This study sought to determine the medium-term patient-reported and radiographic outcomes in patients undergoing surgery for hallux valgus. A total of 118 patients (162 feet) underwent surgery for hallux valgus between January 2008 and June 2009. The Manchester-Oxford Foot Questionnaire (MOXFQ), a validated tool for the assessment of outcome after surgery for hallux valgus, was used and patient satisfaction was sought. The medical records and radiographs were reviewed retrospectively. At a mean of 5.2 years (4.7 to 6.0) post-operatively, the median combined MOXFQ score was 7.8 (IQR:0 to 32.8). The median domain scores for pain, walking/standing, and social interaction were 10 (IQR: 0 to 45), 0 (IQR: 0 to 32.1) and 6.3 (IQR: 0 to 25) respectively. A total of 119 procedures (73.9%, in 90 patients) were reported as satisfactory but only 53 feet (32.7%, in 43 patients) were completely asymptomatic. The mean (SD) correction of hallux valgus, intermetatarsal, and distal metatarsal articular angles was 18.5° (8.8°), 5.7° (3.3°), and 16.6° (8.8°), respectively. Multivariable regression analysis identified that an American Association of Anesthesiologists grade of > 1 (Incident Rate Ratio (IRR) = 1.67, p-value = 0.011) and recurrent deformity (IRR = 1.77, p-value = 0.003) were associated with significantly worse MOXFQ scores. No correlation was found between the severity of deformity, the type, or degree of surgical correction and the outcome. When using a validated outcome score for the assessment of outcome after surgery for hallux valgus, the long-term results are worse than expected when compared with the short- and mid-term outcomes, with 25.9% of patients dissatisfied at a mean follow-up of 5.2 years. Cite this article: Bone Joint J 2015;97-B:208–14

Aims. Venous thromboembolism (VTE) is a potential complication of foot and ankle surgery. There is a lack of agreement on contributing risk factors and chemical prophylaxis requirements. The primary outcome of this study was to analyze the 90-day incidence of symptomatic VTE and VTE-related mortality in patients undergoing foot and ankle surgery and Achilles tendon (TA) rupture. Secondary aims were to assess the variation in the provision of chemical prophylaxis and risk factors for VTE. Methods. This was a multicentre, prospective national collaborative audit with data collection over nine months for all patients undergoing foot and ankle surgery in an operating theatre or TA rupture treatment, within participating UK hospitals. The association between VTE and thromboprophylaxis was assessed with a univariable logistic regression model. A multivariable logistic regression model was used to identify key predictors for the risk of VTE. Results. A total of 13,569 patients were included from 68 sites. Overall, 11,363 patients were available for analysis: 44.79% were elective (n = 5,090), 42.16% were trauma excluding TA ruptures (n = 4,791), 3.50% were acute diabetic procedures (n = 398), 2.44% were TA ruptures undergoing surgery (n = 277), and 7.10% were TA ruptures treated nonoperatively (n = 807). In total, 11 chemical anticoagulants were recorded, with the most common agent being low-molecular-weight heparin (n = 6,303; 56.79%). A total of 32.71% received no chemical prophylaxis. There were 99 cases of VTE (incidence 0.87% (95% CI 0.71 to 1.06)). VTE-related mortality was 0.03% (95% CI 0.005 to 0.080). Univariable analysis showed that increased age and American Society of Anesthesiologists (ASA) grade had higher odds of VTE, as did having previous cancer, stroke, or history of VTE. On multivariable analysis, the strongest predictors for VTE were the type of foot and ankle procedure and ASA grade. Conclusion. The 90-day incidence of symptomatic VTE and mortality related to VTE is low in foot and ankle surgery and TA management. There was notable variability in the chemical prophylaxis used. The significant risk factors associated with 90-day symptomatic VTE were TA rupture and high ASA grade. Cite this article: Bone Joint J 2024;106-B(11):1249–1256

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. Methods. An e-Delphi exercise was undertaken at a major trauma centre (n = 39) to identify relevant parameters. Feasibility was tested by two authors. Reliability and validity was tested using postoperative radiographs of ankle fracture operations performed by trainees enrolled in an educational trial (IRCTN 20431944). To determine construct validity, trainees were divided into novice (performed < ten cases at baseline) and intermediate groups (performed ≥ ten cases at baseline). To assess concurrent validity, the procedure-based assessment (PBA) was considered the gold standard. The inter-rater and intrarater reliability was tested using a randomly selected subset of 25 cases. Results. Overall, 235 ankle ORIFs were performed by 24 postgraduate year three to five trainees during ten months at nine NHS hospitals in England, UK. Overall, 42 PBAs were completed. The e-Delphi panel identified five ‘final product analysis’ parameters and defined acceptability thresholds: medial clear space (MCS); medial malleolar displacement (MMD); lateral malleolar displacement (LMD); tibiofibular clear space (TFCS) (all in mm); and talocrural angle (TCA) in degrees. Face validity, content validity, and feasibility were excellent. PBA global rating scale scores in this population showed excellent construct validity as continuous (p < 0.001) and categorical (p = 0.001) variables. Concurrent validity of all metrics was poor against PBA score. Intrarater reliability was substantial for all parameters (intraclass correlation coefficient (ICC) > 0.8), and inter-rater reliability was substantial for LMD, MMD, TCA, and moderate (ICC 0.61 to 0.80) for MCS and TFCS. Assessment was time efficient compared to PBA. Conclusion. Assessment of technical skill in ankle fracture surgery using the first postoperative radiograph satisfies the tested Van der Vleuten’s utility criteria for effective assessment. 'Final product analysis' assessment may be useful to assess skill transfer in the simulation-based research setting. Cite this article: Bone Jt Open 2022;3(6):502–509

