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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


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.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1249 - 1256
1 Nov 2024
Mangwani J Houchen-Wolloff L Malhotra K Booth S Smith A Teece L Mason LW

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.


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 895 - 904
1 Aug 2023
Smith TO Dainty J Loveday DT Toms A Goldberg AJ Watts L Pennington MW Dawson J van der Meulen J MacGregor AJ

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.


Bone & Joint Open
Vol. 3, Issue 6 | Pages 455 - 462
6 Jun 2022
Nwankwo H Mason J Costa ML Parsons N Redmond A Parsons H Haque A Kearney RS

Aims

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

Methods

A within-trial economic evaluation conducted from the UK NHS and personnel social services (PSS) perspective. Health resources and quality-of-life data were collected as part of the Ankle Injury Rehabilitation (AIR) multicentre, randomized controlled trial over a 12-month period using trial case report forms and patient-completed questionnaires. Cost-utility analysis was estimated in terms of the incremental cost per quality adjusted life year (QALY) gained. Estimate uncertainty was explored by bootstrapping, visualized on the incremental cost-effectiveness ratio plane. Net monetary benefit and probability of cost-effectiveness were evaluated at a range of willingness-to-pay thresholds and visualized graphically.


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 703 - 708
1 Jun 2022
Najefi A Zaidi R Chan O Hester T Kavarthapu V

Aims

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.

Methods

We retrospectively analyzed patients who underwent hindfoot Charcot reconstruction with an intramedullary nail between January 2007 and December 2019 in our unit. Patient demographic details, comorbidities, weightbearing status, and postoperative complications were noted. Metalwork breakage, nonunion, deformity recurrence, concurrent midfoot reconstruction, and the measurements related to intramedullary nail were also recorded.


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.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_19 | Pages 23 - 23
1 Nov 2016
Johnson-Lynn S Cooney A Ferguson D Bunn D Gray W Coorsh J Kakwani R Townshend D
Full Access

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


The Bone & Joint Journal
Vol. 103-B, Issue 6 | Pages 1127 - 1132
1 Jun 2021
Gray J Welck M Cullen NP Singh D

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.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_2 | Pages 18 - 18
1 Jan 2014
Perera A Beddard L Marudunayagam A
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Background:. Previous attempts at small incision hallux valgus surgery have compromised the principles of bunion correction in order to minimise the incision. The Minimally Invasive Chevron/Akin (MICA) is a technique that enables an open modified Chevron/Akin to be done through a 3 mm incision, facilitated by a 2 mm Shannon burr. Methodology:. This is a consecutive case series performed between 2009 and 2012. This includes the learning curve for minimally invasive surgery. All cases were performed by a single surgeon at two different sites, one centre where minimally invasive surgery is available and the other where it is not. The standard procedure in both centres is a modified Chevron osteotomy. Regardless of whether the osteotomy was performed open or minimally invasive two-screw fixation was performed. Retrospective analysis includes the IMA, HVA, M1 length, forefoot width and forefoot: hindfoot ratio. Clinical outcomes include the MOXFQ, AOFAS, and assessment of complications. Results:. There were 70 cases in each arm. Follow-up was 4 years to 6 months. The radiological outcomes were similar in both groups. There was an increased rate of screw removal in the MICA group. There were also cases of hallux varus, these occurred in the cases with severe pre-operative IMA angles that also had a lateral release and an Akin. There was high satisfaction in both groups. Conclusion:. This is the only comparison of minimally invasive and open techniques that has been performed, providing a direct comparison of the utility of a burr compared to a saw. These early results demonstrate the efficacy of a Minimally Invasive Chevron/Akin in terms of achieving radiological correction. The clinical outcomes are excellent but there is a learning curve and this needs to be managed


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_21 | Pages 8 - 8
1 Apr 2013
Perera A Helguera-Mendoza O Myerson M
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Background. The Weil osteotomy is successful in the management of metatarsalgia and toe deformity. The aim is to achieve controlled shortening whilst avoiding plantarflexion. Recognised complications of the Weil osteotomy include a ‘floating toe’ in up to 20% or more of cases. Aim. Can modification of the Weil osteotomy avoid the metatarsal head plantarflexion and subsequent dorsal subluxation of the interosseous muscle that is implicated in the development of a ‘floating toe’. Methodology. The 2nd, 3rd and 4th rays were dissected out en bloc with all tendons attached from 6 pairs of fresh frozen cadavers. The ray was fixed to a board and the tendons physiologically balanced via low-friction pulleys and light weights. This model is highly sensitive to alterations in moment arm of the tendons. Once the MTP joint was balanced these weights were not altered. After standard release of the dorsal capsule a Maceira or ‘triple-cut’ osteotomy was performed. This osteotomy was developed in order to permit shortening without plantar flexion of the metatarsal head. The osteotomy was performed using a image intensifier in order to maintain uniformity of the osteotomy cut. The neck was shortened by removing a 2mm slice of bone made with parallel cuts. The ray was photographed and x-rayed pre and post ‘surgery’ and the relationships of the interosseous tendon andcentre of rotation of the metatarsal head, tendon balance and toe posture were recorded. Results. The Maceira osteotomy can avoid plantarflexion of the metatarsal head The line of pull of the interosseous tendon can maintains it's normal relationship with the centre of rotation of the metatarsal head. None of the toes developed dorsiflexion. In fact, plantarflexion at the MTP joint could be seen. PIP ‘fusion’ resulted in dorsiflexion at the MTP joint in some toes


