fixation with Kirschner wires versus volar locking-plate fixation in adults with dorsally displaced fracture of distal radius: five-year follow-up of a randomized controlled trial . Bone Joint J . 2019 ; 101-B ( 8 ): 978 – 983 . Crossref PubMed Google Scholar
Author contributions
M. L. Costa: Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Writing – original draft
J. Achten: Funding acquisition, Investigation, Methodology, Project administration, Writing – review & editing
R. Knight: Data curation, Funding acquisition, Methodology, Writing – review & editing
M. Campolier: Data curation, Project administration, Writing – review & editing
M. S. Massa: Formal analysis, Methodology, Writing – original draft
Funding statement
The authors disclose receipt of the following financial or material support for the research, authorship, and/or publication of this article: this project was funded by the UK National Institute for Health and Care Research Health Technology Assessment (HTA) Programme (14/199/14) and was supported by the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre. The funder has not been involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript nor in the decision to submit the manuscript for publication. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Smith & Nephew provided incisional NPWT dressings (PICO Single Use Negative Pressure Wound Therapy System) to recruiting centres for the purposes of the trial, but had no part in the design, conduct, or reporting of the study.
Data sharing
The data that support the findings for this study are available to other researchers from the corresponding author upon reasonable request.
Acknowledgements
We would like to thank all those involved in the long-term follow-up of the WHIST trial, including the patients and in particular Catherine Thompsett and Hannah Crook for their input in trial coordination and management. Professor Matthew Costa and Dr Sofia Massa had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Ethical review statement
This study was approved by the NHS West Midlands Coventry and Warwickshire Research Ethics Committe (REC reference 16WM0006).
Open access funding
The open access fee for this article was funded by the National Institute for Health and Care Research.
Open access statement
This article is distributed under the terms of the Creative Commons Attribution No Derivatives (CC BY-ND 4.0) licence (https://creativecommons.org/licenses/by-nd/4.0/), which permits the reuse of the work for any purpose, including commercially, provided the original author and source are credited; however, it cannot be distributed to others in any adapted form.
Trial registration number
ISRCTN12702354
Social media
Follow M. L. Costa on X @Oxford_Trauma
This article was primary edited by J. Scott.
