Aims. To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Methods. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840

Introduction. Unstable ankle fractures are routinely managed operatively. Due to soft-tissue and implant related complications, there has been recent literature reporting on the non-operative management of well-reduced medial malleolus fractures following fibular stabilisation, but with limited evidence supporting routine application. This trial assessed the superiority of internal fixation of well-reduced (displacement ≤2mm) medial malleolus fractures compared with non-fixation following fibular stabilisation. Methods and participants. Superiority, pragmatic, parallel, prospective randomised clinical trial conducted over a four year period. A total of 154 adult patients with a bi- or trimalleolar fractures were recruited from a single centre. Open injuries and vertical medial malleolar fractures were excluded. Following fibular stabilisation, patients were randomised intra-operatively on a 1:1 basis to fixation or non-fixation after satisfactory fluoroscopic fracture reduction was confirmed. The primary outcome was the Olerud Molander Ankle Score (OMAS) at one-year post-randomisation. Complications and radiographic outcomes were documented over the follow-up period. Results. Among 154 participants (mean age, 56.5 years; 119 women [77%]), 144 [94%] completed the trial. At one-year the median OMAS was 80 (IQR, 60–90) in the fixation group compared with 72.5 (IQR, 55–90) in the non-fixation group (p=0.17). Complication rates were comparable. Significantly more patients in the non-fixation group developed a radiographic non-union (20% vs 0%; p<0.001), with the majority (n=8/13) clinically asymptomatic and one patient required surgical re-intervention for this. Fracture type and reduction quality appeared to influence fracture union and patient outcome. Conclusions. In this randomised clinical trial comparing internal fixation of well-reduced medial malleolus fractures with non-fixation, following fibular stabilisation, fixation was not superior according to the primary outcome. However, 1 in 5 patients following non-fixation developed a radiographic non-union and whilst the re-intervention rate to manage this was low, the future implications require surveillance. These results may support selective non-fixation of anatomically reduced medial malleolus fractures

Background

Talar neck fractures occur infrequently and are associated with high complication rates. Anatomical restoration of articular congruity is important. Adequate exposure and stable internal fixation of these fractures are challenging.

Patients with advanced stage hallux rigidus from 12 centers in Canada and the UK were randomized (2:1) to treatment with a small (8/10 mm) hydrogel implant (Cartiva) or 1^st MTP arthrodesis. VAS pain scale, validated outcome measures (FAAM sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment and safety parameters were evaluated.

236 patients were initially enrolled, 17 patients withdrew prior to randomization, 17 patients withdrew after randomization and 22 were non-randomized training patients, leaving 152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were similar for both groups.

Mean VAS pain scores decreased from 6.8 and 6.9 respectively for the implant and arthrodesis groups from baseline to 1.4 and 0.7 at 24 months. Similarly, the FAAM sports score improved significantly from baseline levels of 37 and 36 to 24 months level of 77 and 82 respectively for the implant and arthrodesis groups. First MTP active dorsiflexion motion improved an average of 4° at 3 months after implant placement and was maintained at 24 months.

Secondary surgeries occurred in 17 (11.2%) implant patients and 6 (12.0%) arthrodesis patients. Fourteen (9.2%) implants were removed and converted to arthrodesis and 6 (12.0%) arthrodesis patients had painful hardware requiring removal. There was no case of implant fragmentation, wear, or bone loss. Analysis of a single composite endpoint utilizing the three primary study outcomes (pain, function, and safety) showed statistical equivalence between the2groups.

