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

Aims. Total ankle arthroplasty (TAA) surgery is complex and attracts a wide variety of complications. The literature lacks consistency in reporting adverse events and complications. The aim of this article is to provide a comprehensive analysis of each of these complications from a literature review, and to compare them with rates from our Unit, to aid clinicians with the process of informed consent. Patients and Methods. A total of 278 consecutive total ankle arthroplasties (251 patients), performed by four surgeons over a six-year period in Wrightington Hospital (Wigan, United Kingdom) were prospectively reviewed. There were 143 men and 108 women with a mean age of 64 years (41 to 86). The data were recorded on each follow-up visit. Any complications either during initial hospital stay or subsequently reported on follow-ups were recorded, investigated, monitored, and treated as warranted. Literature search included the studies reporting the outcomes and complications of TAA implants. Results. There were wound-healing problems in nine ankles (3.2%), superficial infection in 20 ankles (7.2%), and deep infection in six ankles (2.2%). Intraoperative fractures occurred in medial malleoli in 27 ankles (9.7%) and in lateral malleoli in four ankles (1.4%). Aseptic loosening and osteolysis were seen 16 ankles (5.8%). Fracture of the polyethylene component occurred in one ankle (0.4%) and edge-loading in seven ankles (2.5%). We observed medial gutter pain in 31 ankles (11.1%). The incidence of thromboembolism occurred in two ankles (0.7%). The results were found to be comparable to the previously reported complications of total ankle arthroplasty in the literature. Conclusion. Total ankle arthroplasty continues to evolve and improve the ankle function. Despite high overall complication rates with TAA surgery, most complications appear to be minor and do not affect final clinical outcome. Our results and literature review will help in the consent process and provide detailed complication rates for an informed consent. Cite this article: Bone Joint J 2018;100-B:1352–8

Introduction:. The aim of this study was to identify the rate of complications of total ankle replacement in a single Centre to help with informed patient consent. Methods:. Between 2008 and 2012, 202 total ankle replacements (TARs) were performed by 4 surgeons at our Institute. Data was collected on all patients; demographics, arthritic disease, pre-operative deformity, prosthesis and all early and late complications. Results:. 4 surgeons (A, B, C, D) performed 63, 55, 48 and 36 TARs (178 De Puy Mobility and 24 Corin Zenith). 130 patients had primary osteoarthrosis, 35 had rheumatoid and 36 had post traumatic osteoarthrosis. There were no differences in patient demographics for each surgeon. There were 3 deep infections (A, B, C, D: 1,0,2,0). There were 18 medial malleolar fractures (8 intra-operative [4,1,1,2], 3 early (< 3 months) [1,1,0,1] and 7 late (> 3 months) [2,2,2,1]). There were 2 lateral malleolar fractures, both intra-operative (0,0,1,1). There were 15 patients who developed superficial wound infections, which resolved fully with oral antibiotics (4,3,4,4). A further 7 patients had a delay to wound healing (wound not fully healed at 3 months) (4,0,2,1); 2 of these developed deep infection and failed. 22 patients had persistent medial gutter pain (9,4,5,4); all had undergone Mobility TAR. 4 patients developed recurrent edge loading and have had to be revised (4 converted to TTC fusion) (2,0,2,0). We report complications in 32% of patients. Overall 9 TARs failed and underwent revision to fusion (2,2,5,0). Conclusion:. We report an overall complication rate of 32% following TARs, however most are minor and don't affect clinical outcome. We had a 1.5% deep infection rate. Complication rates were comparable between 4 surgeons. There was a difference in medial gutter pain rate between implants (13% v 0% Mobility to Zenith). This data provides detailed complication rates for informed consent

