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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.


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 949 - 956
1 Sep 2024
Matthews PA Scammell BE Coughlin TA Nightingale J Ollivere BJ

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.


Aims

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.

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.


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)).


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. 102-B, Issue 2 | Pages 212 - 219
1 Feb 2020
Ræder BW Figved W Madsen JE Frihagen F Jacobsen SB Andersen MR

Aims

In a randomized controlled trial with two-year follow-up, patients treated with suture button (SB) for acute syndesmotic injury had better outcomes than patients treated with syndesmotic screw (SS). The aim of this study was to compare clinical and radiological outcomes for these treatment groups after five years.

Methods

A total of 97 patients with acute syndesmotic injury were randomized to SS or SB. The five-year follow-up rate was 81 patients (84%). The primary outcome was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Scale. Secondary outcome measures included Olerud-Molander Ankle (OMA) score, visual analogue scale (VAS), EuroQol five-dimension questionnaire (EQ-5D), range of movement, complications, reoperations, and radiological results. CT scans of both ankles were obtained after surgery, and after one, two, and five years.


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1496 - 1501
1 Nov 2017
Bali N Aktselis I Ramasamy A Mitchell S Fenton P

Aims

There has been an evolution recently in the management of unstable fractures of the ankle with a trend towards direct fixation of a posterior malleolar fragment. Within these fractures, Haraguchi type 2 fractures extend medially and often cannot be fixed using a standard posterolateral approach. Our aim was to describe the posteromedial approach to address these fractures and to assess its efficacy and safety.

Patients and Methods

We performed a review of 15 patients with a Haraguchi type 2 posterior malleolar fracture which was fixed using a posteromedial approach. Five patients underwent initial temporary spanning external fixation. The outcome was assessed at a median follow-up of 29 months (interquartile range (IQR) 17 to 36) using the Olerud and Molander score and radiographs were assessed for the quality of the reduction.


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1502 - 1507
1 Nov 2017
Hong CC Tan JH Lim SH Nather A

Aims

Limb salvage for diabetic foot infections often require multiple procedures. Some patients will eventually end up with below knee amputation (BKA) when all limb salvage attempts fail. We seek to study the patients’ ability to return to normal life, functional status, prosthesis usage and perspectives on multiple limb salvage procedures that culminated in BKA to review if they would undertake a similar path if their situation was repeated.

Patients and Methods

A total of 41 patients who underwent BKA between July 2011 and June 2013 were reviewed. They were divided into primary and creeping (prior multiple salvage procedures) amputations. The Barthel’s Index (BI) and the Reintegration to Normal Living Index (RNLI) were used. A questionnaire was used to identify whether the patient would undergo the same multiple attempts at limb salvage again if faced with the same problem.


The Bone & Joint Journal
Vol. 97-B, Issue 4 | Pages 510 - 515
1 Apr 2015
Hutchison AM Topliss C Beard D Evans RM Williams P

The Swansea Morriston Achilles Rupture Treatment (SMART) programme was introduced in 2008. This paper summarises the outcome of this programme. Patients with a rupture of the Achilles tendon treated in our unit follow a comprehensive management protocol that includes a dedicated Achilles clinic, ultrasound examination, the use of functional orthoses, early weight-bearing, an accelerated exercise regime and guidelines for return to work and sport. The choice of conservative or surgical treatment was based on ultrasound findings.

The rate of re-rupture, the outcome using the Achilles Tendon Total Rupture Score (ATRS) and the Achilles Tendon Repair Score, (AS), and the complications were recorded. An elementary cost analysis was also performed.

Between 2008 and 2014 a total of 273 patients presented with an acute rupture 211 of whom were managed conservatively and 62 had surgical repair. There were three re-ruptures (1.1%). There were 215 men and 58 women with a mean age of 46.5 years (20 to 86). Functional outcome was satisfactory. Mean ATRS and AS at four months was 53.0 (sd 14), 64.9 (sd 15) (n = 135), six months 67.8 (sd 16), 73.8 (sd 15) (n = 103) and nine months (72.4; sd 14) 72.3 (sd 13) (n = 43). The programme realised estimated cost savings exceeding £91 000 per annum.

The SMART programme resulted in a low rate of re-rupture, a satisfactory outcome, a reduced rate of surgical intervention and a reduction in healthcare costs.

Cite this article: Bone Joint J 2015; 97-B:510–15.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 8 | Pages 1071 - 1078
1 Aug 2011
Keating JF Will EM

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

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

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


The Bone & Joint Journal
Vol. 97-B, Issue 3 | Pages 353 - 357
1 Mar 2015
Maffulli N Oliva F Costa V Del Buono A

We hypothesised that a minimally invasive peroneus brevis tendon transfer would be effective for the management of a chronic rupture of the Achilles tendon. In 17 patients (three women, 14 men) who underwent minimally invasive transfer and tenodesis of the peroneus brevis to the calcaneum, at a mean follow-up of 4.6 years (2 to 7) the modified Achilles tendon total rupture score (ATRS) was recorded and the maximum circumference of the calf of the operated and contralateral limbs was measured. The strength of isometric plantar flexion of the gastrocsoleus complex and of eversion of the ankle were measured bilaterally. Functional outcomes were classified according to the four-point Boyden scale.

