Fractures of the distal radius: does operative treatment with a volar locking plate improve outcome?: a randomised controlled trial

Background and aims The advent of volar locking plates designed specifically for fractures of the distal radius has resulted in a major shift away from percutaneous fixation of these injuries. However, comparative studies have not always demonstrated better outcomes than those achieved with less invasive and potentially less expensive established techniques. The present study was a randomized controlled trial comparing the outcome of displaced distal radius fractures when treated with a volar locking plate or closed reduction and percutaneous wire fixation, with supplemental bridging external fixation when required. The primary research objective was to ascertain whether the use of volar locking plates improves functional outcome in the short and medium term. The secondary objective was to determine, through economic evaluation, whether the use of volar locking plates for distal radius fractures is of financial benefit to the health service. Methods A single-centre randomized controlled trial of pragmatic design, conducted in a tertiary care institution, with accompanying economic evaluation. 130 patients with displaced distal radius fractures were randomised to either volar locking plate (n=66) or conventional percutaneous fixation methods (n=64). Outcome assessments were conducted at 6 weeks, 12 weeks and 1 year. The primary outcome measure was the PEM score at one year. Secondary outcomes included the QuickDASH, PRWE, EQ-5D and SF-12 scores, range of motion, grip strength, radiographic and cost parameters. A cost-effectiveness analysis was performed from the perspective of the NHS, and in line with NICE guidance on the methods of technology appraisal. “Bottom up” micro-costing methods were used to calculate costs for each treatment pathway, prospectively collecting information on consumables, inpatient and outpatient resource use, complications and additional procedures up to a year post surgery. Main findings Patients in the volar locking plate group had significantly better PEM, QuickDASH, PRWE scores and range of motion at 6 weeks, with no differences at 12 weeks and 1 year. Grip strength was better for the plate group at all time points. The volar locking plate was better at restoring the radiographic parameters of palmar tilt and radial height. Despite the early functional advantage, patients did not return to work sooner. Quality of life scores were marginally, but not significantly, better for the plate group at early follow-up. Both groups returned to baseline at one year. NHS costs for the plate group were significantly higher. For an additional £713, VLP fixation offered 0.018 additional QALYs in the year post surgery. The incremental cost effectiveness ratio (ICER) for VLP fixation at NHS list price was £40,068. Conclusion The current study showed that use of a volar locking plate resulted in better early post-operative function. However, there was no significant difference at, or after 12 weeks. The volar locking plate achieved better radiographic reduction and measured grip strength, but this did not translate to a difference in function at 12 weeks and 1 year. The earlier recovery of function may be of advantage to some patients. However, in spite of their increasing use and popularity, volar locking plates were cost-ineffective according to NICE threshold criteria

Fractures of the distal radius: does operative treatment with a volar locking plate improve outcome?: a randomised controlled trial

