Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (Hand-2): study protocol for a randomised controlled trial.

BACKGROUND: Dupuytren's contractures (DC) are fibrous cords under the skin of the hand that cause one or more fingers to curl gradually and irreversibly towards the palm. These contractures are usually painless but can cause a loss of hand function. Two treatments for Dupuytren's contractures are widely used within the National Health Service (NHS) in the UK: removal of the contractures via surgery (limited fasciectomy) and division of the contractures via a needle inserted through the skin (needle fasciotomy). This study aims to establish the clinical and cost-effectiveness of needle fasciotomy (NF) versus limited fasciectomy (LF) for the treatment of DC in the NHS, in terms of patient-reported hand function and resource utilisation. METHODS/DESIGN: Hand-2 is a national multi-centre, two-arm, parallel-group randomised, non-inferiority trial. Patients will be eligible to join the trial if they are aged 18 years or older, have at least one previously untreated finger with a well-defined Dupuytren's contracture of 30° or greater that causes functional problems and is suitable for treatment with either LF or NF. Patients with a contracture of the distal interphalangeal joint only are ineligible. Eligible consenting patients will be randomised 1:1 to receive either NF or LF and will be followed up for 24 months post-treatment. A QuinteT Recruitment Intervention will be used to optimise recruitment. The primary outcome measure is the participant-reported assessment of hand function, assessed by the Hand Health Profile of the Patient Evaluation Measure (PEM) questionnaire at 12 months post-treatment. Secondary outcomes include other patient-reported measures, loss of finger movement, and cost-effectiveness, reported over the 24-month post-treatment. Embedded qualitative research will explore patient experiences and acceptability of treatment at 2 years post-surgery. DISCUSSION: This study will determine whether treatment with needle fasciotomy is non-inferior to limited fasciectomy in terms of patient-reported hand function at 12 months post-treatment. TRIAL REGISTRATION: International Standard Registered Clinical/soCial sTudy ISRCTN12525655. Registered on 18th September 2020.

'It's just a finger isn't it ': patients' perspectives of recovery following finger fractures and participation in surgical trials - a qualitative interview study.

OBJECTIVES: To (1) generate detailed, person-centred data about the experience of finger injury and treatment and (2) understand the patients' perspectives of research involvement with a view to informing better designed future studies in hand injury. DESIGN: Qualitative study using semistructured interviews and framework analysis. PARTICIPANTS: 19 participants who were part of the Cohort study of Patients' Outcomes for Finger Fractures and Joint Injuries study in a single secondary care centre in the UK. RESULTS: The results of this study showed that although finger injuries are frequently seen as minor by patients and healthcare professionals, their effects on peoples' lives are possibly greater than first anticipated. The relative importance of hand functioning means that the experience of treatment and recovery varies and is shaped by an individual's age, job, lifestyle and hobbies. These factors will also inform an individual's perspective on and willingness to participate in, hand research. Interviewees showed reluctance to accept randomisation in surgical trials. Interviewees would be more likely to participate in a study testing two variants of the same treatment modality (eg, surgery vs surgery), rather than two different modalities, (eg, surgery vs splint). The Patient-Reported Outcome Measure questionnaires that were used in this study were seen as less relevant by these patients. Pain, hand function and cosmetic appearance were considered important, meaningful outcomes. CONCLUSIONS: Patients with finger injuries need more support from healthcare professionals as they may experience more problems than first anticipated. Good communication by clinicians and empathy can help patients engage with the treatment pathway. Perceptions of an 'insignificant' injury and/or need for quick functional recovery will influence recruitment to future hand research (both positively and negatively). Accessible information about the functional and clinical consequences of a hand injury will be important in enabling participants to make fully informed decisions about participation.

Developing a core outcome set for hand fractures and joint injuries in adults.