Aims. The optimal management of posterior malleolar ankle fractures, a prevalent type of ankle trauma, is essential for improved prognosis. However, there remains a debate over the most effective surgical approach, particularly between screw and plate fixation methods. This study aims to investigate the differences in outcomes associated with these fixation techniques. Methods. We conducted a comprehensive review of clinical trials comparing anteroposterior (A-P) screws, posteroanterior (P-A) screws, and plate fixation. Two investigators validated the data sourced from multiple databases (MEDLINE, EMBASE, and Web of Science). Following PRISMA guidelines, we carried out a network meta-analysis (NMA) using visual analogue scale and American Orthopaedic Foot and Ankle Score (AOFAS) as primary outcomes. Secondary outcomes included range of motion limitations, radiological outcomes, and complication rates. Results. The NMA encompassed 13 studies, consisting of four randomized trials and eight retrospective ones. According to the surface under the cumulative ranking curve-based ranking, the A-P screw was ranked highest for improvements in AOFAS and exhibited lowest in infection and peroneal nerve injury incidence. The P-A screws, on the other hand, excelled in terms of VAS score improvements. Conversely, posterior buttress plate fixation showed the least incidence of osteoarthritis grade progression, postoperative articular step-off ≥ 2 mm, nonunions, and loss of ankle dorsiflexion ≥ 5°, though it underperformed in most other clinical outcomes. Conclusion. The NMA suggests that open plating is more likely to provide better radiological outcomes, while screw fixation may have a greater potential for superior functional and pain results. Nevertheless, clinicians should still consider the fragment size and fracture pattern, weighing the advantages of rigid biomechanical fixation against the possibility of soft-tissue damage, to optimize treatment results. Cite this article: Bone Jt Open 2024;5(3):227–235

Background. Infiltration is considered the first treatment option for symptomatic Morton's neuroma and can be performed with various medications. The aim of this study was to compare the effects of hyaluronic acid infiltration versus corticosteroid injection in the treatment of Morton's neuroma. Methods. A randomised clinical trial was conducted with 46 patients (50 feet) diagnosed with Morton's neuroma. After randomisation, the control group (CG) received three injections (one per week) of triamcinolone (Triancil®) guided by ultrasound, while the study group (SG) received three applications of hyaluronic acid (Osteonil Plus®). Patients were followed up for six months after the intervention. The primary outcome measure used was the Visual Pain Analog Scale (VAS). Secondary endpoints included patient-reported outcome measures using the American Orthopaedic Foot & Ankle Society (AOFAS) score and complications. Results. Both groups showed significant improvement in VAS and AOFAS scores (p < 0.001). The CG showed greater improvement than the SG in the VAS (p < 0.05) and AOFAS (p < 0.001) variables. Four patients in the CG experienced skin hypochromia at the injection site, while there were no complications in the SG. Conclusion. Ultrasound-guided hyaluronic acid infiltration in Morton's Neuroma proved to be safe, showing improvement in pain and function after six months of follow-up, without major complications, but with a significantly lower improvement when compared to corticosteroid injection. Taking into account cost implications and the potential for longer lasting improvement from viscosupplementation further medium- and long-term studies are needed

Background. Supination-external rotation (SER) injuries make up 80% of all ankle fractures. SER stage 2 injuries (AITFL and Weber B) are considered stable. SER stage 3 injury includes disruption of the posterior malleolus (or PITFL). In SER stage 4 there is either medial malleolus fracture or deltoid injury too. SER 4 injuries have been considered unstable, requiring surgery. The deltoid ligament is a key component of ankle stability, but clinical tests to assess deltoid injury have low specificity. This study specifically investigates the role of the components of the deep deltoid ligament in SER ankle fractures. Aim. To investigate the effect of deep deltoid ligament injury on SER ankle fracture stability. Methods. Four matched pairs (8 specimens) were tested using a standardised protocol. Specimens were sequentially tested for stability when axially loaded with a custom rig with up to 750N. Specimens were tested with: ankle intact; lateral injury (AITFL and Weber B); additional posterior injury (PITFL); additional anterior deep deltoid; additional posterior deep deltoid; lateral side ORIF. Clinical photographs and radiographs were recorded. In addition, dynamic stress radiographs were performed after sectioning the deep deltoid and then after fracture fixation to assess tilt of the talus in eversion. Results. All specimens with an intact posterior deep deltoid ligament were stable when loaded and showed no talar tilt on dynamic assessment. Once the posterior deep deltoid ligament was sectioned there was instability in all specimens. Surgical stabilisation of the lateral side prevented talar shift but not talar tilt. Conclusion. If the posterior deep deltoid ligament is intact SER fractures may be managed without surgery in a plantigrade cast. Without immobilisation the talus may tilt, risking deltoid incompetence