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 analysed the clinical and radiological outcomes of a new surgical technique for the treatment of heterozygote post-axial metatarsal-type foot synpolydactyly with HOX-D13 genetic mutations with a mean follow-up of 30.9 months (24 to 42). A total of 57 feet in 36 patients (mean age 6.8 years (2 to 16)) were treated with this new technique, which transfers the distal part of the duplicated fourth metatarsal to the proximal part of the fifth metatarsal. Clinical and radiological assessments were undertaken pre- and post-operatively and any complications were recorded. Final outcomes were evaluated according to the methods described by Phelps and Grogan. Forefoot width was reduced and the lengths of the all reconstructed toes were maintained after surgery. Union was achieved for all the metatarsal osteotomies without any angular deformities. Outcomes at the final assessment were excellent in 51 feet (89%) and good in six (11%). This newly described surgical technique provides for painless, comfortable shoe-wearing after a single, easy-to-perform operation with good clinical, radiological and functional outcomes. Cite this article: Bone Joint J 2013;95-B:929–34

Objectives. The Manchester–Oxford Foot Questionnaire (MOXFQ) is a validated 16-item, patient-reported outcome measure for evaluating outcomes of foot or ankle surgery. The original development of the instrument identified three domains. This present study examined whether the three domains could legitimately be summed to provide a single summary index score. . Methods. The MOXFQ and Short-Form (SF)-36 were administered to 671 patients before surgery of the foot or ankle. Data from the three domains of the MOXFQ (pain, walking/standing and social interaction) were subjected to higher order factor analysis. Reliability and validity of the summary index score was assessed. Results. The mean age of the participants was 52.8 years (. sd. 15.68; 18 to 89). Higher order principle components factor analysis produced one factor, accounting for 74.7% of the variance. The newly derived single index score was found to be internally reliable (α = 0.93) and valid, achieving at least moderate correlations (r ≥ 0.5, p < 0.001) with related (pain/function) domains of the SF-36. Conclusions. Analyses indicated that data from the MOXFQ can be presented in summary form. The MOXFQ summary index score (MOXFQ-Index) provides an overall indication of the outcomes of foot and ankle surgery. Furthermore, the single index reduces the number of statistical comparisons, and hence the role of chance, when exploring MOXFQ data

Aims. The purpose of this study was to analyse the biomechanics of walking, through the ground reaction forces (GRF) measured, after first metatarsal osteotomy or metatarsophalangeal joint (MTP) arthrodesis. Patients and Methods. A total of 19 patients underwent a Scarf osteotomy (50.3 years, standard deviation (. sd. ) 12.3) and 18 underwent an arthrodesis (56.2 years,. sd. 6.5). Clinical and radiographical data as well as the American Orthopaedic Foot and Ankle Society (AOFAS) scores were determined. GRF were measured using an instrumented treadmill. A two-way model of analysis of variance (ANOVA) was used to determine the effects of surgery on biomechanical parameters of walking, particularly propulsion. Results. Epidemiological, radiographical and clinical data were comparable in the two groups and better restoration of propulsive function was found after osteotomy as shown by ANOVA (two way: surgery × foot) with a surgery effect on vertical forces (p < 0.01) and a foot effect on anteroposterior impulse (p = 0.01). Conclusion. Patients who underwent Scarf osteotomy had a gait pattern similar to that of their non-operated foot, whereas those who underwent arthrodesis of the first (metatarsophalangeal) MTP joint did not totally recover the propulsive forces of the forefoot. Take home message: The main findings of this study were that after surgical correction for hallux valgus, patients who underwent scarf osteotomy had a gait pattern similar to that of their non-operated foot in terms of forefoot propulsive forces (Fz3, Iy2), whereas those who underwent arthrodesis of the first MTP joint had not. Cite this article: Bone Joint J 2016;98-B:641–6

Aims. Various radiological parameters are used to evaluate a flatfoot deformity and their measurements may differ. The aims of this study were to answer the following questions: 1) Which of the 11 parameters have the best inter- and intraobserver reliability in a standardized radiological setting? 2) Are pre- and postoperative assessments equally reliable? 3) What are the identifiable sources of variation?. Patients and Methods. Measurements of the 11 parameters were recorded on anteroposterior and lateral weight-bearing radiographs of 38 feet before and after surgery for flatfoot, by three observers with different experience in foot surgery (A, ten years; B, three years; C, third-year orthopaedic resident). The inter- and intraobserver reliability was calculated. Results. Preoperative interobserver reliability was high for four, moderate for five, and low for two parameters. Postoperative interobserver reliability was high for four, moderate for five, and low for two parameters. Intraobserver reliability was excellent for all parameters preoperatively as recorded by observer A (PB) and B (MP), and for eight parameters as recorded by observer C (SR). Intraobserver reliability was excellent for ten parameters postoperatively as recorded by observer A and B, and for eight parameters as recorded by observer C. Conclusion. The following parameters can be recommended. For preoperative and postoperative evaluation of flatfoot: anteroposterior, talonavicular coverage angle; lateral, talometatarsal I angle, calcaneal pitch angle, and cuneiform-medial height (high interobserver reliability); and anteroposterior, talometatarsal II angle; lateral, talocalcaneal angle,tibiocalcaneal angle (moderate interobserver reliability). For more experienced observers, we also recommend the anteroposterior talometatarsal I angle (moderate reliability). The inter- and intraobserver reliability for most parameters were similar pre- and postoperatively. The experience of the observer and the definition and ability to measure the parameters themselves were sources of variation. Cite this article: Bone Joint J 2018;100-B:596–602

The rate of surgical site infection after elective foot and ankle surgery is higher than that after other elective orthopaedic procedures.

