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Bone & Joint Open
Vol. 2, Issue 8 | Pages 631 - 637
10 Aug 2021
Realpe AX Blackstone J Griffin DR Bing AJF Karski M Milner SA Siddique M Goldberg A

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


Bone & Joint Open
Vol. 3, Issue 10 | Pages 832 - 840
24 Oct 2022
Pearson NA Tutton E Joeris A Gwilym SE Grant R Keene DJ Haywood KL

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


Bone & Joint Open
Vol. 3, Issue 8 | Pages 618 - 622
1 Aug 2022
Robinson AHN Garg P Kirmani S Allen P

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


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 382 - 388
15 Mar 2023
Haque A Parsons H Parsons N Costa ML Redmond AC Mason J Nwankwo H Kearney RS

Aims

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.

Methods

This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years.


Bone & Joint Open
Vol. 4, Issue 3 | Pages 188 - 197
15 Mar 2023
Pearson NA Tutton E Gwilym SE Joeris A Grant R Keene DJ Haywood KL

Aims

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

Methods

We undertook a systematic review of qualitative studies. Five databases were searched from inception to 1 February 2022. All titles and abstracts were screened, and a subset were independently assessed. Methodological quality was appraised using the Critical Appraisal Skills Programme (CASP) checklist. The GRADE-CERQual checklist was used to assign confidence ratings. Thematic synthesis was used to analyze data with the identification of codes which were drawn together to form subthemes and then themes.


The Bone & Joint Journal
Vol. 98-B, Issue 4 | Pages 498 - 503
1 Apr 2016
Mahadevan D Attwal M Bhatt R Bhatia M

Aims. The objective of this double-blind randomised controlled trial was to assess whether ultrasound guidance improved the efficacy of corticosteroid injections for Morton’s neuroma (MN). . Patients and Methods. In all, 50 feet (40 patients) were recruited for this study but five feet were excluded due to the patients declining further participation. The mean age of the remaining 36 patients (45 feet) was 57.8 years (standard deviation (. sd. ) 12.9) with a female preponderance (33F:12M). All patients were followed-up for 12 months. Treatment was randomised to an ultrasound guided (Group A) or non-ultrasound guided (Group B) injection of 40 mg triamcinolone acetonide and 2 ml 1% lignocaine, following ultrasound confirmation of the diagnosis. . Results. The mean visual analogue score for pain improved significantly in both groups (Group A – from 64 mm, . sd. 25 mm to 29 mm, . sd. 27; Group B – from 69 mm, . sd. 23 mm to 37 mm, . sd. 25) with no statistical difference between them at all time-points. The failure rate within 12 months of treatment was 11/23 (48%) and 12/22 (55%) in Groups A and B, respectively (p = 0.458). The improvement in Manchester Oxford Foot Questionnaire Index and patient satisfaction favoured Group A in the short-term (three months) that almost reached statistical significance (p = 0.059 and 0.066 respectively). However, this difference was not observed beyond three months. . Conclusion. This study has shown that ultrasound guidance did not demonstrably improve the efficacy of corticosteroid injections in patients with MN. Take home message: In the presence of a clear diagnosis of MN, a trained clinician who understands the forefoot anatomy may perform an injection without ultrasound guidance with good and safe results. Cite this article: Bone Joint J 2016;98-B:498–503


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 68 - 75
1 Jan 2022
Harris NJ Nicholson G Pountos I

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.

Methods

Data on a consecutive group of elite athletes who underwent isolated reconstruction of the anterior inferior tibiofibular ligament using the InternalBrace were collected prospectively. Our patient group consisted of 19 elite male athletes with a mean age of 24.5 years (17 to 52). Isolated injuries were seen in 12 patients while associated injuries were found in seven patients (fibular fracture, medial malleolus fracture, anterior talofibular ligament rupture, and posterior malleolus fracture). All patients had a minimum follow-up period of 17 months (mean 27 months (17 to 35)).


