Explore the vast range of titles available.

IntroductionInjury to triangular fibrocartilage complex (TFCC) is a common cause of ulnar-sided wrist pain, of which peripheral TFCC tears are amenable to repair. The surgical approaches to treat TFCC tears are well-established, with arthroscopic or arthroscopic-assisted repair as the preferred method. However, the postoperative rehabilitation protocols significantly vary across different studies, ranging from 2 to 9 weeks, often without sufficient justification.Methods and analysisThis research is designed to conduct a randomised controlled trial at a single centre with double-blinding to compare the clinical and functional results of two immobilisation protocols of 3 weeks and 6 weeks, following arthroscopic repair of peripheral TFCC tears (ie, Palmar 1B, 1C and 1D) in adults, considering the phase of ligament healing. The hypothesis that there will be no significant difference in outcomes between the two groups is considered. Adults aged 18–60 years of both genders who present with ulnar-sided wrist pain and satisfy the inclusion criteria are included in the study. Following the arthroscopic TFCC repair using the Polydioxanone Suture (PDS) inside-out suture technique, the patients will be immobilised in an above-elbow cast according to their assigned immobilisation groups, which will be determined by a computer-generated 1:1 block randomisation. In this study, each group will have at least 16 participants. The primary outcomes will be evaluated by the weight-bearing press test and the ballottement test. Secondary outcomes, including the Visual Analogue Scale (VAS) score, grip strength, pinch strength, foveal sign, Modified Mayo Wrist Score (MMWS), patient-rated wrist/hand evaluation (PRWHE) score and the range of movements in the wrist and forearm, will be assessed and compared across the groups at each point of assessment, with the results subsequently reported in a detailed manner. The study will be reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines.Ethics and disseminationThe Ethics Committee of Kasturba Medical College, Manipal, approved the trial (approval No. IEC1 - 386). The data from this trial will be presented at academic conferences and published in peer-reviewed international journals.Trial registration numberThis trial has been registered at the Clinical Trial Registry of India (registration number: CTRI/2023/03/050692).

Background Scaphoid fractures are the most common carpal fractures. They often need to be treated by surgery, where the use of a compression screw is the globally accepted gold standard. Surgeons may choose between different implant materials including titanium alloys, which remain in the body or are removed after healing. An alternative are biodegradable magnesium-based implants. Properties of magnesium alloys include high stability, osteoconductivity, potential reduction of infections and few artifacts in magnetic resonance imaging (MRI). The aim of this trial is to demonstrate non-inferiority of magnesium-based compression screws compared with titanium Herbert screws for scaphoid fractures. Methods The trial is designed as a multicenter, blinded observer, randomized controlled parallel two-group post market trial. Approximately 190 patients will be randomized (1:1) with stratification by center either to titanium or magnesium-based compression screws. Follow-up is 1 year per patient. Surgical procedures and aftercare will be performed according to the German treatment guideline for scaphoid fractures. The first primary endpoint is the patient-rated wrist evaluation (PRWE) score after 6 months. The second primary endpoint is a composite safety endpoint including bone union until 6 months, no adverse device effect (ADE) during surgery or wound healing and no serious ADE or reoperation within 1 year. The third primary endpoint is the difference in change MRI artifacts over time. Non-inferiority will be investigated for primary endpoints 1 (t-test confidence interval) and 2 (Wilson’s score interval) using both the full analysis set (FAS) and the per protocol population at the one-sided 2.5% test-level. Superiority of magnesium over titanium screws will be established using the FAS at the two-sided 5% test-level (Welch test) only if non-inferiority has been established for both primary endpoints. Secondary endpoints include quality of life. Discussion This study will inform care providers whether biodegradable magnesium-based implants are non-inferior to standard titanium Herbert screws for the treatment of scaphoid fractures in terms of wrist function and safety. Furthermore, superiority of magnesium-based implants may be demonstrated using MRI, which is used as surrogate endpoint for screw degradation. Trial registration DRKS, DRKS00013368 . Registered Dec 04, 2017.