Since December 2005, we have prospectively collected data on the rate of post-operative infection for 1737 patients who have undergone elective foot and ankle surgery. In March 2008, additional infection control policies, focused on surgical and environmental risk factors, were introduced in our department.

We saw a 50% reduction in the rate of surgical site infection after the introduction of these measures. We are, however, aware that the observed decrease may not be entirely attributable to these measures alone given the number of factors that predispose to post-operative wound infection.

Cite this article: Bone Joint J 2015;97-B:516–19.

Aims. Lifestyle risk factors are thought to increase the risk of infection after acute orthopaedic surgery but the evidence is scarce. We aimed to investigate whether smoking, obesity and alcohol overuse are risk factors for the development of infections after surgery for a fracture of the ankle. Patients and Methods. We retrospectively reviewed all patients who underwent internal fixation of a fracture of the ankle between 2008 and 2013. The primary outcome was the rate of deep infection and the secondary outcome was any surgical site infection (SSI). Associations with the risk factors and possible confounding variables were analysed univariably and multivariably with backwards elimination. Results. A total of 1043 patients were included; 64 (6.1%) had a deep infection and 146 (14.0%) had SSI. Obesity was strongly associated with both outcomes (odds ratio (OR) 2.21, p = 0.017 and OR 1.68, p = 0.032) in all analyses. Alcohol overuse was similarly associated, though significant only in unadjusted analyses. Surprisingly, smoking did not yield statistically significant associations with infections. Conclusion. These findings suggest that obesity and possibly alcohol overuse are independent risk factors for the development of infection following surgery for a fracture of the ankle. This large study brings new evidence concerning these common risk factors; although prospective studies are needed to confirm causality. Cite this article: Bone Joint J 2017;99-B:225–30

While many forefoot procedures may be performed as a day case, there are no specific guidelines as to which procedures are suitable. This study assessed the early post-operative pain after forefoot surgery performed a day case, compared with conventional inpatient management. A total of 317 consecutive operations performed by a single surgeon were included in the study. Those eligible according to the criteria of the French Society of Anaesthesia (SFAR) were managed as day cases (127; 40%), while the remainder were managed as inpatients. . The groups were comparable in terms of gender, body mass index and smoking status, although the mean age of the inpatients was higher (p < 0.001) and they had higher mean American Society of Anaesthesiologists scores (p = 0.002). The most severe daily pain was on the first post-operative day, but the levels of pain were similar in the two groups; (4.2/10, . sd. 2.5 for day cases, 4.4/10, . sd. 2.4 for inpatients; p = 0.53). Overall, 28 (9%) of patients who had their surgery as a day case and 34 (11%) of inpatients reported extreme pain (≥ 8/10). There were more day case patients rather than inpatients that declared their pain disappeared seven days after the surgery (p = 0.02). One day-case patient with excessive bleeding was admitted post-operatively. Apart from the most complicated cases, forefoot surgery can safely be performed as a day case without an increased risk of pain, or complications compared with management as an inpatient. Cite this article: Bone Joint J 2015;97-B:1645–50

Proximal osteotomies for forefoot deformity in patients with rheumatoid arthritis have hitherto not been described. We evaluated combination joint-preserving surgery involving three different proximal osteotomies for such deformities. A total of 30 patients (39 feet) with a mean age of 55.6 years (45 to 67) underwent combined first tarsometatarsal fusion and distal realignment, shortening oblique osteotomies of the bases of the second to fourth metatarsals and a fifth-ray osteotomy. The mean follow-up was 36 months (24 to 68). The mean foot function index scores for pain, disability and activity subscales were 18, 23, and 16 respectively. The mean Japanese Society for Surgery of the Foot score improved significantly from 52.2 (41 to 68) to 89.6 (78 to 97). Post-operatively, 14 patients had forefoot stiffness, but had no disability. Most patients reported highly satisfactory walking ability. Residual deformity and callosities were absent. The mean hallux valgus and intermetatarsal angles decreased from 47.0° (20° to 67°) to 9.0° (2° to 23°) and from 14.1° (9° to 20°) to 4.6° (1° to 10°), respectively. Four patients had further surgery including removal of hardware in three and a fifth-ray osteotomy in one. With good peri-operative medical management of rheumatoid arthritis, surgical repositioning of the metatarsophalangeal joint by metatarsal shortening and consequent relaxing of surrounding soft tissues can be successful. In early to intermediate stages of the disease, it can be performed in preference to joint-sacrificing procedures

We randomised prospectively 60 consecutive patients who were undergoing internal fixation of similar fractures of the ankle into two groups, one of which was treated by immobilisation in a below-knee cast and the other by a functional brace with early movement. All were instructed to avoid weight-bearing on the affected side. They were seen at 6, 12, 26 and 52 weeks. The functional rating scale of Mazur et al was used to evaluate the patients at each follow-up and we recorded the time of return to work. After one year the patients completed the SF-36 questionnaire. By then 55 patients remained in the study, 28 (mean age 45.5 years) in group 1 and 27 (mean age 39.5 years) in group 2. Those in group 2 had higher functional scores at each follow-up but only at six weeks was this difference significant (p = 0.02). They also had higher mean SF-36 scores, but this difference was significant only for two of the eight aspects investigated. For patients gainfully employed, not on workers’ compensation, the mean time from surgery to return to work was 53.3 days for group 2 and 106.5 days for group 1; this difference was significant (p = 0.01). No patient developed a problem with the wound or had loss of fixation. Our findings support the use of a functional brace and early movement after surgery for fractures of the ankle