Background. Disability and slow return to sport and work after tendon rupture are major challenges. Platelet Rich Plasma (PRP) is an autologous supraphysiological concentration of platelets from whole blood that has demonstrated positive cellular and physiological effects on healing in laboratory conditions but evidence from adequately powered robust clinical trials is lacking. We aimed to determine the clinical efficacy of PRP for treatment of acute Achilles tendon rupture. Methods. In a placebo-controlled, participant- and assessor-blinded, trial at 19 NHS hospitals we randomly assigned 230 adults starting acute Achilles rupture non-surgical management to PRP injection or dry-needle insertion (placebo) to the rupture gap under local anaesthetic. Patients with confounding or contraindicated concurrent medical conditions were excluded. The primary outcome was muscle-tendon function, assessed by the limb symmetry index (LSI, uninjured limb/injured limb × 100, higher scores better) of the work (Joules) performed during the heel-rise endurance test at 24 weeks. Secondary outcomes were: Achilles Tendon Rupture Score (ATRS, 0–100, higher scores better), quality of life (SF-12), pain, and goal attainment. Trial registration: ISRCTN54992179. Results. Participants were aged mean 46 years and 57 (25%) were female. 103/114 (90%) of the PRP group and all (n=116) in the placebo group received allocated treatment. At 24 weeks, mean LSI was 34.4 for the PRP group and 38.8 for placebo (adjusted mean difference −4.4 95% CI −11.2 to 2.5, n=201) and ATRS was mean 65.2 PRP vs 65.8 (adjusted mean difference −0.6, 95% CI −4.9 to 3.7, n=224). There were no differences between groups in the other secondary outcomes. Conclusion. We found no evidence of PRP efficacy for improving muscle-tendon function or patient-reported recovery after acute Achilles tendon rupture. Our findings challenge the increasing global use of PRP for acute tendon injury and indicate that robust evaluations are required in other applications

Introduction/Purpose. A randomized clinical trial of first MTP joint hemiarthroplasty with a synthetic cartilage implant demonstrated equivalent pain, function and safety outcomes to first MTP joint arthrodesis at 2 years. Recognizing that many hemiarthroplasty and total toe implants have initially good results that deteriorate over time, the purpose of this study was to prospectively assess the safety and efficacy outcomes for the synthetic cartilage implant population and to determine if the excellent outcomes were maintained at >5 years. Methods. One hundred nineteen patients were evaluated at 5+ years; 23 could not be reached for follow-up, but implant status was available for 7 of these subjects. Patients completed a pain visual analogue scale (VAS) and Foot and Ankle Ability Measure (FAAM) Sports and Activities of Daily Living (ADL) scores, preoperatively and at 2, 6, 12, 26, 52, 104 and 260 weeks postoperatively. Minimal clinically important differences are: ≥30% difference for pain VAS, 9 points for FAAM Sports, and 8 points for FAAM ADL. Great toe active dorsiflexion, weight-bearing radiographs, secondary procedures, and safety parameters were evaluated. Results. Of 119 patients available at mean 5.8 years follow-up (SD ±0.7; range: 4.4–8.0), 9 underwent implant removal and conversion to fusion in years 2–5, leaving 106 patients. The implant survival rate was 92.4% at 5.8 years. Pain and function outcomes at 5.8 years were similar to those at 2 years. VAS Pain, FAAM Sports, ADL Scores were maintained or improved at 5.8 years. No evidence of avascular necrosis, device migration or fragmentation was observed. There were no unanticipated safety events through 5.8 years. Ninety-three (93%) percent would have the procedure again. Conclusion. The synthetic cartilage hemiarthroplasty implant continues to demonstrate safety and efficacy for the treatment of advanced first MTP joint osteoarthritis with evidence of therapeutic effect and acceptable safety profile at 5.8 years