Distal radius fractures (DRFs) are common injuries among older adults and can result in substantial disability. Current evidence regarding long-term outcomes in older adults is scarce. To compare outcomes across treatment groups at 24 months among adults with DRFs who participated in the WRIST trial. The Wrist and Radius Injury Surgical Trial (WRIST) randomized, international, multicenter trial was conducted from April 1, 2012, through December 31, 2016. Participants were adults aged 60 years or older with isolated, unstable DRFs at 24 health systems in the US, Canada, and Singapore. Data analysis was performed from March 2019 to March 2021. Participants were randomized to open reduction and volar locking plate system (VLPS), external fixation with or without supplementary pinning (EFP), and percutaneous pinning (CRPP). The remaining participants chose closed reduction and casting. The primary outcome was the 24-month Michigan Hand Outcomes Questionnaire (MHQ) summary score. Secondary outcomes were scores on the MHQ subdomains hand strength and wrist motion. A total of 304 adults were recruited for the study, and 187 were randomized to undergo surgery, 65 to VLPS, 64 to EFP, and 58 to CRPP; 117 participants opted for closed reduction and casting. Assessments were completed at 24 months for 182 participants (160 women [87.9%]; mean [SD] age, 70.1 [8.5] years). Mean MHQ summary scores at 24 months were 88 (95% CI, 83-92) for VLPS, 83 (95% CI, 78-88) for EFP, 85 (95% CI, 79-90) for CRPP, and 85 (95% CI, 79-90) for casting, with no clinically meaningful difference across groups after adjusting for covariates (χ23 = 1.44; P = .70). Pain scores also did not differ across groups at 24 months (χ23 = 2.64; P = .45). MHQ summary scores changed from 82 (95% CI, 80-85) to 85 (95% CI, 83-88) (P = .12) between 12 and 24 months across groups. The rate of malunion was higher in the casting group (26 participants [59.1%]) than in the other groups (4 participants [8.0%] for VLPS, 8 participants [17.0%] for EFP, and 4 participants [9.8%] for CRPP; χ23 = 43.6; P < .001), but malunion was not associated with the 24-month outcome difference across groups. The study did not find clinically meaningful patient-reported outcome differences 24 months after injury across treatment groups, with little change between 12 and 24 months. These findings suggest that long-term outcomes need not necessarily be considered in deciding between treatment options. Patient needs and recovery goals that fit to relative risks and benefits of each treatment type will be more valuable in treatment decision-making. ClinicalTrials.gov Identifier: NCT01589692.

Background A scaphoid fracture is the most common type of carpal fracture affecting young active people. The optimal management of this fracture is uncertain. When treated with a cast, 88 to 90 % of these fractures unite; however, for the remaining 10-12 % the non-union almost invariably leads to arthritis. The alternative is surgery to fix the scaphoid with a screw at the outset. Methods/Design We will conduct a randomised controlled trial (RCT) of 438 adult patients with a “clear” and “bicortical” scaphoid waist fracture on plain radiographs to evaluate the clinical effectiveness and cost-effectiveness of plaster cast treatment (with fixation of those that fail to unite) versus early surgical fixation. The plaster cast treatment will be immobilisation in a below elbow cast for 6 to 10 weeks followed by mobilisation. If non-union is confirmed on plain radiographs and/or Computerised Tomogram at 6 to 12 weeks, then urgent surgical fixation will be performed. This is being compared with immediate surgical fixation with surgeons using their preferred technique and implant. These treatments will be undertaken in trauma units across the United Kingdom. The primary outcome and end-point will be the Patient Rated Wrist Evaluation (a patient self-reported assessment of wrist pain and function) at 52 weeks and also measured at 6, 12, 26 weeks and 5 years. Secondary outcomes include an assessment of radiological union of the fracture; quality of life; recovery of wrist range and strength; and complications. We will also qualitatively investigate patient experiences of their treatment. Discussion Scaphoid fractures are an important public health problem as they predominantly affect young active individuals in the more productive working years of their lives. Non-union, if untreated, can lead to arthritis which can disable patients at a very young age. There is a rapidly increasing trend for immediate surgical fixation of these fractures but there is insufficient evidence from existing RCTs to support this. The SWIFFT Trial is a rigorously designed and adequately powered study which aims to contribute to the evidence-base to inform clinical decisions for the treatment of this common fracture in adults. Trial registration The trial is registered with the International Standard Randomised Controlled Trial Register ( ISRCTN67901257 ). Date registration assigned was 13/02/2013.