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_2 | Pages 34 - 34
1 Jan 2014
Refaie R Chong M Murty A Reed M
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Introduction:. Symptomatic treatment of ankle osteoarthritis (OA) with corticosteroid injections is well established. Hyaluronic acid is also reported as an effective symptomatic treatment for ankle OA but these two treatments have not been compared directly. Methods:. A prospective randomised controlled trial in patients with symptomatic ankle osteoarthritis. Twenty patients per group were required based on a significance level of 0.05, and a drop out rate of 5%. Patients were blindly allocated to the treatment or control group. Injections were carried out by the clinician in the outpatient department. Treatment group received Ostenil 20 mg and control group received Depomedrone 40 mg (both as single injections). The treatment arm was allocated by computer generated block randomization to match treatment allocation with grade of arthritis. The primary outcome measure was the change in Visual Analogue Scale (VAS) pain score at 6 months. Secondary outcome was the change in AOFAS score at 6 months. Research ethics committee approval was obtained. Results:. A total of 42 patients were recruited of which 38 completed the study. Male recruits predominated (79%; 33 recruits). More than 70% had radiographic OA of grade 3 or more. Both groups demonstrated statistically significant improvements in VAS at weeks 3, 6, and 3 months over baseline, but the Ostenil group faired better at 6 months follow-up. (difference in VAS scores of 3.5 Ostenil VAS − 4; Steroid VAS − 7.5; Mann Whitney test (p<=0.05). There was no statistical difference in AOFAS scores between both groups at baseline and follow-up (p=0.48, Mann Whitney test). No complications noted. 30% of patients have had their surgical procedures delayed for 6 month post injection. Conclusion:. The Ostenil group revealed similar clinical efficacy to steroid group, however the benefits provided by Ostenil lasted longer. Ostenil provided sufficient mid-term pain-relief whilst patient awaits further definitive intervention


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIII | Pages 38 - 38
1 Sep 2012
Ramaskandhan JR Bettinson K Siddique M
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This project highlights the red flags in postoperative rehabilitation of total ankle replacement (TAR) patients managed with two different postoperative rehab regimes. 20 TAR patients were recruited for a pilot RCT between 2008 and 2011; they were randomized to 2 groups (immobilisation in a below knee plaster cast for 6 weeks vs. early mobilisation following TAR); all patients underwent a graded outpatient Physiotherapy program until 12 weeks postoperatively. Assessments included questionnaires, complications, American Orthopaedic Foot and Ankle Score (AOFAS) done preoperatively, 3 and 6 months after surgery. Results. 20 TARs for OA (13) and PTOA (7) took part in the trial. There were 10 patients in each arm of the study. Mean age 61.2 years; mean BMI was 29.4. Of the plaster group, there was 1 incidence of fracture medial malleolus (MM) at 6 weeks after removal of plaster cast, 1 fracture MM at 5 months following walking on the beach, 1 fracture (MM) after completion of outpatient physiotherapy session, and 1 fracture MM of unknown reason at 1 year. Of the early mobilisation group, there was 1 intraoperative fracture of tibia (treated conservatively); 1 fracture MM 6 weeks post-op; 2 fracture MM at 8 weeks post-op. All patients had good clinical outcomes at successive follow up assessments. Conclusion. These results highlights the need for considering a lighter exercise regime, and re-evaluating patient lifestyle, return to recreational activities and feedback on home exercise programs during planning and execution of each phase of postoperative rehabilitation programs to aid prevention of early fractures in patients following TAR


The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 933 - 940
1 Jul 2020
Maempel JF Clement ND Wickramasinghe NR Duckworth AD Keating JF

Aims

The aim was to compare long-term patient-reported outcome measures (PROMs) after operative and nonoperative treatment of acute Achilles tendon rupture in the context of a randomized controlled trial.

Methods

PROMs including the Short Musculoskeletal Function Assessment (SMFA), Achilles Tendon Total Rupture Score (ATRS), EuroQol five-dimension (EQ-5D), satisfaction, net promoter score and data regarding re-rupture, and venous thromboembolic rates were collected for patients randomized to receive either operative or nonoperative treatment for acute Achilles tendon rupture in a previous study. Of the 80 patients originally randomized, 64 (33 treated surgically, 31 nonoperatively) patients were followed up at a mean of 15.7 years (13.4 to 17.7).