We reviewed the outcome of distal chevron metatarsal osteotomy without tendon transfer in 19 consecutive patients (19 feet) with a hallux varus deformity following surgery for hallux valgus. All patients underwent distal chevron metatarsal osteotomy with medial displacement and a medial closing wedge osteotomy along with a medial capsular release. The mean hallux valgus angle improved from −11.6° pre-operatively to 4.7° postoperatively, the mean first-second intermetatarsal angle improved from −0.3° to 3.3° and the distal metatarsal articular angle from 9.5° to 2.3° and the first metatarsophalangeal joints became congruent post-operatively in all 19 feet. The mean relative length ratio of the metatarsus decreased from 1.01 to 0.99 and the mean American Orthopaedic Foot and Ankle Society score improved from 77 to 95 points. In two patients the hallux varus recurred. One was symptom-free but the other remained symptomatic after a repeat distal chevron osteotomy. There were no other complications. We consider that distal chevron metatarsal osteotomy with a medial wedge osteotomy and medial capsular release is a useful procedure for the correction of hallux varus after surgery for hallux valgus

The consequences of breakdown of the wound after surgery to tendo Achillis are considerable. Complex surgery is often required to reconstruct the tendon and to provide soft-tissue cover. We describe a new incision which approaches the tendon by using a distally-based fasciocutaneous flap. This reduces the risk of breakdown of the wound since it avoids making an incision directly over the tendon, provides good exposure, and maintains the vascularity of the skin overlying the tendon

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 carried out a prospective study over a period of 12 months to measure the exposure to radiation of the hands of a dedicated foot and ankle surgeon. A thermoluminescent dosimeter ring (TLD) was used to measure the cumulative dose of radiation. Fluoroscopy was used in operations on the foot and ankle. The total screening time was 3028 s, with a mean time per procedure of 37.4 s (0.6 to 197). This correlated positively with the number of procedures performed (r = 0.92, p < 0.001), and with the dose of radiation in both the left (r = 0.85, p = 0.0005) and right TLDs (r = 0.59, p = 0.419). There was no significant difference in the dose of radiation between the two hands (t-test, p = 0.62). The total dose to the right TLD over the 12 months was 2.4 millisieverts.

This is a simple and convenient method for evaluating the exposure of a single surgeon to radiation. The radiation detected was well below the annual dose limit set by the International Commission on Radiological Protection.

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. Methods. Patients listed for a primary TAA at 19 NHS hospitals between February 2016 and October 2017 were eligible. PROMs data were collected preoperatively and at six and 12 months including: Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ (foot and ankle)) and the EuroQol five-dimension five-level questionnaire (EQ-5D-5L). Radiological pre- and postoperative data included Kellgren-Lawrence score and implant position measurement. This was supplemented by data from the National Joint Registry through record linkage to determine: American Society of Anesthesiologists (ASA) grade at index procedure; indication for surgery, index ankle previous fracture; tibial hind foot alignment; additional surgery at the time of TAA; and implant type. Multivariate regression models assessed outcomes, and the relationship between MOXFQ and EQ-5D-5L outcomes, with patient characteristics. Results. Data from 238 patients were analyzed. There were significant improvements in MOXFQ and EQ-5D-5L among people who underwent TAA at six- and 12-month assessments compared with preoperative scores (p < 0.001). Most improvement occurred between preoperative and six months, with little further improvement at 12 months. A greater improvement in MOXFQ outcome postoperatively was associated with older age and more advanced radiological signs of ankle osteoarthritis at baseline. Conclusion. TAA significantly benefits patients with end-stage ankle disease. The lack of substantial further overall change between six and 12 months suggests that capturing PROMs at six months is sufficient to assess the success of the procedure. Older patients and those with advanced radiological disease had the greater gains. These outcome predictors can be used to counsel younger patients and those with earlier ankle disease on the expectations of TAA. Cite this article: Bone Joint J 2023;105-B(8):895–904

Aims. Diabetic foot care is a significant burden on the NHS in England. We have conducted a nationwide survey to determine the current participation of orthopaedic surgeons in diabetic foot care in England. Methods. A questionnaire was sent to all 136 NHS trusts audited in the 2018 National Diabetic Foot Audit (NDFA). The questionnaire asked about the structure of diabetic foot care services. Results. Overall, 123 trusts responded, of which 117 admitted patients with diabetic foot disease and 113 had an orthopaedic foot and ankle surgeon. A total of 90 trusts (77%) stated that the admission involved medicine, with 53 (45%) of these admissions being exclusively under medicine, and 37 (32%) as joint admissions. Of the joint admissions, 16 (14%) were combined with vascular and 12(10%) with orthopaedic surgery. Admission is solely under vascular surgery in 12 trusts (10%) and orthopaedic surgery in 7 (6%). Diabetic foot abscesses were drained by orthopaedic surgeons in 61 trusts (52%) and vascular surgeons in 47 (40%). Conclusion. Orthopaedic surgeons make a significant contribution to both acute and elective diabetic foot care currently in the UK. This contribution is likely to increase with the movement of vascular surgery to a hub and spoke model, and measures should be put in place to increase the team based approach to the diabetic foot, for example with the introduction of a best practice tariff. Cite this article: Bone Jt Open 2022;3(8):618–622