The aim of this study was to develop a core outcome set of what to measure in all future clinical research on hand fractures and joint injuries in adults. Phase 1 consisted of steps to identify potential outcome domains through systematic review of published studies, and exploration of the patient perspective through qualitative research, consisting of 25 semi-structured interviews and five focus groups. Phase 2 involved key stakeholder groups (patients, hand surgeons, and hand therapists) prioritizing the outcome domains via a three-round international Delphi survey, with a final consensus meeting to agree the final core outcome set. The systematic review of 160 studies identified 74 outcome domains based on the World Health Organization International Classification of Functioning, Disability, and Health. Overall, 35 domains were generated through thematic analysis of the patient interviews and focus groups. The domains from these elements were synthesised to develop 37 outcome domains as the basis of the Delphi survey, with a further four generated from participant suggestions in Round 1. The Delphi survey identified 20 outcome domains as 'very important' for the core outcome set. At the consensus meeting, 27 participants from key stakeholder groups selected seven outcomes for the core outcome set: pain/discomfort with activity, pain/discomfort with rest, fine hand use/dexterity, self-hygiene/personal care, return to usual work/job, range of motion, and patient satisfaction with outcome/result. This set of core outcome domains is recommended as a minimum to be reported in all clinical research on hand fractures and joint injuries in adults. While this establishes what to measure, future work will focus on determining how best to measure these outcomes. By adopting this patient-centred core outcome set, consistency and comparability of studies will be improved, aiding meta-analysis and strengthening the evidence base for management of these common and impactful injuries.

Epidemiology of Hand Fractures and Dislocations in England and Wales Professional Cricketers.

This study describes hand fracture and dislocation injuries in terms of anatomical distribution, incidence and impact on playing time in registered professional adult male players of all 18 First Class England and Wales County Cricket clubs over a five-year period from 2010-2014. Prospectively collected injury surveillance data for 1st and 2nd Team matches (Twenty20, One day and four-day) and training were analysed. There were 109 hand fractures and 53 dislocations. Hand injury was commonest during fielding (60%, 98/162) compared to batting, bowling or wicket-keeping. Exposed parts of the hand including tips of all digits, the index finger, thumb ray and little finger ray were most frequently injured with 78% (125/160) of all injuries where anatomical location was recorded. Match injury incidence for batsmen was highest in four-day matches (0.071 injuries per 1000 overs batted) but for other player roles it was highest in Twenty20 matches (0.587 per 1000 overs bowled). Player unavailability for selection to play was incurred in 82% (89/109) of hand fractures but only 47% (25/53) of dislocations. This study clarifies the hand fracture and dislocation injury burden for this population.

A Systematic Review of Treatment Interventions for Metacarpal Shaft Fractures in Adults.

Metacarpal shaft fractures are common hand injuries that predominantly affect younger patients. There is wide variability in their treatment with no consensus on best practice. We performed a systematic review to assess the breadth and quality of available evidence supporting different treatment modalities for metacarpal shaft fractures of the finger digits in adults. A comprehensive search was conducted across multiple databases, in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 1600 records were identified; 7 studies fulfilled eligibility criteria and were included. No randomized controlled trials directly comparing surgery with nonsurgical treatment were found. One retrospective study compared nonsurgical with surgical treatment, whereas 6 compared surgical or nonsurgical treatments. Considerable heterogeneity between studies along with a high or critical risk of bias restricts direct comparison and conclusions. There is a lack of high-quality evidence to guide treatment, supporting the need for well-designed, multicenter trials to identify the most effective and cost-efficient treatment for metacarpal shaft fractures in adults.

Protocol for surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study.

INTRODUCTION: Metacarpal shaft fractures (MSF) are common traumatic hand injuries that usually affect young people of working age. They place a significant burden on healthcare resources and society; however, there is a lack of evidence to guide their treatment. Identifying the most beneficial and cost-efficient treatment will ensure optimisation of care and provide economic value for the National Health Service. The aim of this study is to assess the feasibility of a randomised controlled trial comparing surgical and non-surgical treatment for MSF in adults. METHODS AND ANALYSIS: This is a multicentre prospective cohort study, with a nested qualitative study consisting of patient interviews and focus groups, and an embedded factorial randomised substudy evaluating the use of text messages to maximise data collection and participant retention. The outcomes of interest include eligibility, recruitment and retention rates, completion of follow-up, evaluation of primary outcome measures, calculation of the minimal clinically important difference (MCID) for selected outcome measures and establishing the feasibility of data collection methods and appropriate time-points for use in a future trial. Data will be captured using a secure online data management system. Data analyses will be descriptive and a thematic inductive analysis will be used for qualitative data. Minimum clinically important effects for each patient-reported outcome measure will be estimated using anchor-based responsiveness statistics and distribution-based methods. ETHICS AND DISSEMINATION: This study has received ethical approval from the Research Ethics Committee and the Health Research Authority (REC reference 20/EE/0124). Results will be made available to patients, clinicians, researchers and the funder via peer-reviewed publications and conference presentations. Social media platforms, local media and feedback from the Patient Advisory Group will be used to maximise circulation of findings to patients and the public. TRIAL REGISTRATION NUMBER: ISRCTN13922779.