The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 7 | Pages 981 - 985
1 Sep 2002
Peicha G Labovitz J Seibert FJ Grechenig W Weiglein A Preidler KW Quehenberger F

The anatomy of the mortise of the Lisfranc joint between the medial and lateral cuneiforms was studied in detail, with particular reference to features which may predispose to injury. In 33 consecutive patients with Lisfranc injuries we measured, from conventional radiographs, the medial depth of the mortise (A), the lateral depth (B) and the length of the second metatarsal (C). MRI was used to confirm the diagnosis. We calculated the mean depth of the mortise (A+B)/2, and the variables of the lever arm as follows: C/A, C/B and C/mean depth. The data were compared with those obtained in 84 cadaver feet with no previous injury of the Lisfranc joint complex. Statistical analysis used Student’s two-sample t-test at the 5% error level and forward stepwise logistic regression. The mean medial depth of the mortise was found to be significantly less in patients with Lisfranc injuries than in the control group. Stepwise logistic regression identified only this depth as a significant risk factor for Lisfranc injuries. The odds of being in the injury group is 0.52 (approximately half) that of being a control if the medial depth of the mortise is increased by 1 mm, after adjusting for the other variables in the model. Our findings show that the mortise in patients with injuries to the Lisfranc joint is shallower than in the control group and the shallower it is the greater is the risk of injury


The Bone & Joint Journal
Vol. 101-B, Issue 5 | Pages 596 - 602
1 May 2019
El-Hawary A Kandil YR Ahmed M Elgeidi A El-Mowafi H

Aims

We hypothesized that there is no difference in the clinical and radiological outcomes using local bone graft versus iliac graft for subtalar distraction arthrodesis in patients with calcaneal malunion. In addition, using local bone graft negates the donor site morbidity.

Patients and Methods

We prospectively studied 28 calcaneal malunion patients (the study group) who were managed by subtalar distraction arthrodesis using local calcaneal bone graft. The study group included 16 male and 12 female patients. The median age was 37.5 years (interquartile range (IQR) 29 to 43). The outcome of the study group was compared with a control group of ten patients previously managed by subtalar distraction arthrodesis using iliac bone graft. The control group included six male and four female patients. The median age was 41.5 years (IQR 36 to 44).


The Bone & Joint Journal
Vol. 100-B, Issue 10 | Pages 1359 - 1363
1 Oct 2018
Chiu Y Chung T Wu C Tsai K Jou I Tu Y Ma C

Aims

This study reports the outcomes of a technique of soft-tissue coverage and Chopart amputation for severe crush injuries of the forefoot.

Patients and Methods

Between January 2012 to December 2016, 12 patients (nine male; three female, mean age 38.58 years; 26 to 55) with severe foot crush injury underwent treatment in our institute. All patients were followed-up for at least one year. Their medical records, imaging, visual analogue scale score, walking ability, complications, and functional outcomes one year postoperatively based on the American Orthopedic Foot and Ankle Society (AOFAS) and 36-Item Short-Form Health Survey (SF-36) scores were reviewed.


The Bone & Joint Journal
Vol. 98-B, Issue 6 | Pages 806 - 811
1 Jun 2016
Akimau PI Cawthron KL Dakin WM Chadwick C Blundell CM Davies MB

Aims

The purpose of this study was to compare symptomatic treatment of a fracture of the base of the fifth metatarsal with immobilisation in a cast.

Our null hypothesis was that immobilisation gave better patient reported outcome measures (PROMs). The alternative hypothesis was that symptomatic treatment was not inferior.

Patients and Methods

A total of 60 patients were randomised to receive four weeks of treatment, 36 in a double elasticated bandage (symptomatic treatment group) and 24 in a below-knee walking cast (immobilisation group). The primary outcome measure used was the validated Visual Analogue Scale Foot and Ankle (VAS-FA) Score. Data were analysed by a clinician, blinded to the form of treatment, at presentation and at four weeks, three months and six months after injury. Loss to follow-up was 43% at six months. Multiple imputations missing data analysis was performed.


The Bone & Joint Journal
Vol. 98-B, Issue 5 | Pages 634 - 640
1 May 2016
Pedowitz DI Kane JM Smith GM Saffel HL Comer C Raikin SM

Aims

Few reports compare the contribution of the talonavicular articulation to overall range of movement in the sagittal plane after total ankle arthroplasty (TAA) and tibiotalar arthrodesis. The purpose of this study was to assess changes in ROM and functional outcomes following tibiotalar arthrodesis and TAA.

Patients and Methods

Patients who underwent isolated tibiotalar arthrodesis or TAA with greater than two-year follow-up were enrolled in the study. Overall arc of movement and talonavicular movement in the sagittal plane were assessed with weight-bearing lateral maximum dorsiflexion and plantarflexion radiographs. All patients completed Short Form-12 version 2.0 questionnaires, visual analogue scale for pain (VAS) scores, and the Foot and Ankle Ability Measure (FAAM).


The Bone & Joint Journal
Vol. 97-B, Issue 5 | Pages 662 - 667
1 May 2015
Mani SB Do H Vulcano E Hogan MV Lyman S Deland JT Ellis SJ

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

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

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

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