Aims. Arthroscopic microfracture is a conventional form of treatment for patients with osteochondritis of the talus, involving an area of < 1.5 cm. 2. However, some patients have persistent pain and limitation of movement in the early postoperative period. No studies have investigated the combined treatment of microfracture and shortwave treatment in these patients. The aim of this prospective single-centre, randomized, double-blind, placebo-controlled trial was to compare the outcome in patients treated with arthroscopic microfracture combined with radial extracorporeal shockwave therapy (rESWT) and arthroscopic microfracture alone, in patients with ostechondritis of the talus. Methods. Patients were randomly enrolled into two groups. At three weeks postoperatively, the rESWT group was given shockwave treatment, once every other day, for five treatments. In the control group the head of the device which delivered the treatment had no energy output. The two groups were evaluated before surgery and at six weeks and three, six and 12 months postoperatively. The primary outcome measure was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale. Secondary outcome measures included a visual analogue scale (VAS) score for pain and the area of bone marrow oedema of the talus as identified on sagittal fat suppression sequence MRI scans. Results. A total of 40 patients were enrolled and randomly divided into the two groups, with 20 in each. There was no statistically significant difference in the baseline characteristics of the groups. No complications, such as wound infection or neurovascular injury, were found during follow-up of 12 months. The mean AOFAS scores in the rESWT group were significantly higher than those in the control group at three, six, and 12 months postoperatively (p < 0.05). The mean VAS pain scores in the rESWT group were also significantly lower than those in the control group at these times (p < 0.05). The mean area of bone marrow oedema in the rESWT group was significantly smaller at six and 12 months than in the control group at these times (p < 0.05). Conclusion. Local shockwave therapy was safe and effective in patients with osteochondiritis of the talus who were treated with a combination of arthroscopic surgery and rESWT. Preliminary results showed that, compared with arthroscopic microfracture alone, those treated with arthroscopic microfracture combined with rESWT had better relief of pain at three months postoperatively and improved weightbearing and motor function of the ankle. Cite this article: Bone Joint J 2023;105-B(10):1108–1114

Aims. The number of revision total ankle arthroplasties (TAAs) which are undertaken is increasing. Few studies have reported the survival after this procedure. The primary aim of this study was to analyze the survival of revision ankle arthroplasties using large datasets. Secondary aims were to summarize the demographics of the patients, the indications for revision TAA, further operations, and predictors of survival. Methods. The study combined data from the National Joint Registry and NHS Digital to report the survival of revision TAA. We have previously reported the failure rates and risk factors for failure after TAA, and the outcome of fusion after a failed TAA, using the same methodology. Survival was assessed using life tables and Kaplan Meier graphs. Cox proportional hazards regression models were fitted to compare failure rates. Results. A total of 228 patients underwent revision TAA. The mean follow-up was 2.6 years (SD 2.0). The mean time between the initial procedure and revision was 2.3 years (SD 1.8). The most commonly used implant was the Inbone which was used in 81 patients. A total of 29 (12.7%) failed; nine (3.9%) patients underwent a further revision, 19 (8.3%) underwent a fusion, and one (0.4%) had an amputation. The rate of survival was 95.4% (95% confidence interval (CI) 91.6 to 97.5) at one year, 87.7% (95% CI 81.9 to 91.7; n = 124) at three years and 77.5% (95% CI 66.9 to 85.0; n = 57) at five years. Revision-specific implants had a better survival than when primary implants were used at revision. A total of 50 patients (21.9%) had further surgery; 19 (8.3%) underwent reoperation in the first 12 months. Cox regression models were prepared. In crude analysis the only significant risk factors for failure were the use of cement (hazard ratio (HR) 3.02 (95% CI 1.13 to 8.09)) and the time since the primary procedure (HR 0.67 (95% CI 0.47 to 0.97)). No risk factors for failure were identified in multivariable Cox regression modelling. Conclusion. Revision TAAs have good medium term survival and low rates of further surgery. New modular revision implants appear to have improved the survival compared with the use of traditional primary implants at revision. Cite this article: Bone Joint J 2023;105-B(11):1184–1188

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. Methods. A total of 40 patients were randomly assigned to either braided absorbable polyglactin suture or braided nonabsorbable polyethylene terephthalate suture groups. ATR was then repaired using the Krackow suture method. At three and six months after surgery, the isokinetic muscle strength of ankle plantar flexion was measured using a computer-based Cybex dynamometer. At six and 12 months after surgery, patient-reported outcomes were measured using the Achilles tendon Total Rupture Score (ATRS), visual analogue scale for pain (VAS pain), and EuroQoL five-dimension health questionnaire (EQ-5D). Results. Overall, 37 patients completed 12 months of follow-up. No difference was observed between the two groups in terms of isokinetic plantar flexion strength, ATRS, VAS pain, or EQ-5D. No re-rupture was observed in either group. Conclusion. The use of absorbable sutures for the repair of acute ATR was not inferior to that of nonabsorbable sutures. This finding suggests that absorbable sutures can be considered for the repair of acute ATRs. Cite this article: Bone Joint J 2022;104-B(8):938–945

Aims. Achilles tendon re-rupture (ATRR) poses a significant risk of postoperative complication, even after a successful initial surgical repair. This study aimed to identify risk factors associated with Achilles tendon re-rupture following operative fixation. Methods. This retrospective cohort study analyzed a total of 43,287 patients from national health claims data spanning 2008 to 2018, focusing on patients who underwent surgical treatment for primary Achilles tendon rupture. Short-term ATRR was defined as cases that required revision surgery occurring between six weeks and one year after the initial surgical repair, while omitting cases with simultaneous infection or skin necrosis. Variables such as age, sex, the presence of Achilles tendinopathy, and comorbidities were systematically collected for the analysis. We employed multivariate stepwise logistic regression to identify potential risk factors associated with short-term ATRR. Results. From 2009 to 2018, the short-term re-rupture rate for Achilles tendon surgeries was 2.14%. Risk factors included male sex, younger age, and the presence of Achilles tendinopathy. Conclusion. This large-scale, big-data study reaffirmed known risk factors for short-term Achilles tendon re-rupture, specifically identifying male sex and younger age. Moreover, this study discovered that a prior history of Achilles tendinopathy emerges as an independent risk factor for re-rupture, even following initial operative fixation. Cite this article: Bone Joint Res 2024;13(7):315–320