Common hand and wrist conditions: creation of UK research priorities defined by a James Lind Alliance Priority Setting Partnership.

OBJECTIVE: Prioritisation of important treatment uncertainties for 'Common Conditions Affecting the Hand and Wrist' via a UK-based James Lind Alliance Priority Setting Partnership. SETTING: This process was funded by a national charitable organisation and based in the UK. PARTICIPANTS: Anyone with experience of common conditions affecting the adult hand and wrist, including patients, carers and healthcare professionals. All treatment modalities delivered by a hand specialist, including therapists, surgeons or other allied professionals, were considered. INTERVENTIONS: Established James Lind Alliance Priority Setting Partnership methods were employed.Electronic and paper questionnaires identified potential uncertainties. These were subsequently confirmed using relevant, up-to-date systematic reviews. A final list of top 10 research uncertainties was developed via a face-to-face workshop with representation from patients and clinicians. Impact of research was sought by surveying hand clinicians electronically. OUTCOME MEASURES: The survey responses and prioritisation-both survey and workshop based. RESULTS: There were 889 individually submitted questions from the initial survey, refined to 59 uncertainties across 32 themes. Eight additional uncertainties were added from published literature before prioritisation by 261 participants and the workshop allowed the final top 10 list to be finalised. The top 10 has so far contributed to the award of over £3.8 million of competitively awarded funding. CONCLUSIONS: The Common Conditions in the Hand and Wrist Priority Setting Partnership identified important research questions and has allowed research funders to identify grant applications which are important to both patients and clinicians.

Developing a core outcome set for hand fractures and joint injuries in adults: a systematic review.

This study identifies the treatment outcome domains used in recently published studies on the treatment of hand fractures and joint injuries with the aim to inform development of a core outcome set. Seven databases were searched from January 2014 to March 2019 for randomized and quasi-randomized studies and large prospective observational studies. We identified 1777 verbatim outcomes in 160 eligible studies. From the verbatim outcomes we distinguished 639 unique outcomes, which we categorized into 74 outcome domains based on the World Health Organization International Classification of Functioning, Disability, and Health framework. The primary outcome was appropriately identified in only 65% (72/110) of randomized and quasi-randomized controlled trials. Of the 72 studies with a primary outcome identified, 74% (53/72) had an appropriate power calculation. The vast heterogeneity in outcome selection across studies highlights the need for a core outcome set of what outcomes to measure in future clinical research on hand fractures and joint injuries.

Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI).

BACKGROUND: Recruitment to randomised controlled trials (RCTs) can be challenging, with most trials not reaching recruitment targets. Randomised feasibility studies can be set up prior to a main trial to identify and overcome recruitment obstacles. This paper reports on an intervention-the QuinteT Recruitment Intervention (QRI)-to optimise recruitment within a randomised feasibility study of surgical treatments for patients with Dupuytren's contracture (the HAND-1 study). METHODS: The QRI was introduced in 2-phases: phase 1 sought to understand the recruitment challenges by interviewing trial staff, scrutinising screening logs and analysing audio-recorded patient consultations; in phase 2 a tailored plan of action consisting of recruiter feedback and training was delivered to address the identified challenges. RESULTS: Two key recruitment obstacles emerged: (1) issues with the recruitment pathway, in particular methods to identify potentially eligible patients and (2) equipoise of recruiters and patients. These were addressed by liaising with centres to share good practice and refine their pathway and by providing bespoke feedback and training on consent discussions to individual recruiters and centres whilst recruitment was ongoing. The HAND-1 study subsequently achieved its recruitment target. CONCLUSIONS: Transferable lessons learnt from the QRI in the feasibility study will be implemented in the definitive RCT, enabling a "head start" in the tackling of wider issues around screening methods and consent discussions in the set up/early recruitment study phases, with ongoing QRI addressing specific issues with new centres and recruiters. Findings from this study are likely to be relevant to other surgical and similar trials that are anticipated to encounter issues around patient and recruiter equipoise of treatments and variation in recruitment pathways across centres. The study also highlights the value of feasibility studies in fine-tuning design and conduct issues for definitive RCTs. Embedding a QRI in an RCT, at feasibility or main stage, offers an opportunity for a detailed and nuanced understanding of key recruitment challenges and the chance to address them in "real-time" as recruitment proceeds.

Wide-awake local anaesthesia no tourniquet (WALANT) vs regional or general anaesthesia for flexor tendon repair in adults: protocol for a systematic review and meta-analysis.

