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. Methods. We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment. Results. Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention arm. Conclusion. This study provided initial information about barriers to recruitment to an orthopaedic randomized controlled trial. We shared these findings in an all-site investigators’ meeting and encouraged researchers to find solutions to identified barriers; this led to the successful completion of recruitment. Complex trials may benefit for using of a mixed-methods approach to mitigate against recruitment failure, and to improve patient participation and informed consent. Cite this article: Bone Jt Open 2021;2(8):631–637

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To systematically review qualitative studies of patients with distal tibia or ankle fracture, and explore their experience of injury and recovery.

Aims

The Manchester-Oxford Foot Questionnaire (MOxFQ) is an anatomically specific patient-reported outcome measure (PROM) currently used to assess a wide variety of foot and ankle pathology. It consists of 16 items across three subscales measuring distinct but related traits: walking/standing ability, pain, and social interaction. It is the most used foot and ankle PROM in the UK. Initial MOxFQ validation involved analysis of 100 individuals undergoing hallux valgus surgery. This project aimed to establish whether an individual’s response to the MOxFQ varies with anatomical region of disease (measurement invariance), and to explore structural validity of the factor structure (subscale items) of the MOxFQ.

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This study reports updates the previously published two-year clinical, functional, and radiological results of a group of patients who underwent transfibular total ankle arthroplasty (TAA), with follow-up extended to a minimum of five years.

Aims

A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures.

The foot and ankle outcome score (FAOS) has been evaluated for many conditions of the foot and ankle. We evaluated its construct validity in 136 patients with osteoarthritis of the ankle, its content validity in 37 patients and its responsiveness in 39. Data were collected prospectively from the registry of patients at our institution.

All FAOS subscales were rated relevant by patients. The Pain, Activities of Daily Living, and Quality of Life subscales showed good correlation with the Physical Component score of the Short-Form-12v2. All subscales except Symptoms were responsive to change after surgery.

We concluded that the FAOS is a weak instrument for evaluating osteoarthritis of the ankle. However, some of the FAOS subscales have relative strengths that allow for its limited use while we continue to seek other satisfactory outcome instruments.

Cite this article: Bone Joint J 2015; 97-B:662–7.

Flexor digitorum longus transfer and medial displacement calcaneal osteotomy is a well-recognised form of treatment for stage II posterior tibial tendon dysfunction. Although excellent short- and medium-term results have been reported, the long-term outcome is unknown. We reviewed the clinical outcome of 31 patients with a symptomatic flexible flat-foot deformity who underwent this procedure between 1994 and 1996. There were 21 women and ten men with a mean age of 54.3 years (42 to 70). The mean follow-up was 15.2 years (11.4 to 16.5). All scores improved significantly (p < 0.001). The mean American Orthopedic Foot and Ankle Society (AOFAS) score improved from 48.4 pre-operatively to 90.3 (54 to 100) at the final follow-up. The mean pain component improved from 12.3 to 35.2 (20 to 40). The mean function score improved from 35.2 to 45.6 (30 to 50). The mean visual analogue score for pain improved from 7.3 to 1.3 (0 to 6). The mean Short Form-36 physical component score was 40.6 (sd 8.9), and this showed a significant correlation with the mean AOFAS score (r = 0.68, p = 0.005). A total of 27 patients (87%) were pain free and functioning well at the final follow-up. We believe that flexor digitorum longus transfer and calcaneal osteotomy provides long-term pain relief and satisfactory function in the treatment of stage II posterior tibial tendon dysfunction.

Cite this article: Bone Joint J 2015;97-B:346–52.

The responsiveness of the Manchester–Oxford Foot Questionnaire (MOXFQ) was compared with foot/ankle-specific and generic outcome measures used to assess all surgery of the foot and ankle. We recruited 671 consecutive adult patients awaiting foot or ankle surgery, of whom 427 (63.6%) were female, with a mean age of 52.8 years (18 to 89). They independently completed the MOXFQ, Short-Form 36 (SF-36) and EuroQol (EQ-5D) questionnaires pre-operatively and at a mean of nine months (3.8 to 14.4) post-operatively. Foot/ankle surgeons assessed American Orthopaedic Foot and Ankle Society (AOFAS) scores corresponding to four foot/ankle regions. A transition item measured perceived changes in foot/ankle problems post-surgery. Of 628 eligible patients proceeding to surgery, 491 (78%) completed questionnaires and 262 (42%) received clinical assessments both pre- and post-operatively. The regions receiving surgery were: multiple/whole foot in eight (1.3%), ankle/hindfoot in 292 (46.5%), mid-foot in 21 (3.3%), hallux in 196 (31.2%), and lesser toes in 111 (17.7%). Foot/ankle-specific MOXFQ, AOFAS and EQ-5D domains produced larger effect sizes (> 0.8) than any SF-36 domains, suggesting superior responsiveness. In analyses that anchored change in scores and effect sizes to patients’ responses to a transition item about their foot/ankle problems, the MOXFQ performed well. The SF-36 and EQ-5D performed poorly. Similar analyses, conducted within foot-region based sub-groups of patients, found that the responsiveness of the MOXFQ was good compared with the AOFAS.

This evidence supports the MOXFQ’s suitability for assessing all foot and ankle surgery.