Introduction We aimed to evaluate the influence of associated scapholunate (SL) and/or lunotriquetral ligament (LT) injury on the outcome of distal radius fractures. Materials and methods This prospective study included 40 patients with surgically treated distal radius fracture. Wrist arthroscopy was used to identify associated lesions of the scapholunate and lunotriquetral ligaments and classify them according to Geissler. Patients were divided in two groups by presence (injured group) or absence (intact group) of associated injury of the SL and/or LT ligament. The patient-rated wrist evaluation (PRWE) and the disabilities of the arm, shoulder and hand (DASH) questionnaires were used to evaluate disability 3 and 6 months after injury. Grip strength was also evaluated. Results Wrist arthroscopy identified SL and/or LT injury in 15 patients (37.5 %). Mean total PRWE score for the intact group was 26.64 at 3 months and 16.22 at 6 months, and 50.47 (at 3 months) and 20.7 (at 6 months) for the group with ligament injury. Mean DASH scores were 26.03 and 13 at 3 and 6 months for the intact group, and 49.5 and 24.11 for the injured group. Mann–Whitney test results showed significant difference for the PRWE and DASH scores and the grip strength for the two examined groups. Conclusions Patients with distal radius fracture with associated intrinsic ligament injury had worse outcomes than did patients without associated ligamentous injury. Associated injuries of the SL and LT ligament should be considered when treating distal radius fractures, and wrist arthroscopy should be incorporated into the operative protocol.

Background Distal radial fractures are one of the most common orthopaedic cases that present to the A&E department. Surgical intervention is warranted in displaced intraarticular fractures and fractures with more than the recommended angulation or shortening, and is most commonly treated with volarly placed fixed angle locking plates. The aim of this study is to determine and compare the efficacy of two different plates for surgical treatment of distal radius fractures. The VRP 2.0 is a new plate produced by the Austofix company and this system will be compared against the VA-LP (Variable angle-locking plate) produced by Depuy-Synthes which has been used as the standard treatment device. Methods and Design Patients between the ages of 18 and 80 presenting to the Royal Adelaide Hospital with isolated closed distal radial fractures will be invited to participate in this study. A total of 200 patients are required to provide 90% statistical power at a 5% alpha level to detect a difference of 11.5 points on the PRWE (Patient rated Wrist evaluation) score. The primary outcome measure will be the PRWE score while the secondary outcome measures will include the DASH score, EQ5D score, clinical range of movements, grip strength as well as patient perceived return of function at the wrist and time to resumption to work. These will be measured at 6 weeks, 3 months and 12 months. Radiographic indices including the radial tilt, length, volar inclination and plate prominence will also be measured. Complications will be recorded up to 12 months. Post hoc comparisons will be done using paired t tests. An intention to treat and a per protocol analysis will be done to compare the 2 groups. Discussion Distal radial fractures are increasingly being treated by internal fixation using volar locking plates. However, there is no prospective study to date comparing one plate against another in terms of outcome and complications. This study could provide more information about the best way to treat these injuries surgically. Trial registration The trial is registered with the Australia New Zealand Clinical Trials Registry (ANZCTR). Trial registration date-17/11/2016. Trial registration number- ACTRN12616001590459 .

The purpose of this study was to determine the rate of cast-related complications when using split or intact casts. A total of 60 patients aged 3 to 13 years with closed shaft or distal third radius and ulna fractures requiring reduction were recruited for this study. Patients underwent closed reduction under sedation and were placed into a long-arm fiberglass cast with 1 of 3 modifications: no valve, univalve, or bivalve. Patients were followed to 6 weeks after reduction or surgical treatment if required. The frequency of neurovascular injury, cast saw injury, unplanned office visits, and cast modifications, the need for operative intervention, and pain levels through the follow-up period were recorded. The results showed no incidents of compartment syndrome or neurovascular injury. Additionally, there were no differences between complications associated with cast type ( P =.266), frequency of cast modifications ( P =.185), or subsequent need for surgical stabilization ( P =.361). Therefore, cast splitting following closed reduction of low-energy pediatric forearm fractures does not change clinical outcomes with respect to neurovascular complications, cast modifications, pain levels, or the need for repeat reduction. Consideration should be given to minimizing cast splitting after reduction of low-energy pediatric forearm fractures for practice efficiency and to potentially decrease saw-related injury. [ Orthopedics. 2017; 40(5):e849–e854.]