BACKGROUND: Flexor tendon injuries most commonly occur following a penetrating injury to the hand or wrist. These are challenging injuries and the standard treatment is surgical repair under general or regional anaesthesia. 'Wide-awake' surgery is an emerging technique in hand surgery where a conscious patient is operated on under local anaesthetic. The vasoconstrictive effect of adrenaline (epinephrine) creates a 'bloodless' operating field and a tourniquet is not required. The potential advantages include intra-operative testing of the repair; removal of the risks of general anaesthesia; reduced costs; no aerosol generation from intubation therefore reduced risk of COVID-19 spread to healthcare professionals. The aim of this study will be to systematically evaluate the evidence to determine if wide-awake surgery is superior to general/regional anaesthetic in adults who undergo flexor tendon repair. METHODS: We designed and registered a study protocol for a systematic review and meta-analysis of comparative and non-comparative studies. The primary outcome will be functional active range of motion. Secondary outcomes will be complications, resource use (operative time) and patient-reported outcome measures. A comprehensive literature search will be conducted (from 1946 to present) in MEDLINE, EMBASE, CINAHL, and Cochrane Library. Grey literature will be identified through Open Grey, dissertation databases and clinical trials registers. All studies on wide-awake surgery for flexor tendon repair will be included. The comparator will be general or regional anaesthesia. No limitations will be imposed on peer review status or language of publication. Two investigators will independently screen all citations, full-text articles and abstract data. Potential conflicts will be resolved through discussion or referral to a third author when necessary. The study methodological quality (or bias) will be appraised using an appropriate tool. If feasible, we will conduct a random effects meta-analysis. DISCUSSION: This systematic review will summarise the best available evidence and definitively establish if function, complications, cost, or patient-reported outcomes are improved when flexor tendons are repaired using wide-awake technique. It will determine if this novel approach is superior to general or regional anaesthesia. This knowledge will help guide hand surgeons by continuing to improve outcomes from flexor tendon injuries. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020182196.

Percutaneous pinning for treating distal radial fractures in adults.