Background and aims The advent of volar locking plates designed specifically for fractures of the distal radius has resulted in a major shift away from percutaneous fixation of these injuries. However, comparative studies have not always demonstrated better outcomes than those achieved with less invasive and potentially less expensive established techniques. The present study was a randomized controlled trial comparing the outcome of displaced distal radius fractures when treated with a volar locking plate or closed reduction and percutaneous wire fixation, with supplemental bridging external fixation when required. The primary research objective was to ascertain whether the use of volar locking plates improves functional outcome in the short and medium term. The secondary objective was to determine, through economic evaluation, whether the use of volar locking plates for distal radius fractures is of financial benefit to the health service. Methods A single-centre randomized controlled trial of pragmatic design, conducted in a tertiary care institution, with accompanying economic evaluation. 130 patients with displaced distal radius fractures were randomised to either volar locking plate (n=66) or conventional percutaneous fixation methods (n=64). Outcome assessments were conducted at 6 weeks, 12 weeks and 1 year. The primary outcome measure was the PEM score at one year. Secondary outcomes included the QuickDASH, PRWE, EQ-5D and SF-12 scores, range of motion, grip strength, radiographic and cost parameters. A cost-effectiveness analysis was performed from the perspective of the NHS, and in line with NICE guidance on the methods of technology appraisal. “Bottom up” micro-costing methods were used to calculate costs for each treatment pathway, prospectively collecting information on consumables, inpatient and outpatient resource use, complications and additional procedures up to a year post surgery. Main findings Patients in the volar locking plate group had significantly better PEM, QuickDASH, PRWE scores and range of motion at 6 weeks, with no differences at 12 weeks and 1 year. Grip strength was better for the plate group at all time points. The volar locking plate was better at restoring the radiographic parameters of palmar tilt and radial height. Despite the early functional advantage, patients did not return to work sooner. Quality of life scores were marginally, but not significantly, better for the plate group at early follow-up. Both groups returned to baseline at one year. NHS costs for the plate group were significantly higher. For an additional £713, VLP fixation offered 0.018 additional QALYs in the year post surgery. The incremental cost effectiveness ratio (ICER) for VLP fixation at NHS list price was £40,068. Conclusion The current study showed that use of a volar locking plate resulted in better early post-operative function. However, there was no significant difference at, or after 12 weeks. The volar locking plate achieved better radiographic reduction and measured grip strength, but this did not translate to a difference in function at 12 weeks and 1 year. The earlier recovery of function may be of advantage to some patients. However, in spite of their increasing use and popularity, volar locking plates were cost-ineffective according to NICE threshold criteria

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, rather than on published material, to inform their decision-making. Current classification systems are largely considered to be unhelpful

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 (RCT) 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 much wider breadth of common hand injuries

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

Background Hand fractures and joint injuries are common, with significant impact for patients themselves but also on a wider societal and economic level through healthcare costs and productivity loss. Despite the clear significance of these injuries, there is not a consensus on optimal treatment. The variety of treatment options together with a lack of consistency in outcome reporting and research method standards makes interpretation of the available evidence challenging. One solution is a core outcome set, which aims to set the minimum outcome measurements in any clinical study. This would improve consistency and comparability between studies, facilitating meta-analysis. Aim The overarching aim was to work towards development of a core outcome set for hand fractures and joint injuries in adults which will guide outcome assessment in future studies. The primary purpose of this project was to establish ‘what’ should be measured when considering the outcome of hand fracture and joint injury management. Methods This was a mixed methods study to develop a core outcome set for clinical trials of hand fractures and joint injuries, with initial scoping work to clarify the set of injuries intended to be covered by the core outcome set, analysis of data from a UK Major Trauma Centre to determine a sense of the scale of the incidence of hand fractures, and then phases of outcome domain generation and consensus prioritisation to reach the final core outcome set. The specific steps were: • Defining the scope of injuries to be addressed by the core outcome set through one-to- one discussions with expert stakeholder consultation with hand surgeons and therapists • Collecting data from reports of all hand and wrist radiographs from Queen’s Medical Centre (Nottingham) over a one-year period to assess the incidence and anatomical distribution of fractures. • A systematic review of randomised/quasi-randomised controlled studies and large (≥100 participant) prospective observational studies on treatment of hand fractures and joint injuries to identify outcomes selected in recently published studies. An assessment of outcome reporting bias was also conducted • Extensive exploratory qualitative research with the patient stakeholder group, to identify their perspective on the injury, treatment and outcomes important to them and to generate outcome domains as well as descriptors using an inductive, thematic approach • Initial consensus prioritisation of a longlist of outcome domains developed through synthesis of the systematic review and qualitative work through an international three-round Delphi survey • A final consensus meeting using an adapted nominal group technique format, involving all key stakeholders, to reach consensus on a final core outcome set. Main findings In the systematic review of 160 studies vast heterogeneity in outcome selection was found. There were 639 unique outcomes, which were rationalised to 74 outcome domains based on the World Health Organization International Classification of Functioning, Disability, and Health framework. Outcome reporting bias was evident, with only a minority of outcomes appropriately reported across these studies. To explore which outcomes were relevant to patients with hand fractures and joint injuries, a qualitative study was conducted involving interviews (25 patients) and focus groups (five groups involving a total of 21 patients). A total of 35 outcome domains grouped within six broad themes were generated, along with descriptors for the domains. The two streams of outcome domains were synthesised to form a longlist of 37 domains that entered a consensus process beginning with an online international Delphi survey. From the original 152 participants who began the survey, 144 (>94%) completed all three rounds (54 patients, 55 hand surgeons, 35 hand therapists). Based on pre-defined consensus criteria, 20domains reached consensus as ‘very important’ and the remainder reached no consensus. All outcome domains were discussed at a final consensus meeting with 27 participants (12 patients, seven surgeons, six hand therapists, a health economist and a trial manager). The domains reaching no consensus were discussed and voted upon, with none reaching threshold to salvage and consider for the core outcome set. The 20 ‘consensus in’ domains were discussed and underwent iterative prioritisation steps. A final vote selected seven outcome domains for inclusion in the core outcome set: fine hand use, pain / discomfort at rest, pain / discomfort with activity, self-hygiene / personal care, return to usual work / job, range of movement, and patient satisfaction with outcome / result. Conclusion This study has shown the magnitude of the inconsistency in outcome selection for clinical research on hand fractures and joint injuries in adults. A core outcome set to help address this issue was developed based on exploration of the existing literature and the patient perspective. Through a subsequent systematic consensus process, the longlist of outcome domains was refined to a final set of seven core outcome domains. These touch upon several bases including functional tasks (covering basic aspects and a working life role), patient comfort, abstract function (range of motion) and patient satisfaction. They are recommended as the baseline domains to be measured in future clinical research on these injuries, with the optimum way to measure the domains being the subject of future work