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 7 | Pages 954 - 957
1 Jul 2010
Mann HA Myerson MS

We describe five adolescent patients aged between 13 and 16 years with bipartite ossification of the posteromedial aspect of the talus. All presented without a history of trauma. All the ankles had a similar radiological appearance. Clinically, some restriction of movement was noted in three ankles and two subtalar joints, In addition, pain was noted over the posteromedial aspect of the ankle in three patients. In each patient the bipartite fragment was excised through a posteromedial approach to the ankle. Complete resolution was achieved at six months in three patients, with the remaining two describing exercise-induced symptoms. In one of these this precluded participation in sport. Despite numerous anatomical variations within the tarsus, a case series of a bipartite talus has not previously been reported. This anatomical variation should be recognised to avoid misinterpretation as post-traumatic or other pathological processes. In the presence of recalcitrant symptoms excision is an option, but this is not universally successful in abolishing symptoms


The Bone & Joint Journal
Vol. 103-B, Issue 11 | Pages 1709 - 1716
1 Nov 2021
Sanders FRK Birnie MF Dingemans SA van den Bekerom MPJ Parkkinen M van Veen RN Goslings JC Schepers T

Aims

The aim of this study was to investigate whether on-demand removal (ODR) is noninferior to routine removal (RR) of syndesmotic screws regarding functional outcome.

Methods

Adult patients (aged above 17 years) with traumatic syndesmotic injury, surgically treated within 14 days of trauma using one or two syndesmotic screws, were eligible (n = 490) for inclusion in this randomized controlled noninferiority trial. A total of 197 patients were randomized for either ODR (retaining the syndesmotic screw unless there were complaints warranting removal) or RR (screw removed at eight to 12 weeks after syndesmotic fixation), of whom 152 completed the study. The primary outcome was functional outcome at 12 months after screw placement, measured by the Olerud-Molander Ankle Score (OMAS).


Bone & Joint Open
Vol. 2, Issue 3 | Pages 150 - 163
1 Mar 2021
Flett L Adamson J Barron E Brealey S Corbacho B Costa ML Gedney G Giotakis N Hewitt C Hugill-Jones J Hukins D Keding A McDaid C Mitchell A Northgraves M O'Carroll G Parker A Scantlebury A Stobbart L Torgerson D Turner E Welch C Sharma H

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.

Methods

A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.


The Bone & Joint Journal
Vol. 98-B, Issue 10 | Pages 1299 - 1311
1 Oct 2016
Hong CC Pearce CJ Ballal MS Calder JDF

Injuries to the foot in athletes are often subtle and can lead to a substantial loss of function if not diagnosed and treated appropriately. For these injuries in general, even after a diagnosis is made, treatment options are controversial and become even more so in high level athletes where limiting the time away from training and competition is a significant consideration.

In this review, we cover some of the common and important sporting injuries affecting the foot including updates on their management and outcomes.

Cite this article: Bone Joint J 2016;98-B:1299–1311.


The Bone & Joint Journal
Vol. 95-B, Issue 2 | Pages 192 - 198
1 Feb 2013
Ackman J Altiok H Flanagan A Peer M Graf A Krzak J Hassani S Eastwood D Harris GF

Van Nes rotationplasty may be used for patients with congenital proximal focal femoral deficiency (PFFD). The lower limb is rotated to use the ankle and foot as a functional knee joint within a prosthesis. A small series of cases was investigated to determine the long-term outcome. At a mean of 21.5 years (11 to 45) after their rotationplasty, a total of 12 prosthetic patients completed the Short-Form (SF)-36, Faces Pain Scale-Revised, Harris hip score, Oswestry back pain score and Prosthetic Evaluation Questionnaires, as did 12 age- and gender-matched normal control participants. A physical examination and gait analysis, computerised dynamic posturography (CDP), and timed ‘Up & Go’ testing was also completed. Wilcoxon Signed rank test was used to compare each PFFD patient with a matched control participant with false discovery rate of 5%.