At the latest review, the mean maximum circumference of the calf of the operated limb was not significantly different from the pre-operative mean value, (41.4 cm, 32 to 50 vs 40.6 cm, 33 to 46; p = 0.45), and not significantly less than that of the contralateral limb (43.1 cm, 35 to 52; p = 0.16). The mean peak torque (244.6 N, 125 to 367) and the strength of eversion of the operated ankle (149.1 N, 65 to 240) were significantly lower (p < 0.01) than those of the contralateral limb (mean peak torque 289, 145 to 419; strength of eversion: 175.2, 71 to 280). The mean ATRS significantly improved from 58 pre-operatively (35 to 68) to 91 (75 to 97; 95% confidence interval 85.3 to 93.2) at the time of final review. Of 13 patients who practised sport at the time of injury, ten still undertook recreational activities.

This procedure may be safely performed, is minimally invasive, and allows most patients to return to pre-injury sport and daily activities.

Cite this article: Bone Joint J 2015;97-B:353–7.


The Bone & Joint Journal
Vol. 95-B, Issue 4 | Pages 504 - 509
1 Apr 2013
Hutchison AM Pallister I Evans RM Bodger O Topliss CJ Williams P Beard DJ

We conducted a randomised controlled trial to determine whether active intense pulsed light (IPL) is an effective treatment for patients with chronic mid-body Achilles tendinopathy. A total of 47 patients were randomly assigned to three weekly therapeutic or placebo IPL treatments. The primary outcome measure was the Victorian Institute of Sport Assessment – Achilles (VISA-A) score. Secondary outcomes were a visual analogue scale for pain (VAS) and the Lower Extremity Functional Scale (LEFS). Outcomes were recorded at baseline, six weeks and 12 weeks following treatment. Ultrasound assessment of the thickness of the tendon and neovascularisation were also recorded before and after treatment.

There was no significant difference between the groups for any of the outcome scores or ultrasound measurements by 12 weeks, showing no measurable benefit from treatment with IPL in patients with Achilles tendinopathy.

Cite this article: Bone Joint J 2013;95-B:504–9.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 6 | Pages 793 - 798
1 Jun 2012
Bianchi A Martinelli N Sartorelli E Malerba F

The Bologna–Oxford (BOX) total ankle replacement (TAR) was developed with the aim of achieving satisfactory pain-free movement of the ankle. To date, only one single multicentre study has reported its clinical results. The aim of this study was to conduct an independent review of its mid-term results.

We retrospectively reviewed a total of 60 prospectively followed patients in whom 62 BOX TARs had been implanted between 2004 and 2008. We used the American Orthopedic Foot and Ankle Society (AOFAS) score to assess the clinical results. Standardised radiographs taken at the time of final follow-up were analysed by two observers. The overall survival was 91.9% at a mean follow-up of 42.5 months (24 to 71). The mean AOFAS score had improved from 35.1 points (sd 16.6; 4 to 73) pre-operatively to 78.0 (sd 10.7; 57 to 100) at final follow-up (p < 0.01). Tibial radiolucencies < 2 mm in width were seen around 16 TARs. Talar radiolucencies < 2 mm were seen around four TARs. A total of 47 patients (78.3%) were very satisfied or satisfied with the outcome. Five patients required revision for functional limitation or continuing pain.


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 9 | Pages 1262 - 1266
1 Sep 2010
Carda S Molteni F Bertoni M Zerbinati P Invernizzi M Cisari C

This study assessed if transfer of the extensor hallucis longus is a valid alternative treatment to split transfer of the tibialis anterior tendon in adult hemiplegic patients without overactivity of the tibialis anterior.

One group of 15 patients had overactivity of tibialis anterior in the swing phase, and underwent the split transfer. A further group of 14 patients had no overactivity of tibialis anterior, and underwent transfer of extensor hallucis longus. All patients had lengthening of the tendo Achillis and tenotomies of the toe flexors. All were evaluated clinically and by three-dimensional gait analysis pre- and at one year after surgery. At this time both groups showed significant reduction of disability in walking. Gait speed, stride length and paretic propulsion had improved significantly in both groups. Dorsiflexion in the swing phase, the step length of the healthy limb and the step width improved in both groups, but only reached statistical significance in the patients with transfer of the extensor hallucis longus. There were no differences between the groups at one year after operation.

When combined with lengthening of the tendo Achillis, transfer of the extensor hallucis longus can be a valid alternative to split transfer of the tibialis anterior tendon to correct equinovarus foot deformity in patients without overactivity of tibialis anterior.


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 1 | Pages 57 - 60
1 Jan 2008
Koureas G Rampal V Mascard E Seringe R Wicart P

Rocker bottom deformity may occur during the conservative treatment of idiopathic congenital clubfoot. Between 1975 and 1996, we treated 715 patients (1120 clubfeet) conservatively. A total of 23 patients (36 feet; 3.2%) developed a rocker bottom deformity. It is these patients that we have studied. The pathoanatomy of the rocker bottom deformity is characterised by a plantar convexity appearing between three and six months of age with the hindfoot equinus position remaining constant. The convexity initially involves the medial column, radiologically identified by the talo-first metatarsal angle and secondly by the lateral column, revealed radiologically as the calcaneo-fifth metatarsal angle. The apex of the deformity is usually at the midtrasal with a dorsal calcaneocuboid subluxation. Ideal management of clubfoot deformity should avoid this complication, with adequate manipulation and splinting and early Achilles’ percutaneous tenotomy if plantar convexity occurs.

Adequate soft-tissue release provides satisfactory correction for rocker bottom deformity. However, this deformity requires more extensive and complex procedures than the standard surgical treatment of clubfoot. The need for lateral radiographs to ensure that the rocker bottom deformity is recognised early, is demonstrated.


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.