Informed consent is integral to good-practice. It protects the patient and offers proof of discussion and interaction between the surgeon and the patient. We compare efficacy of last clinic consent, specialised consent clinic with or without provision of patient specific literature. Group A patients underwent written consent at their last outpatient clinic and conformation of consent on the morning of surgery. Group B underwent consent in designated pre-admission clinic in the week prior to surgery. Group (C) attended the same preadmission clinic and were provided with a surgeon dictated written explanation of their surgery and particular risks. This included a explanation of the procedure, complications, risks and rewards in layman's terms, aimed at patients with a reading age of 14 years, with advice concerning alternative procedures and the consequences of taking no action. The risks are graded: common, less common and rare. All patients undertook a pre-surgery questionnaire on the morning of surgery by an independent observer prior to any contact with the surgical team. Questions focused on their planed procedure, post-operative instructions and possible complications in order to assess the recall of the consent process. A VAS-scale was added to assess overall satisfaction. Statistical analysis was undertaken by a T-test. In total 162-patients were assessed, the response rate was 68.5% (n=111). In-group A (n=16) 18.8% patients remembered 3 relevant complications, 56.2% recalled their post-operative considerations their overall satisfaction was 4/10. In-group B (n=57) 45.5% remembered three complications, 63.7% recalled their postoperative considerations and had a patient satisfaction of 5/10. In-group C (n=38) 48.3% remembered three complications, and 70.7% recalled postoperative considerations, the overall satisfaction improved to 6/10. We observed that the consent process is improved by the use of routine pre-operative consent clinics; however the addition of patient specific literature is observed to further improve recall and satisfaction

Total ankle replacement (TAR) is increasingly offered as an alternative to ankle fusion for the management of severe ankle arthritis. As with all other types of joint arthroplasty, there are risks involved and complications that occur; these increase with case complexity. We present the complications and management from a single-centre series. Since 2006, we have performed 150 Mobility TARs with up to 4 years' follow-up. We have excluded 16 that are part of a separate RCT and 10 with less than 3 months' follow-up. 124 TARs were included in our study (117 patients). Three ankles (2.4%) had superficial wound infections treated successfully with antibiotics. One ankle (0.8%) required an arthroscopic washout and debridement but the implant was retained. 11 ankles (8.9%) had a periprosthetic fracture: One was intraoperative; 10 were postoperative (2 fixed). Four patients (3.2%) developed CRPS. One ankle required fusion surgery (following subsidence of the talar component) with another one pending revision (ligament instability causing implant displacement). No patient had a symptomatic deep vein thrombosis or thromboembolic event. Our figures are comparable with other series. Our complication rate has not changed significantly over time. Our results, at present, suggest that most complications (98%) with the Mobility TAR can be satisfactorily managed without having a detrimental effect on the implant. There have been proven and promising results with total ankle replacement. However, there is a significant complication rate that must be made clear to the patient via informed consent; the rate still remains higher than for hip and knee arthroplasty

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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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Arthroscopic microfracture is a conventional form of treatment for patients with osteochondritis of the talus, involving an area of < 1.5 cm². 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.

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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 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.

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To evaluate how fore- and midfoot coronal plane alignment differs in feet with hallux valgus (HV), using 3DCT when measured in standard weightbearing (SWB) versus sesamoid view (SV) position, and to determine whether first metatarsophalangeal (MTP) dorsiflexion affects the relationship between the first metatarsal (M1) head and the sesamoid bones.

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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.

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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.

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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.

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We report the medium-term outcomes of a consecutive series of 118 Zenith total ankle arthroplasties (TAAs) from a single, non-designer centre.

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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.

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Arthroplasty has become increasingly popular to treat end-stage ankle arthritis. Iatrogenic posterior neurovascular and tendinous injury have been described from saw cuts. However, it is hypothesized that posterior ankle structures could be damaged by inserting tibial guide pins too deeply and be a potential cause of residual hindfoot pain.

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Preoperative talar valgus deformity ≥ 15° is considered a contraindication for total ankle arthroplasty (TAA). We compared operative procedures and clinical outcomes of TAA in patients with talar valgus deformity ≥ 15° and < 15°.

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The hypothesis of this study was that bone peg fixation in the treatment of osteochondral lesions of the talus would show satisfactory clinical and radiological results, without complications.

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To assess the effect of age on clinical outcome and revision rates in patients who underwent total ankle arthroplasty (TAA) for end-stage ankle osteoarthritis (OA).

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To evaluate the donor site morbidity and tendon morphology after harvesting whole length, full-thickness peroneus longus tendon (PLT) proximal to the lateral malleolus for ligament reconstructions or tendon transfer.