Aims. This study aimed to compare the outcomes of two different postoperative management approaches following surgical fixation of ankle fractures: traditional cast immobilization versus the Early Motion and Directed Exercise (EMADE) programme. Methods. A total of 157 patients aged 18 years or older who underwent successful open reduction and internal fixation (ORIF) of Weber B (AO44B) ankle fractures were recruited to this randomized controlled trial. At two weeks post-surgical fixation, participants were randomized to either light-weight cast-immobilization or the EMADE programme, consisting of progressive home exercises and weekly advice and education. Both groups were restricted to non-weightbearing until six weeks post-surgery. The primary outcome was assessed using the Olerud-Molander Ankle Score (OMAS) questionnaire at 12 weeks post-surgery, with secondary measures at two, six, 24, and 52 weeks. Exploratory cost-effectiveness analyses were also performed. Results. Overall, 130 participants returned their 12-week OMAS questionnaires. The mean OMAS was significantly higher in the EMADE group compared with the immobilized group (62.0 (SD 20.9) vs 48.8 (SD 22.5)), with a clinically meaningful mean difference of 13.2 (95% CI 5.66 to 20.73; p < 0.001). These differences were maintained at week 24, with convergence by week 52. No intervention-related adverse events, including instability, were reported. Conclusion. The EMADE programme demonstrated an accelerated recovery compared to traditional six-week cast immobilization for those who have undergone ORIF surgery to stabilize Weber B (AO44B) ankle fractures. The study found the EMADE intervention to be safe. Cite this article: Bone Joint J 2024;106-B(9):949–956

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. Methods. This was a single-centre, prospective cohort study involving 6,637 patients (mean age 52 years (SD 17.79)) presenting with a wide range of foot and ankle pathologies between January 2013 and December 2021. To assess whether the MOxFQ responses vary by anatomical region of foot and ankle disease, we performed multigroup confirmatory factor analysis. To assess the structural validity of the subscale items, exploratory and confirmatory factor analyses were performed. Results. Measurement invariance by pathology was confirmed, suggesting the same model can be used across all foot and ankle anatomical regions. Exploratory factor analysis demonstrated a two- to three-factor model, and suggested that item 13 (inability to carry out work/everyday activities) and item 14 (inability to undertake social/recreational activities) loaded more positively onto the “walking/standing” subscale than their original “social interaction” subscale. Conclusion. This large cohort study supports the current widespread use of the MOxFQ across a broad range of foot and ankle pathologies. Our analyses found indications that could support alterations to the original factor structure (items 13 and 14 might be moved from the “social interaction” to the “walking/standing” subscale). However, this requires further work to confirm. Cite this article: Bone Joint J 2024;106-B(3):256–261

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. Methods. A novel rat model of TTT was established with a designed external fixator, and effects on wound healing were investigated. Laser speckle perfusion imaging, vessel perfusion, histology, and immunohistochemistry were used to evaluate the wound healing processes. Results. Gross and histological examinations showed that TTT technique accelerated wound closure and enhanced the quality of the newly formed skin tissues. In the TTT group, haematoxylin and eosin (H&E) staining demonstrated a better epidermis and dermis recovery, while immunohistochemical staining showed that TTT technique promoted local collagen deposition. The TTT technique also benefited to angiogenesis and immunomodulation. In the TTT group, blood flow in the wound area was higher than that of other groups according to laser speckle imaging with more blood vessels observed. Enhanced neovascularization was seen in the TTT group with double immune-labelling of CD31 and α-Smooth Muscle Actin (α-SMA). The number of M2 macrophages at the wound site in the TTT group was also increased. Conclusion. The TTT technique accelerated wound healing through enhanced angiogenesis and immunomodulation. Cite this article: Bone Joint Res 2022;11(4):189–199

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When a total ankle arthroplasty (TAA) fails, it can be converted to a fusion or a revision arthroplasty. Despite the increasing numbers of TAAs being undertaken, there is little information in the literature about the management of patients undergoing fusion following a failed TAA. The primary aim of this study was to analyze the survival of fusions following a failed TAA using a large dataset from the National Joint Registry (NJR).

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The primary aim of this study was to present the mid-term follow-up of a multicentre randomized controlled trial (RCT) which compared the functional outcome following routine removal (RR) to the outcome following on-demand removal (ODR) of the syndesmotic screw (SS).

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A local injection may be used as an early option in the treatment of Morton’s neuroma, and can be performed using various medications. The aim of this study was to compare the effects of injections of hyaluronic acid compared with corticosteroid in the treatment of this condition.

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This study evaluated the effect of treating clinician speciality on management of zone 2 fifth metatarsal fractures.

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This scoping review aims to identify patient-related factors associated with a poorer outcome following total ankle arthroplasty (TAA).

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Osteochondral lesions of the talus (OLT) are a common cause of disability and chronic ankle pain. Many operative treatment strategies have been introduced; however, they have their own disadvantages. Recently lesion repair using autologous cartilage chip has emerged therefore we investigated the efficacy of particulated autologous cartilage transplantation (PACT) in OLT.

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The Cartiva synthetic cartilage implant (SCI) entered mainstream use in the management of first metatarsophalangeal joint (MTPJ) arthritis following the positive results of large trials in 2016. Limited information is available on the longer-term outcomes of this implant within the literature, particularly when independent from the originator. This single-centre cohort study investigates the efficacy of the Cartiva SCI at up to five years.

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The Vantage Total Ankle System is a fourth-generation low-profile fixed-bearing implant that has been available since 2016. We aimed to describe our early experience with this implant.

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Despite the increasing numbers of ankle arthroplasties, there are limited studies on their survival and comparisons between different implants. The primary aim of this study was to determine the failure rates of primary ankle arthroplasties commonly used in the UK.