BACKGROUND: Fracture of the distal radius is a common clinical problem. A key method of surgical fixation is percutaneous pinning, involving the insertion of wires through the skin to stabilise the fracture. This is an update of a Cochrane Review published in 2007. OBJECTIVES: To assess the effects (benefits and harms) of percutaneous pinning versus cast immobilisation alone and of different methods and techniques of percutaneous pinning, modalities or duration of immobilisation after pinning, and methods or timing of pin or wire removal for treating fractures of the distal radius in adults. Our primary focus was on dorsally displaced fractures. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, trial registers, conference proceedings and reference lists of articles up to June 2019. SELECTION CRITERIA: Randomised or quasi-randomised controlled clinical trials involving adults with a fracture of the distal radius, which compared percutaneous pinning with non-surgical treatment or different aspects of percutaneous pinning. Our main outcomes were patient-reported function at the short term (up to three months), medium term (three up to 12 months) and long term (greater than 12 months); overall numbers of participants with complications requiring secondary treatment and any complication; grip strength and health-related quality of life at 12 months. DATA COLLECTION AND ANALYSIS: At least two review authors independently performed study screening and selection, 'Risk of bias' assessment and data extraction. We pooled data where appropriate and used GRADE for assessing the quality of evidence for each outcome. MAIN RESULTS: We included 21 randomised controlled trials (RCTs) and five quasi-RCTs, involving 1946 generally older and female adults with dorsally displaced and potentially or evidently unstable distal radial fractures. Trial populations varied but the majority of studies reported mean ages in the sixth decade or older. All trials were at high risk of bias, invariably performance bias - which for most trials reflected the impracticality of blinding care providers or participants to treatment allocation - and often detection bias and selective reporting bias. Allocation concealment was secure in one trial only. All trials reported outcomes incompletely. The studies tested one of 10 comparisons. In the following, we report on those of the main outcomes for which evidence was available. No subgroup analysis, such as by pinning methods, was viable. Eleven heterogeneous trials involving 917 participants compared percutaneous pinning with plaster cast immobilisation after closed reduction of the fracture. The quality of the evidence was very low for all reported outcomes. Thus, we are uncertain if percutaneous pinning compared with plaster cast alone makes any difference to patient-reported function, measured using the DASH questionnaire, at six weeks or six months (incomplete data from one trial). Overall numbers of participants with complications were not reported. Redisplacement resulting in secondary treatment occurred on average in 12% (range 3.3% to 75%) of participants treated by cast alone (six trials) whereas pin tract infection requiring antibiotics and, often, early wire removal, occurred on average in 7.7% (range 0% to 15%) of pinning group participants (seven trials). We are uncertain whether pinning makes a difference to the incidence of complex regional pain syndrome, reported in four studies. Although two studies found finger stiffness after cast removal was less common after pinning (20% versus 36%), the treatment implications were not reported. Other reported complications were mainly surgery-related. Based on incomplete data or qualitative statements from only four studies, we are uncertain of the effects of pinning on grip strength at 12 months. We are uncertain if percutaneous pinning compared with plaster cast alone makes any difference to patient-reported quality of life at four months (one study). Five comparisons of different pinning methods were made by six trials in all. One of these trials, which reported results for 96 participants, compared Kapandji intrafocal pinning (2 or 3 wires) with early mobilisation versus trans-styloid fixation (2 wires) with six weeks cast immobilisation. We are uncertain whether Kapandji pinning slightly increases the risk of superficial radial nerve symptoms or complex regional pain syndrome, or whether it makes a difference in grip strength at 12 months (very low-quality evidence). Two small trials using two distinct pinning techniques compared biodegradable pins versus metal pins in 70 participants. Although very low-quality evidence, the extra demands at surgery of insertion of biodegradable pins and excess of serious complications (e.g. severe osteolytic reactions) associated with biodegradable material are important findings. Three poorly-reported trials involving 168 participants compared burying of wire ends versus leaving them exposed. We are uncertain whether burying of wires reduces the incidence of superficial infection (very low-quality evidence). There is low-quality evidence that burying of wires may be associated with a higher risk of requiring more invasive treatment for wire removal. Four small trials compared different types or duration of postoperative immobilisation. Very low-quality evidence of small between-group differences in individual complications and grip strength at 17 weeks, means we are uncertain of the effects of positioning the wrist in dorsiflexion versus palmar flexion during cast immobilisation following pinning of redisplaced fractures (one trial; 60 participants). Three small heterogeneous trials compared cast immobilisation for one week (early mobilisation) versus four or six weeks after percutaneous pinning in 170 people. Although we note one trial using Kapandji pinning reported more complications in the early group, the very low-quality evidence means there is uncertainty of the effects of early mobilisation on overall and individual complications, or grip strength at 12 months. No trials tested different methods for, or timing of, pin/wire removal. AUTHORS' CONCLUSIONS: Overall, there is insufficient RCT evidence to inform on the role of percutaneous pinning versus cast immobilisation alone or associated treatment decisions such as method of pinning, burying or not of wire ends, wrist position and duration of immobilisation after pinning. Although very low-quality evidence, the serious complications associated with biodegradable materials is noteworthy. We advise waiting on the results of a large ongoing study comparing pinning with plaster cast treatment as these could help inform future research.

Treatment interventions for hand fractures and joint injuries: a scoping review of randomized controlled trials.

The aim of this study was to identify and assess all existing randomized studies on treatment interventions for hand fractures and joint injuries, to inform practice and plan future research. PubMed, Cochrane CENTRAL, MEDLINE and Embase were searched. We identified 78 randomized controlled trials published over 35 years, covering seven anatomical areas of the hand. We report on sources of bias, sample size, follow-up length and retention, outcome measures and reporting. In terms of interventions studied, the trials were extremely heterogeneous, so it is difficult to draw conclusions on individual treatments. The published randomized controlled clinical trial evidence for hand fractures and joint injuries is narrow in scope and of generally low methodological quality. Mapping provides a useful resource and stepping-stone for planning further research. There is a need for high-quality, collaborative research to guide management of a wider range of common hand injuries.

Open Versus Arthroscopic Repair of 1B Ulnar-Sided Triangular Fibrocartilage Complex Tears: A Systematic Review.

Background: Peripheral 1B tears of the triangular fibrocartilage complex (TFCC) can result in distal radioulnar joint (DRUJ) instability. In the context of associated DRUJ instability, combined evidence supports successful outcomes for peripheral tear repair. Methods: The aim of this systematic review (SR) was to compare the surgical treatment of 1B TFCC tears via arthroscopic versus open methods of repair. The primary outcome measure was restored DRUJ stability. The secondary outcome measures included patient-reported outcomes and clinical outcome measures. An electronic database search of Ovid Embase, PubMed, and the Cochrane Central Register of Controlled Trials was performed to cover a 20-year period. Two authors independently screened records for eligibility and extracted data. Results: Only 3 studies met the strict inclusion criteria, highlighting the poor evidence base for TFCC 1B repairs. Hence, a "secondary analysis" group was developed with modified inclusion criteria which included a further 7 studies for analysis. Pooled data from the primary and secondary analysis groups demonstrated that postoperative DRUJ stability was achieved following open repair in 84% (76/90) of cases and following arthroscopic repair in 86% (129/150) of cases. Conclusions: This SR demonstrates a current lack of high-quality evidence required to draw firm conclusions on the merits of arthroscopic versus open repair of 1B TFCC tears. There is no scientific evidence to suggest superiority of one technique over the other, albeit some surgeons and authors may express a strong personal view.