Despite appropriate treatment, many patients who sustain distal radius fractures (DRFs) report persistent wrist pain. Chronic musculoskeletal pain is among the leading health problems in the elderly population associated with significant personal and societal burden. To identify modifiable preoperative factors that are significantly associated with developing chronic pain. This is a secondary analysis of the Wrist and Radius Injury Surgical Trial (WRIST), a randomized multicenter clinical trial of 24 study sites in the United States, Canada, and Singapore that enrolled patients from April 10, 2012, to December 31, 2016. Adults older than 60 years who sustained closed extra-articular DRFs, were treated operatively, and completed 12-month Michigan Hand Outcomes Questionnaires (MHQs) were included in this study. Analysis was conducted from September to December 2019. Volar locking plate internal fixation, external fixation, or percutaneous pinning. 12-month MHQ pain domain score. Inverse probability weighted logistic regression was used to identify factors associated with of chronic pain. A total of 146 patients with DRF who were treated operatively and had 12-month MHQ scores met inclusion criteria. The mean (SD) patient age was 68.9 (7.2) years, 128 (87.6%) were women, and 93 (63.7%) were retired. Chronic pain was present in 87 patients (59.6%) and absent in 59 patients (40.4%) at 1-year follow-up. A 1-week delay in surgery was associated with more than triple the odds of developing chronic pain (odds ratio [OR], 3.65; 95% CI, 1.48-9.00), and each 10-point increase in preoperative pain was associated with a 17% increase in the odds of experiencing chronic pain (OR, 1.17; 95% CI, 1.02-1.34). Internal fixation was associated with decreased odds of developing chronic pain compared with the other 2 procedures (OR, 0.29; 95% CI, 0.10-0.90). In this study, preoperative pain, time to surgery, and procedure type were modifiable factors associated with chronic pain 1 year after DRF treated with surgery. Adequate pain control in patients with acute DRFs even before definitive surgical management and earlier fixation for patients requiring surgery may decrease the risk of developing chronic pain. Internal fixation may decrease the risk of chronic pain after DRF surgery, compared with percutaneous pinning or external fixation. ClinicalTrials.gov Identifier: NCT01589692.

Background Approximately 17 % of all fractures involve the distal radius. Two-thirds require reduction due to displacement. High redislocation rates and functional disability remain a significant problem after non-operative treatment, with up to 30 % of patients suffering long-term functional restrictions. Whether operative correction is superior to non-operative treatment with respect to functional outcome has not unequivocally been confirmed. The IlluminOss® System was introduced in 2009 as a novel, patient-specific, and minimally invasive intramedullary fracture fixation. This minimally invasive technique has a much lower risk of iatrogenic soft tissue complications. Because IlluminOss® allows for early mobilization, it may theoretically lead to earlier functional recovery and ADL independence than non-operative immobilization. The main aim of this study is to examine outcome in elderly patients who sustained a unilateral, displaced, extra-articular distal radius fracture that was treated with IlluminOss®. Methods/design The design of the study will be a multicenter, prospective, observational study (case series). The study population comprises elderly (60 years or older; independent in activities of daily living) with a unilateral, displaced, extra-articular distal radius fracture (AO/OTA type 23-A2 and A3) that after successful closed reduction was fixed within 2 weeks after the injury with IlluminOss®. Critical elements of treatment will be registered, and outcome will be monitored until 1 year after surgery. The Disabilities of the Arm, Shoulder, and Hand score will serve as primary outcome measure. The Patient-Rated Wrist Evaluation score, level of pain, health-related quality of life (Short Form-36 and EuroQoL-5D), time to ADL independence, time to activities/work resumption, range of motion of the wrist, radiological outcome, and complications are secondary outcome measures. Health care consumption and lost productivity will be used for a cost analysis. The cost analysis will be performed from a societal perspective. Descriptive data will be reported. Discussion The results of this study will provide evidence on the effectiveness of operative treatment of patients who sustained an extra-articular distal radius fracture with the IlluminOss® System, using clinical, patient-reported, and societal outcomes. Trial registration The study is registered at the Netherlands Trial Register ( NTR5457 ; 29-sep-2015).