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The first metatarsal pronation deformity of hallux valgus feet is widely recognized. However, its assessment relies mostly on 3D standing CT scans. Two radiological signs, the first metatarsal round head (RH) and inferior tuberosity position (ITP), have been described, but are seldom used to aid in diagnosis. This study was undertaken to determine the reliability and validity of these two signs for a more convenient and affordable preoperative assessment and postoperative comparison.

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The purpose of this study was to assess the success rate and functional outcomes of bone grafting for periprosthetic bone cysts following total ankle arthroplasty (TAA). Additionally, we evaluated the rate of graft incorporation and identified associated predisposing factors using CT scan.

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The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture.

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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.

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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.

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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.

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To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures.

Aims. In our unit, we adopt a two-stage surgical reconstruction approach using internal fixation for the management of infected Charcot foot deformity. We evaluate our experience with this functional limb salvage method. Methods. We conducted a retrospective analysis of prospectively collected data of all patients with infected Charcot foot deformity who underwent two-stage reconstruction with internal fixation between July 2011 and November 2019, with a minimum of 12 months’ follow-up. Results. We identified 23 feet in 22 patients with a mean age of 56.7 years (33 to 70). The mean postoperative follow-up period was 44.7 months (14 to 99). Limb salvage was achieved in all patients. At one-year follow-up, all ulcers have healed and independent full weightbearing mobilization was achieved in all but one patient. Seven patients developed new mechanical skin breakdown; all went on to heal following further interventions. Fusion of the hindfoot was achieved in 15 of 18 feet (83.3%). Midfoot fusion was achieved in nine of 15 patients (60%) and six had stable and painless fibrous nonunion. Hardware failure occurred in five feet, all with broken dorsomedial locking plate. Six patients required further surgery, two underwent revision surgery for infected nonunion, two for removal of metalwork and exostectomy, and two for dynamization of the hindfoot nail. Conclusion. Two-stage reconstruction of the infected and deformed Charcot foot using internal fixation and following the principle of ‘long-segment, rigid and durable internal fixation, with optimal bone opposition and local antibiotic elusion’ is a good form of treatment provided a multidisciplinary care plan is delivered. Cite this article: Bone Joint J 2021;103-B(10):1611–1618

Aims. The primary objective was to determine the incidence of COVID-19 infection and 30-day mortality in patients undergoing foot and ankle surgery during the global pandemic. Secondary objectives were to determine if there was a change in infection and complication profile with changes introduced in practice. Methods. This UK-based multicentre retrospective national audit studied foot and ankle patients who underwent surgery between 13 January and 31 July 2020, examining time periods pre-UK national lockdown, during lockdown (23 March to 11 May 2020), and post-lockdown. All adult patients undergoing foot and ankle surgery in an operating theatre during the study period were included. A total of 43 centres in England, Scotland, Wales, and Northern Ireland participated. Variables recorded included demographic data, surgical data, comorbidity data, COVID-19 and mortality rates, complications, and infection rates. Results. A total of 6,644 patients were included. Of the operated patients, 0.52% (n = 35) contracted COVID-19. The overall all-cause 30-day mortality rate was 0.41%, however in patients who contracted COVID-19, the mortality rate was 25.71% (n = 9); this was significantly higher for patients undergoing diabetic foot surgery (75%, n = 3 deaths). Matching for age, American Society of Anesthesiologists (ASA) grade, and comorbidities, the odds ratio of mortality with COVID-19 infection was 11.71 (95% confidence interval 1.55 to 88.74; p = 0.017). There were no differences in surgical complications or infection rates prior to or after lockdown, and among patients with and without COVID-19 infection. After lockdown the COVID-19 infection rate was 0.15% and no patient died of COVID-19. Conclusion. COVID-19 infection was rare in foot and ankle patients even at the peak of lockdown. However, there was a significant mortality rate in those who contracted COVID-19. Overall surgical complications and postoperative infection rates remained unchanged during the period of this audit. Patients and treating medical personnel should be aware of the risks to enable informed decisions. Cite this article: Bone Joint Open 2021;2(4):216–226

Aims. We report the medium-term outcomes of a consecutive series of 118 Zenith total ankle arthroplasties (TAAs) from a single, non-designer centre. Methods. Between December 2010 and May 2016, 118 consecutive Zenith prostheses were implanted in 114 patients. Demographic, clinical, and patient-reported outcome measures (PROMs) data were collected. The endpoint of the study was failure of the implant requiring revision of one or all of the components. Kaplan-Meier survival curves were generated with 95% confidence intervals (CIs) and the rate of failure calculated for each year. Results. Eight patients (ten ankles) died during follow-up, but none required revision. Of the surviving 106 patients (108 ankles: rheumatoid arthritis (RA), n = 15; osteoarthritis (OA), n = 93), 38 were women and 68 were men, with a mean age of 68.2 years (48 to 86) at the time of surgery. Mean follow-up was 5.1 years (2.1 to 9.0). A total of ten implants failed (8.5%), thus requiring revision. The implant survival at seven years, using revision as an endpoint, was 88.2% (95% CI 100% to 72.9%). There was a mean improvement in Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ) from 85.0 to 32.8 and visual analogue scale (VAS) scores from 7.0 to 3.2, and overall satisfaction was 89%. The three commonest complications were malleolar fracture (14.4%, n = 17), wound healing (13.6%, n = 16), and superficial infection (12.7%, n = 15). The commonest reason for revision was aseptic loosening. No patients in our study were revised for deep infection. Conclusion. Our results show that Zenith survival rates are comparable with those in the literature for other implants and in the National Joint Registry (NJR). Overall patient satisfaction was high as were functional outcomes. However, the data highlight potential complications associated with this surgery. The authors believe that these figures support ankle arthroplasty as an option in the treatment of ankle arthritis. Cite this article: Bone Joint J 2021;103-B(4):696–703