Registration and outcome reporting bias in randomised controlled trials of distal radius fracture treatment: a systematic review

Background: The aim was to systematically evaluate the completeness of trial registration and the extent of outcome-reporting bias in modern randomised controlled trials (RCTs) of distal radius fracture treatment. This is the first study to investigate this in the setting of a single, common, well-researched orthopaedic injury and across all journal publications. Methods: Utilizing four databases (PubMed, Cochrane, Embase and PEDro), this systematic review identified all RCTs of distal radius fracture treatment published from January 2010 to December 2015. We independently determined the registration status of these trials in a public trial registry and compared characteristics of registered and non-registered trials. We assessed quality and consistency of primary outcome measure (POM) reporting between registration and final published reports. Results: Ninety studies fulfilled the inclusion criteria. Of the 90 RCTs, only 31% (28/90) were registered; 3% (3/90) were "appropriately registered" i.e. registered prospectively, identifying and fully describing the POM. Registered trials had larger sample sizes, were more likely to be multi-centre, to report funding sources and be published in higher impact factor journals. Of the 16 (18%, 16/90) registered RCTs which named a POM, seven (7/16, 44%) stated a different or additional POMs in the final publication, whereas 13 (13/16, 81%) had discrepancies in the time-point reported for the POM. Conclusion: 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, in an attempt to address publication and outcome-reporting bias. This study demonstrates poor registration rates and inconsistencies in the reporting of primary outcomes measures of recent trials of distal radius fracture treatment, one of the most common and most investigated injuries in orthopaedic practice. Clinical relevance: This problem is important to highlight and address with the cooperation of researchers, reviewers, journal editors and the scientific community as a whole. Increasing the transparency and consistency of reporting will help drive up the quality of distal radius fracture research, which increasingly impacts on patient care through evidence-based guidelines