Aims

The aim of this study was to capture 12-month outcomes from a representative multicentre cohort of patients undergoing total ankle arthroplasty (TAA), describe the pattern of patient-reported outcome measures (PROMs) at 12 months, and identify predictors of these outcome measures.

Aims

The rationale for exacting restoration of skeletal anatomy after unstable ankle fracture is to improve outcomes by reducing complications from malunion; however, current definitions of malunion lack confirmatory clinical evidence.

Aims

Although absorbable sutures for the repair of acute Achilles tendon rupture (ATR) have been attracting attention, the rationale for their use remains insufficient. This study prospectively compared the outcomes of absorbable and nonabsorbable sutures for the repair of acute ATR.

Aims

To identify a core outcome set of postoperative radiographic measurements to assess technical skill in ankle fracture open reduction internal fixation (ORIF), and to validate these against Van der Vleuten’s criteria for effective assessment.

In recent years, the plantaris tendon has been implicated in the development of chronic painful mid-portion Achilles tendinopathy. In some cases, a thickened plantaris tendon is closely associated with the Achilles tendon, and surgical excision of the plantaris tendon has been reported to be curative in patients who have not derived benefit following conservative treatment and surgical interventions. The aim of this review is to outline the basic aspects of, and the recent research findings, related to the plantaris tendon, covering anatomical and clinical studies including those dealing with histology, imaging and treatment. Cite this article: Bone Joint J 2016;98-B:1312–19

Aims

Treatment for delayed wound healing resulting from peripheral vascular diseases and diabetic foot ulcers remains a challenge. A novel surgical technique named ‘tibial cortex transverse transport’ (TTT) has been developed for treating peripheral ischaemia, with encouraging clinical effects. However, its underlying mechanisms remain unclear. In the present study, we explored the potential biological mechanisms of TTT surgery using various techniques in a rat TTT animal model.

Aims

The ideal management of acute syndesmotic injuries in elite athletes is controversial. Among several treatment methods used to stabilize the syndesmosis and facilitate healing of the ligaments, the use of suture tape (InternalBrace) has previously been described. The purpose of this study was to analyze the functional outcome, including American Orthopaedic Foot & Ankle Society (AOFAS) scores, knee-to-wall measurements, and the time to return to play in days, of unstable syndesmotic injuries treated with the use of the InternalBrace in elite athletes.

Aims

A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial.

Introduction. A randomized clinical trial of first metatarsophalangeal (MTP) joint hemiarthroplasty with a synthetic cartilage implant demonstrated equivalent pain, function and safety outcomes to first MTP joint arthrodesis at 2 years. The implant cohort continues to be followed under an extension of the original study and we report on prospectively determined 5+ year outcomes for subjects assessed to date. Methods. Patients treated with hemiarthroplasty implant as part of the previously mentioned trial are eligible for enrollment in the extended study (n=135). At the time of this report, 57 patients had reached the 5+ years postoperative time point, of which 5 were lost to follow-up. The remaining 52 patients with mean age of 58.5 (range, 38.0–0.0) underwent physical examination, radiographic evaluation, assessment of implant survivorship and collection of patient completed VAS pain, and Foot and Ankle Ability Measure (FAAM) sports subscale and activities of daily living (ADL) subscale scores. Mean follow-up is 5.8 (range, 4.8–8.4) years. Results. Patient reported pain and function outcome measures showed clinically and statistically meaningful improvements over baseline at 5.8 years. Mean VAS pain scores decreased 57.9 points (86% pain reduction). The mean FAAM Sports and ADL subscale scores increased from baseline 47.9 points (126%) and 32.7 points (55%) respectively. Patients maintained first MTP joint motion with mean active peak MTP dorsiflexion of 25.9° (range, 0–0°) which was a 3° improvement from baseline. Implant survivorship at 5.8 years was 92%; four were converted to fusion because of persistent pain at mean time 42 months post-operation (range, 26–26 months). These results are equivalent to the outcomes reported at 2 years follow-up. 1. Conclusion. The synthetic cartilage hemiarthroplasty implant continues to demonstrate safety and efficacy for the treatment of advanced first MTP joint osteoarthritis with mid-term evidence of a therapeutic effect and an acceptable safety profile at 5.8 years