We have evaluated the clinical effectiveness of a metal resurfacing inlay implant for osteochondral defects of the medial talar dome after failed previous surgical treatment. We prospectively studied 20 consecutive patients with a mean age of 38 years (20 to 60), for a mean of three years (2 to 5) post-surgery. There was statistically significant reduction of pain in each of four situations (i.e., rest, walking, stair climbing and running; p ≤ 0.01). The median American Orthopaedic Foot and Ankle Society ankle-hindfoot score improved from 62 (interquartile range (IQR) 46 to 72) pre-operatively to 87 (IQR 75 to 95) at final follow-up (p < 0.001). The Foot and Ankle Outcome Score improved on all subscales (p ≤ 0.03). The mean Short-Form 36 physical component scale improved from 36 (23 to 50) pre-operatively to 45 (29 to 55) at final follow-up (p = 0.001); the mental component scale did not change significantly. On radiographs, progressive degenerative changes of the opposing tibial plafond were observed in two patients. One patient required additional surgery for the osteochondral defect. This study shows that a metal implant is a promising treatment for osteochondral defects of the medial talar dome after failed previous surgery.

Cite this article: Bone Joint J 2013;95-B:1650–5.

We present the outcomes in 38 consecutive patients who had total ankle replacement using the Ankle Evolution System with a minimum follow-up of four years. Pain and function were assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) score and regular standardised anteroposterior and lateral weight-bearing radiographs were obtained. Patient satisfaction and complications were recorded and the survival of the implants was demonstrated by the Kaplan-Meier method.

The mean follow-up was for 57.8 months (48 to 80). The cumulative survival rate at six years was 94.7% (95% confidence interval 80.3 to 98.7). The mean total AOFAS score was 88.1 (53 to 100). The mean score for pain was 35.8 (20 to 40). Ten patients presented with edge-loading of whom nine had corrective surgery. Two ankles were revised, one to an arthrodesis and the other to replace the tibial component. Nine patients showed radiological evidence of osteolysis. They had minimal non-progressive symptoms and further surgery was not undertaken. Nevertheless, the concerns about osteolysis led to the implant being withdrawn by the manufacturer.

The medium-term results of the ankle evolution system ankle replacement are satisfactory with high patient satisfaction, but the rate of osteolysis is of some concern. The long-term benefit of this procedure has yet to be determined.

A total of 80 patients with an acute rupture of tendo Achillis were randomised to operative repair using an open technique (39 patients) or non-operative treatment in a cast (41 patients). Patients were followed up for one year. Outcome measures included clinical complications, range of movement of the ankle, the Short Musculoskeletal Function Assessment (SMFA), and muscle function dynamometry evaluating dorsiflexion and plantar flexion of the ankle. The primary outcome measure was muscle dynamometry.

Re-rupture occurred in two of 37 patients (5%) in the operative group and four of 39 (10%) in the non-operative group, which was not statistically significant (p = 0.68). There was a slightly greater range of plantar flexion and dorsiflexion of the ankle in the operative group at three months which was not statistically significant, but at four and six months the range of dorsiflexion was better in the non-operative group, although this did not reach statistically significance either. After 12 weeks the peak torque difference of plantar flexion compared with the normal side was less in the operative than the non-operative group (47% vs 61%, respectively, p < 0.005). The difference declined to 26% and 30% at 26 weeks and 20% and 25% at 52 weeks, respectively. The difference in dorsiflexion peak torque from the normal side was less than 10% by 26 weeks in both groups, with no significant differences. The mean SMFA scores were significantly better in the operative group than the non-operative group at three months (15 vs 20, respectively, p < 0.03). No significant differences were observed after this, and at one year the scores were similar in both groups.

We were unable to show a convincing functional benefit from surgery for patients with an acute rupture of the tendo Achillis compared with conservative treatment in plaster.

There are few data available regarding the association between hallux valgus and pain or functional limitation. We determined the prevalence of hallux valgus in a rural Korean population aged between 40 and 69 years, and its association with pain and function. A total of 563 subjects was examined using the foot health status questionnaire, the Short Form-36 questionnaire and weight-bearing anteroposterior radiographs.

Hallux valgus was present in 364 subjects (64.7%). It did not significantly correlate with age and was more common in women. Of the 364 subjects, 48 (13.2%) had moderate or greater deformity, defined as a hallux valgus angle > 25°. This was significantly associated with pain, worse function and worse foot health. The putative risk factors associated with painful hallux valgus were female gender, low educational attainment and the presence of pain in the knee.

We describe the medium-term results of a prospective study of 200 total ankle replacements at a single-centre using the Scandinavian Total Ankle Replacement. A total of 24 ankles (12%) have been revised, 20 by fusion and four by further replacement and 27 patients (33 ankles) have died. All the surviving patients were seen at a minimum of five years after operation. The five-year survival was 93.3% (95% confidence interval (CI) 89.8 to 96.8) and the ten-year survival 80.3% (95% CI 71.0 to 89.6).

Anterior subluxation of the talus, often seen on the lateral radiograph in osteoarthritic ankles, was corrected and, in most instances, the anatomical alignment was restored by total ankle replacement. The orientation of the tibial component, as seen on the lateral radiograph, also affects the position of the talus and if not correct can hold the talus in an abnormal anterior position. Subtalar arthritis may continue to progress after total ankle replacement. Our results are similar to those published previously.