The outcome of bone graft surgery for nonunion of fractures of the scaphoid.

Data on 806 patients undergoing bone graft surgery for a scaphoid fracture nonunion were retrospectively collected at 19 centres in the United Kingdom. Each centre contributed at least 30 cases. Sufficient data were available in 462 cases to study factors that influenced the outcome of surgery. Overall union occurred in at least 69%, and nonunion in at least 22%, with 9% of cases having 'uncertain union status'. Union appeared to be adversely influenced by smoking and the time between acute scaphoid fracture and nonunion surgery, with adjusted odds ratios of 1.8 and 2.4, respectively, but neither achieved the pre-determined significance level of 0.003. The type of bone graft (vascular vs non-vascular; iliac crest vs distal radius) did not appear to influence outcome. Further large multicentre prospective studies with clear definitions of 'union' and other factors are needed to clarify whether modification of surgical technique can influence union. Level of evidence: IV.

Perceptions and experiences of wrist surgeons on the management of triangular fibrocartilage complex tears: a qualitative study.

There is lack of consensus on the management of triangular fibrocartilage injuries. The aim of this study was to investigate wrist surgeons' experiences and perceptions regarding treatment of triangular fibrocartilage complex injuries and to explore the rationale behind clinical decision-making. A purposive sample of consultant wrist surgeons (n = 10) was recruited through 'snow-balling' until data saturation was reached. Semi-structured interviews were conducted, digitally recorded and transcribed verbatim. Two researchers independently analysed data using an iterative/thematic approach. Findings suggest that surgeons rely more on their own training and experience, and patient-related factors such as individual expectations, to inform their decision-making, rather than on published material. Current classification systems are largely considered to be unhelpful. Level of evidence: V.

Interventions for treating wrist fractures in children.