Aims. This is a multicentre, non-inventor, prospective observational study of 503 INFINITY fixed bearing total ankle arthroplasties (TAAs). We report our early experience, complications, and radiological and functional outcomes. Methods. Patients were recruited from 11 specialist centres between June 2016 and November 2019. Demographic, radiological, and functional outcome data (Ankle Osteoarthritis Scale, Manchester Oxford Questionnaire, and EuroQol five-dimension five-level score) were collected preoperatively, at six months, one year, and two years. The Canadian Orthopaedic Foot and Ankle Society (COFAS) grading system was used to stratify deformity. Early and late complications and reoperations were recorded as adverse events. Radiographs were assessed for lucencies, cysts, and/or subsidence. Results. In all, 500 patients reached six-month follow-up, 420 reached one-year follow-up, and 188 reached two-year follow-up. The mean age was 67.8 years (23.9 to 88.5). A total of 38 patients (7.5%) presented with inflammatory arthritis. A total of 101 (20.0%) of implantations used patient-specific instrumentation; 167 patients (33.1%) underwent an additional procedure at the time of surgery. A total of seven patients died of unrelated causes, two withdrew, and one was lost to follow-up. The mean follow-up was 16.2 months (6 to 36). There was a significant improvement from baseline across all functional outcome scores at six months, one, and two years. There was no significant difference in outcomes with the use of patient-specific instrumentation, type of arthritis, or COFAS type. Five (1.0%) implants were revised. The overall complication rate was 8.8%. The non-revision reoperation rate was 1.4%. The 30-day readmission rate was 1.2% and the one-year mortality 0.74%. Conclusion. The early experience and complications reported in this study support the current use of the INFINITY TAA as a safe and effective implant in the treatment of end-stage ankle arthritis. Cite this article: Bone Joint J 2021;103-B(7):1270–1276

Aims. To assess the characteristic clinical features, management, and outcome of patients who present to orthopaedic surgeons with functional dystonia affecting the foot and ankle. Methods. We carried out a retrospective search of our records from 2000 to 2019 of patients seen in our adult tertiary referral foot and ankle unit with a diagnosis of functional dystonia. Results. A total of 29 patients were seen. A majority were female (n = 25) and the mean age of onset of symptoms was 35.3 years (13 to 71). The mean delay between onset and diagnosis was 7.1 years (0.5 to 25.0). Onset was acute in 25 patients and insidious in four. Of the 29 patients, 26 had a fixed dystonia and three had a spasmodic dystonia. Pain was a major symptom in all patients, with a coexisting diagnosis of chronic regional pain syndrome (CRPS) made in nine patients. Of 20 patients treated with Botox, only one had a good response. None of the 12 patients who underwent a surgical intervention at our unit or elsewhere reported a subjective overall improvement. After a mean follow-up of 3.2 years (1 to 12), four patients had improved, 17 had remained the same, and eight reported a deterioration in their condition. Conclusion. Patients with functional dystonia typically presented with a rapid onset of fixed deformity after a minor injury/event and pain out of proportion to the deformity. Referral to a neurologist to rule out neurological pathology is advocated, and further management should be carried out in a movement disorder clinic. Response to treatment (including Botulinum toxin (Botox) injections) is generally poor. Surgery in this group of patients is not recommended and may worsen the condition. The overall prognosis remains poor. Cite this article: Bone Joint J 2021;103-B(6):1127–1132

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Surgical reconstruction of deformed Charcot feet carries a high risk of nonunion, metalwork failure, and deformity recurrence. The primary aim of this study was to identify the factors contributing to these complications following hindfoot Charcot reconstructions.

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To compare the cost-utility of removable brace compared with cast in the management of adult patients with ankle fracture.

Aims. Functional rehabilitation has become an increasingly popular treatment for Achilles tendon rupture (ATR), providing comparably low re-rupture rates to surgery, while avoiding risks of surgical complications. Limited evidence exists on whether gap size should affect patient selection for this treatment option. The aim of this study was to assess if size of gap between ruptured tendon ends affects patient-reported outcome following ATR treated with functional rehabilitation. Methods. Analysis of prospectively collected data on all 131 patients diagnosed with ATR at Royal Berkshire Hospital, UK, from August 2016 to January 2019 and managed non-operatively was performed. Diagnosis was confirmed on all patients by dynamic ultrasound scanning and gap size measured with ankle in full plantarflexion. Functional rehabilitation using an established protocol was the preferred treatment. All non-operatively treated patients with completed Achilles Tendon Rupture Scores (ATRS) at a minimum of 12 months following injury were included. Results. In all, 82 patients with completed ATRS were included in the analysis. Their mean age was 51 years (standard deviation (SD) 14). The mean ATRS was 76 (SD 19) at a mean follow-up of 20 months (SD 11) following injury. Gap inversely affected ATRS with a Pearson’s correlation of -0.30 (p = 0.008). Mean ATRS was lower with gaps > 5 mm compared with ≤ 5 mm (73 (SD 21) vs 82 (SD 16); p = 0.031). Mean ATRS was lowest (70 (SD 23)) with gaps > 10 mm, with significant differences in perceived strength and pain. The overall re-rupture rate was two out of 131 (1.5%). Conclusion. Increasing gap size predicts lower patient-reported outcome, as measured by ATRS. Tendon gap > 5 mm may be a useful predictor in physically demanding individuals, and tendon gap > 10 mm for those with low physical demand. Further studies that control for gap size when comparing non-operative and operative treatment are required to assess if these patients may benefit from surgery, particularly when balanced against the surgical risks. Cite this article: Bone Joint J 2020;102-B(11):1535–1541