Background. MRI is the preferred modality for the diagnosis of ankle joint pathology. Musculoskeletal radiologists aim to determine and report both chondral and/or osseous stability/instability of each lesion. The aim of this study was to specifically analyse the reliability of MRI reported findings in predicting the stability of OCL's in symptomatic patients. Methods. A single centre, single surgeon consecutive series of patients who had undergone an ankle arthroscopy procedure preceded by an MRI scan for symptomatic ankle pathology were included in this retrospective clinical study. All MRI scans were reported by a musculoskeletal radiologist. MRI reports and arthroscopic findings were extracted and analysed. Arthroscopy findings were taken as the gold standard. Results. Between April 2012 and July 2016, 48 patients who fulfilled the above criteria were included. There were 27 male and 21 female patients, the average age was 43.4 (SD 14.1). The average time interval between MRI scan and arthroscopy was 9 months (2–49 months), 28 patients (58.3%) had a right sided pathology. There was a significant negative relationship between OCL's reported as stable on MRI to arthroscopic findings, r=−.31, p=0.03. Of the 21 patients who had OCL's reported as stable on the MRI scan, all had unstable lesions on arthroscopic evaluation (100%). One patient had an unstable OCL reported on the MRI scan and it was also found unstable arthroscopically. In 27 patients, where there was no mention of the stability of the reported OCL on the MRI, 22 patients (81.5%) had unstable lesions and 5 patients (18.5%) had stable lesions on intra-operative arthroscopic findings. Conclusion. This study demonstrates that MRI has a poor predictive value for the stability of OCL's of the ankle. Therefore we recommend that in the symptomatic patient an arthroscopy is indicated irrespective of MRI findings. Evidence. retrospective case review, level IV

Platelet rich plasma has been advocated for the treatment of plantar fasciitis but there are few good quality clinical trials to support its use. We report a pilot double blind randomised controlled trial of platelet rich plasma versus normal saline. Methods. Patients with more than 6 months of MRI proven plantar fasciitis who had failed conservative management were invited to participate in this study. Patients were block randomised to either platelet rich plasma injection (intervention) or equivalent volume of normal saline (control). The techniques used for the injection and rehabilitation were standardised for both groups. The patient and independent assessor were blinded. Visual analogue scale for pain (VAS) and painDETECT were recorded pre-op and at 6 months. Results. Twenty-eight patients (19 females, mean age 50 years) were recruited, with 14 randomised to each arm. At 6 month follow-up, 8 patients (28.6%) were lost to follow-up. There was a significant change in VAS score from baseline to follow-up in both intervention (mean change 37.2, p = 0.008) and control (mean change 42.2, p = 0.003) groups. However there was no difference between the arms in terms of the change in VAS score from baseline to follow-up (p = 0.183). There was no correlation between pre-op PainDETECT score and change in VAS. Conclusion. This pilot study has failed to show a significant benefit of platelet rich plasma compared to saline injection, although both treatments have shown a significant improvement in symptoms. This may be due to the needling effect of injections. A larger study is required to demonstrate a meaningful change. Loss to follow in this patient group should be considered