BACKGROUND: Wrist fractures, involving the distal radius, are the most common fractures in children. Most are buckle fractures, which are stable fractures, unlike greenstick and other usually displaced fractures. There is considerable variation in practice, such as the extent of immobilisation for buckle fractures and use of surgery for seriously displaced fractures. OBJECTIVES: To assess the effects (benefits and harms) of interventions for common distal radius fractures in children, including skeletally immature adolescents. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group's Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, trial registries and reference lists to May 2018. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs comparing interventions for treating distal radius fractures in children. We sought data on physical function, treatment failure, adverse events, time to return to normal activities (recovery time), wrist pain, and child (and parent) satisfaction. DATA COLLECTION AND ANALYSIS: At least two review authors independently performed study screening and selection, 'Risk of bias' assessment and data extraction. We pooled data where appropriate and used GRADE for assessing the quality of evidence for each outcome. MAIN RESULTS: Of the 30 included studies, 21 were RCTs, seven were quasi-RCTs and two did not describe their randomisation method. Overall, 2930 children were recruited. Typically, trials included more male children and reported mean ages between 8 and 10 years. Eight studies recruited buckle fractures, five recruited buckle and other stable fractures, three recruited minimally displaced fractures and 14 recruited displaced fractures, typically requiring closed reduction, typically requiring closed reduction. All studies were at high risk of bias, mainly reflecting lack of blinding. The studies made 14 comparisons. Below we consider five prespecified comparisons:Removable splint versus below-elbow cast for predominantly buckle fractures (6 studies, 695 children)One study (66 children) reported similar Modified Activities Scale for Kids - Performance scores (0 to 100; no disability) at four weeks (median scores: splint 99.04; cast 99.11); low-quality evidence. Thirteen children needed a change or reapplication of device (splint 5/225; cast 8/219; 4 studies); very low-quality evidence. One study (87 children) reported no refractures at six months. One study (50 children) found no between-group difference in pain during treatment; very low-quality evidence. Evidence was absent (recovery time), insufficient (children with minor complications) or contradictory (child or parent satisfaction). Two studies estimated lower healthcare costs for removable splints.Soft or elasticated bandage versus below-elbow cast for buckle or similar fractures (4 studies, 273 children)One study (53 children) reported more children had no or only limited disability at four weeks in the bandage group; very low-quality evidence. Eight children changed device or extended immobilisation for delayed union (bandage 5/90; cast 3/91; 3 studies); very low-quality evidence. Two studies (139 children) reported no serious adverse events at four weeks. Evidence was absent, insufficient or contradictory for recovery time, wrist pain, children with minor complications, and child and parent satisfaction. More bandage-group participants found their treatment convenient (39 children).Removal of casts at home by parents versus at the hospital fracture clinic by clinicians (2 studies, 404 children, mainly buckle fractures)One study (233 children) found full restoration of physical function at four weeks; low-quality evidence. There were five treatment changes (home 4/197; hospital 1/200; 2 studies; very low-quality evidence). One study found no serious adverse effects at six months (288 children). Recovery time and number of children with minor complications were not reported. There was no evidence of a difference in pain at four weeks (233 children); low-quality evidence. One study (80 children) found greater parental satisfaction in the home group; low-quality evidence. One UK study found lower healthcare costs for home removal.Below-elbow versus above-elbow casts for displaced or unstable both-bone fractures (4 studies, 399 children)Short-term physical function data were unavailable but very low-quality evidence indicated less dependency when using below-elbow casts. One study (66 children with minimally displaced both-bone fractures) found little difference in ABILHAND-Kids scores (0 to 42; no problems) (mean scores: below-elbow 40.7; above-elbow 41.8); very low-quality evidence. Overall treatment failure data are unavailable, but nine of the 11 remanipulations or secondary reductions (366 children, 4 studies) were in the above-elbow group; very low-quality evidence. There was no refracture or compartment syndrome at six months (215 children; 2 studies). Recovery time and overall numbers of children with minor complications were not reported. There was little difference in requiring physiotherapy for stiffness (179 children, 2 studies); very low-quality evidence. One study (85 children) found less pain at one week for below-elbow casts; low-quality evidence. One study found treatment with an above-elbow cast cost three times more in Nepal.Surgical fixation with percutaneous wiring and cast immobilisation versus cast immobilisation alone after closed reduction of displaced fractures (5 studies, 323 children)Where reported, above-elbow casts were used. Short-term functional outcome data were unavailable. One study (123 children) reported similar ABILHAND-Kids scores indicating normal physical function at six months (mean scores: surgery 41.9; cast only 41.4); low-quality evidence. There were fewer treatment failures, defined as early or problematic removal of wires or remanipulation for early loss in position, after surgery (surgery 20/124; cast only 41/129; 4 studies; very low-quality evidence). Similarly, there were fewer serious advents after surgery (surgery 28/124; cast only 43/129; 4 studies; very low-quality evidence). Recovery time, wrist pain, and satisfaction were not reported. There was lower referral for physiotherapy for stiffness after surgery (1 study); very low-quality evidence. One USA study found similar treatment costs in both groups. AUTHORS' CONCLUSIONS: Where available, the quality of the RCT-based evidence on interventions for treating wrist fractures in children is low or very low. However, there is reassuring evidence of a full return to previous function with no serious adverse events, including refracture, for correctly-diagnosed buckle fractures, whatever the treatment used. The review findings are consistent with the move away from cast immobilisation for these injuries. High-quality evidence is needed to address key treatment uncertainties; notably, some priority topics are already being tested in ongoing multicentre trials, such as FORCE.

Registration and Outcome-Reporting Bias in Randomized Controlled Trials of Distal Radial Fracture Treatment.

BACKGROUND: The purpose of the present study was to systematically evaluate the completeness of trial registration and the extent of outcome-reporting bias in modern randomized controlled trials (RCTs) relating to the treatment of distal radial fracture. METHODS: With use of 4 databases (PubMed, Cochrane CENTRAL, Embase, and PEDro), this systematic review identified all RCTs of distal radial fracture treatment published from January 1, 2010, to December 31, 2015. We independently determined the registration status of these trials in a public trial registry and compared the characteristics of registered and non-registered trials. We assessed the quality and consistency of primary outcome measure (POM) reporting between the registration data and the final published studies. RESULTS: Ninety studies met the inclusion criteria. Of those, only 28 (31%) were registered, and only 3 (3%) were "appropriately registered" (i.e., prospectively registered and identifying and fully describing the POM). Registered trials had larger sample sizes and were more likely to be multicenter, to report funding sources, and to be published in higher-impact-factor journals. Sixteen (18%) of the 90 registered RCTs named a POM in the registry; 7 (44%) of those 16 registered RCTs stated a different POM, an additional POM, or no POM at all in the final publication than was stated in the registry data. Additionally, 13 (81%) of those 16 registered RCTs had discrepancies in the time point reported for the POM. CONCLUSIONS: In an attempt to address publication and outcome-reporting bias, prospective trial registration in a public registry has been deemed a condition for publication by the International Committee of Medical Journal Editors (ICMJE) since 2005. This study shows poor registration rates as well as inconsistencies in the reporting of POMs of recent trials relating to the treatment of distal radial fracture, one of the most common and most investigated injuries in orthopaedic practice. CLINICAL RELEVANCE: The problems of registration and outcome-reporting bias in RCTs are important to highlight and address, and to find a solution will require the cooperation of researchers, reviewers, and journal editors. Increasing the transparency and consistency of reporting will help to increase the quality of research, which can impact patient care through evidence-based guidelines.