There were no differences between the groups in overall health and well-being on the SF-36. Significant differences were seen in gait parameters in the PFFD group. Using CDP, the PFFD group had reduced symmetry in stance, and reduced end point and maximum excursions.

Patients who had undergone Van Nes rotationplasty had a high level of function and quality of life at long-term follow-up, but presented with significant differences in gait and posture compared with the control group.

Cite this article: Bone Joint J 2013;95-B:192–8.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 11 | Pages 1522 - 1528
1 Nov 2012
Wallander H Saebö M Jonsson K Bjönness T Hansson G

We investigated 60 patients (89 feet) with a mean age of 64 years (61 to 67) treated for congenital clubfoot deformity, using standardised weight-bearing radiographs of both feet and ankles together with a functional evaluation. Talocalcaneal and talonavicular relationships were measured and the degree of osteo-arthritic change in the ankle and talonavicular joints was assessed. The functional results were evaluated using a modified Laaveg-Ponseti score. The talocalcaneal (TC) angles in the clubfeet were significantly lower in both anteroposterior (AP) and lateral projections than in the unaffected feet (p < 0.001 for both views). There was significant medial subluxation of the navicular in the clubfeet compared with the unaffected feet (p < 0.001). Severe osteoarthritis in the ankle joint was seen in seven feet (8%) and in the talonavicular joint in 11 feet (12%). The functional result was excellent or good (≥ 80 points) in 29 patients (48%), and fair or poor (< 80 points) in 31 patients (52%). Patients who had undergone few (0 to 1) surgical procedures had better functional outcomes than those who had undergone two or more procedures (p < 0.001). There was a significant correlation between the functional result and the degree of medial subluxation of the navicular (p < 0.001, r2 = 0.164), the talocalcaneal angle on AP projection (p < 0.02, r2 = 0.025) and extent of osteoarthritis in the ankle joint (p < 0.001).

We conclude that poor functional outcome in patients with congenital clubfoot occurs more frequently in those with medial displacement of the navicular, osteoarthritis of the talonavicular and ankle joints, and a low talocalcaneal angle on the AP projection, and in patients who have undergone two or more surgical procedures. However, the ankle joint in these patients appeared relatively resistant to the development of osteoarthritis.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 10 | Pages 1316 - 1321
1 Oct 2009
Wallander H Larsson S Bjönness T Hansson G

The outcome in 83 patients with congenital clubfoot was evaluated at a mean age of 64 years using three validated questionnaires assessing both quality of life (short-form (SF)-36 and EQ-5D) and foot and ankle function (American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle questionnaire). In SF-36, male patients scored significantly better than male norms in seven of the eight domains, whereas female patients scored significantly worse than female norms in two of the eight. Male patients scored better than male norms in both the EQ-5D index (p = 0.027) and visual analogue scale (VAS) (p = 0.013), whereas female patients scored worse than female norms in the VAS (p < 0.001). Both male and female patients had a significantly worse outcome on the AAOS Core Scale than did norms. There was a significant correlation for both genders between the SF-36 Physical Component Summary Score and the AAOS Core Scale.

The influence on activities of daily life was limited to foot and ankle problems in all patients, and in females there was an adverse effect in physical aspects of quality of life.


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 11 | Pages 1451 - 1456
1 Nov 2008
Morris C Doll HA Wainwright A Theologis T Fitzpatrick R

We developed the Oxford ankle foot questionnaire to assess the disability associated with foot and ankle problems in children aged from five to 16 years. A survey of 158 children and their parents was carried out to determine the content, scaling, reliability and validity of the instrument. Scores from the questionnaire can be calculated to measure the effect of foot or ankle problems on three domains of children’s lives: physical, school and play, and emotional. Scores for each domain were shown to be internally consistent, stable, and to vary little whether reported by child or parent. Satisfactory face, content and construct validity were demonstrated. The questionnaire is appropriate for children with a range of conditions and can provide clinically useful information to supplement other assessment methods. We are currently carrying out further work to assess the responsiveness of questionnaire scores to change over time and with treatment.