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

Background Hand fractures and joint injuries are common, with significant impact for patients themselves but also on a wider societal and economic level through healthcare costs and productivity loss. Despite the clear significance of these injuries, there is not a consensus on optimal treatment. The variety of treatment options together with a lack of consistency in outcome reporting and research method standards makes interpretation of the available evidence challenging. One solution is a core outcome set, which aims to set the minimum outcome measurements in any clinical study. This would improve consistency and comparability between studies, facilitating meta-analysis. Aim The overarching aim was to work towards development of a core outcome set for hand fractures and joint injuries in adults which will guide outcome assessment in future studies. The primary purpose of this project was to establish ‘what’ should be measured when considering the outcome of hand fracture and joint injury management. Methods This was a mixed methods study to develop a core outcome set for clinical trials of hand fractures and joint injuries, with initial scoping work to clarify the set of injuries intended to be covered by the core outcome set, analysis of data from a UK Major Trauma Centre to determine a sense of the scale of the incidence of hand fractures, and then phases of outcome domain generation and consensus prioritisation to reach the final core outcome set. The specific steps were: • Defining the scope of injuries to be addressed by the core outcome set through one-to- one discussions with expert stakeholder consultation with hand surgeons and therapists • Collecting data from reports of all hand and wrist radiographs from Queen’s Medical Centre (Nottingham) over a one-year period to assess the incidence and anatomical distribution of fractures. • A systematic review of randomised/quasi-randomised controlled studies and large (≥100 participant) prospective observational studies on treatment of hand fractures and joint injuries to identify outcomes selected in recently published studies. An assessment of outcome reporting bias was also conducted • Extensive exploratory qualitative research with the patient stakeholder group, to identify their perspective on the injury, treatment and outcomes important to them and to generate outcome domains as well as descriptors using an inductive, thematic approach • Initial consensus prioritisation of a longlist of outcome domains developed through synthesis of the systematic review and qualitative work through an international three-round Delphi survey • A final consensus meeting using an adapted nominal group technique format, involving all key stakeholders, to reach consensus on a final core outcome set. Main findings In the systematic review of 160 studies vast heterogeneity in outcome selection was found. There were 639 unique outcomes, which were rationalised to 74 outcome domains based on the World Health Organization International Classification of Functioning, Disability, and Health framework. Outcome reporting bias was evident, with only a minority of outcomes appropriately reported across these studies. To explore which outcomes were relevant to patients with hand fractures and joint injuries, a qualitative study was conducted involving interviews (25 patients) and focus groups (five groups involving a total of 21 patients). A total of 35 outcome domains grouped within six broad themes were generated, along with descriptors for the domains. The two streams of outcome domains were synthesised to form a longlist of 37 domains that entered a consensus process beginning with an online international Delphi survey. From the original 152 participants who began the survey, 144 (>94%) completed all three rounds (54 patients, 55 hand surgeons, 35 hand therapists). Based on pre-defined consensus criteria, 20domains reached consensus as ‘very important’ and the remainder reached no consensus. All outcome domains were discussed at a final consensus meeting with 27 participants (12 patients, seven surgeons, six hand therapists, a health economist and a trial manager). The domains reaching no consensus were discussed and voted upon, with none reaching threshold to salvage and consider for the core outcome set. The 20 ‘consensus in’ domains were discussed and underwent iterative prioritisation steps. A final vote selected seven outcome domains for inclusion in the core outcome set: fine hand use, pain / discomfort at rest, pain / discomfort with activity, self-hygiene / personal care, return to usual work / job, range of movement, and patient satisfaction with outcome / result. Conclusion This study has shown the magnitude of the inconsistency in outcome selection for clinical research on hand fractures and joint injuries in adults. A core outcome set to help address this issue was developed based on exploration of the existing literature and the patient perspective. Through a subsequent systematic consensus process, the longlist of outcome domains was refined to a final set of seven core outcome domains. These touch upon several bases including functional tasks (covering basic aspects and a working life role), patient comfort, abstract function (range of motion) and patient satisfaction. They are recommended as the baseline domains to be measured in future clinical research on these injuries, with the optimum way to measure the domains being the subject of future work

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