A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): study protocol for a randomised controlled trial.

BACKGROUND: Dupuytren's contractures are fibrous cords under the skin of the palm of the hand. The contractures are painless but cause one or more fingers to curl into the palm, resulting in loss of function. Standard treatment within the NHS is surgery to remove (fasciectomy) or divide (fasciotomy) the contractures, and the treatment offered is frequently determined by surgeon preference. This study aims to determine the feasibility of conducting a large, multicentre randomised controlled trial to assess the clinical and cost-effectiveness of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contracture. METHODS/DESIGN: HAND-1 is a parallel, two-arm, multicentre, randomised feasibility trial. Eligible patients aged 18 years or over who have one or more fingers with a Dupuytren's contracture of more than 30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints, well-defined cord(s) causing contracture, and have not undergone previous surgery for Dupuytren's on the same hand will be randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy. Participants will be followed-up for up to 6 months post surgery. Feasibility outcomes include number of patients screened, consented and randomised, adherence with treatment, completion of follow-up and identification of an appropriate patient-reported outcome measure (PROM) to use as primary outcome for a main trial. Embedded qualitative research, incorporating a QuinteT Recruitment Intervention, will focus on understanding and optimising the recruitment process, and exploring patients' experiences of trial participation and the interventions. DISCUSSION: This study will assess whether a large multicentre trial comparing the clinical and cost-effectiveness of needle fasciotomy and limited fasciectomy for the treatment of Dupuytren's contractures is feasible, and if so will provide data to inform its design and successful conduct. TRIAL REGISTRATION: International Standard Registered Clinical/soCial sTudy Number: ISRCTN11164292 . Registered on 28 August 2015.

Surgical treatment of distal radial fractures with a volar locking plate versus conventional percutaneous methods: a randomized controlled trial.

BACKGROUND: The aim of this study was to compare the outcomes of displaced distal radial fractures treated with a volar locking plate with the results of such fractures treated with a conventional method of closed reduction and percutaneous wire fixation with supplemental bridging external fixation when required. Our aim was to ascertain whether the use of a volar locking plate improves functional outcomes. METHODS: A single-center, pragmatic, randomized controlled trial was conducted in a tertiary care institution. One hundred and thirty patients (eighteen to seventy-three years of age) who had a displaced distal radial fracture were randomized to treatment with either a volar locking plate (n = 66) or a conventional percutaneous fixation method (n = 64). Outcome assessments were conducted at six weeks, twelve weeks, and one year. Outcomes were measured on the basis of scores on the Patient Evaluation Measure (PEM) and QuickDASH questionnaire (a shortened version of the Disabilities of the Arm, Shoulder and Hand, or DASH, Outcome Measure), EuroQol-5D (EQ-5D) scores, wrist range of motion, grip strength, and radiographic parameters. RESULTS: The rate of follow-up at one year was 95%. Patients in the volar locking-plate group had significantly better PEM and QuickDASH scores and range of motion at six weeks compared with patients in the conventional-treatment group, but there were no significant differences between the two groups at twelve weeks or one year. Grip strength was better in the plate group at all time points. The volar locking plate was better at restoring palmar tilt and radial height. Significantly more patients in the plate group were driving at the end of six weeks, but this did not translate to a significant difference between groups in terms of those returning to work by that time. CONCLUSIONS: Use of a volar locking plate resulted in a faster early recovery of function compared with use of conventional methods. However, no functional advantage was demonstrated at or beyond twelve weeks. Use of the volar locking plate resulted in better anatomical reduction and grip strength, but there was no significant difference in function between the groups at twelve weeks or one year. The earlier recovery of function may be of advantage to some patients. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.