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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. 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.


Bone & Joint Open
Vol. 5, Issue 3 | Pages 227 - 235
18 Mar 2024
Su Y Wang Y Fang C Tu Y Chang C Kuan F Hsu K Shih C

Aims. 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. Methods. We conducted a comprehensive review of clinical trials comparing anteroposterior (A-P) screws, posteroanterior (P-A) screws, and plate fixation. Two investigators validated the data sourced from multiple databases (MEDLINE, EMBASE, and Web of Science). Following PRISMA guidelines, we carried out a network meta-analysis (NMA) using visual analogue scale and American Orthopaedic Foot and Ankle Score (AOFAS) as primary outcomes. Secondary outcomes included range of motion limitations, radiological outcomes, and complication rates. Results. The NMA encompassed 13 studies, consisting of four randomized trials and eight retrospective ones. According to the surface under the cumulative ranking curve-based ranking, the A-P screw was ranked highest for improvements in AOFAS and exhibited lowest in infection and peroneal nerve injury incidence. The P-A screws, on the other hand, excelled in terms of VAS score improvements. Conversely, posterior buttress plate fixation showed the least incidence of osteoarthritis grade progression, postoperative articular step-off ≥ 2 mm, nonunions, and loss of ankle dorsiflexion ≥ 5°, though it underperformed in most other clinical outcomes. Conclusion. The NMA suggests that open plating is more likely to provide better radiological outcomes, while screw fixation may have a greater potential for superior functional and pain results. Nevertheless, clinicians should still consider the fragment size and fracture pattern, weighing the advantages of rigid biomechanical fixation against the possibility of soft-tissue damage, to optimize treatment results. Cite this article: Bone Jt Open 2024;5(3):227–235


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 10 | Pages 841 - 849
27 Oct 2022
Knight R Keene DJ Dutton SJ Handley R Willett K

Aims

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.

Methods

Radiological (absolute radiological measurements aided by computer software) and clinical (clinical interpretation of radiographs) definitions of malunion were compared within the Ankle Injury Management (AIM) trial cohort, including people aged ≥ 60 years with an unstable ankle fracture. Linear regressions were used to explore the relationship between radiological malunion (RM) at six months and changes in function at three years. Function was assessed with the Olerud-Molander Ankle Score (OMAS), with a minimal clinically important difference set as six points, as per the AIM trial. Piecewise linear models were used to investigate new radiological thresholds which better explain symptom impact on ankle function.


The Bone & Joint Journal
Vol. 104-B, Issue 8 | Pages 938 - 945
1 Aug 2022
Park YH Kim W Choi JW Kim HJ

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).


Bone & Joint Open
Vol. 3, Issue 6 | Pages 502 - 509
20 Jun 2022
James HK Griffin J Pattison GTR

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.


Bone & Joint Research
Vol. 11, Issue 4 | Pages 189 - 199
13 Apr 2022
Yang Y Li Y Pan Q Bai S Wang H Pan X Ling K Li G

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.


The Bone & Joint Journal
Vol. 98-B, Issue 10 | Pages 1312 - 1319
1 Oct 2016
Spang C Alfredson H Docking SI Masci L Andersson G

In recent years, the plantaris tendon has been implicated in the development of chronic painful mid-portion Achilles tendinopathy. In some cases, a thickened plantaris tendon is closely associated with the Achilles tendon, and surgical excision of the plantaris tendon has been reported to be curative in patients who have not derived benefit following conservative treatment and surgical interventions. The aim of this review is to outline the basic aspects of, and the recent research findings, related to the plantaris tendon, covering anatomical and clinical studies including those dealing with histology, imaging and treatment. Cite this article: Bone Joint J 2016;98-B:1312–19


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. 96-B, Issue 6 | Pages 778 - 782
1 Jun 2014
Tinney A Khot A Eizenberg N Wolfe R Graham HK

Lengthening of the conjoined tendon of the gastrocnemius aponeurosis and soleus fascia is frequently used in the treatment of equinus deformities in children and adults. The Vulpius procedure as described in most orthopaedic texts is a division of the conjoined tendon in the shape of an inverted V. However, transverse division was also described by Vulpius and Stoffel, and has been reported in some clinical studies. We studied the anatomy and biomechanics of transverse division of the conjoined tendon in 12 human cadavers (24 legs). Transverse division of the conjoined tendon resulted in predictable, controlled lengthening of the gastrocsoleus muscle-tendon unit. The lengthening achieved was dependent both on the level of the cut in the conjoined tendon and division of the midline raphé. Division at a proximal level resulted in a mean lengthening of 15.2 mm (. sd . 2.0, (12 to 19), which increased to 17.1 mm (. sd . 1.8, (14 to 20) after division of the midline raphé. Division at a distal level resulted in a mean lengthening of 21.0 mm (. sd. 2.0, (18 to 25), which increased to 26.4 mm (. sd . 1.4, (24 to 29) after division of the raphé. These differences were significant (p < 0.001). Cite this article: Bone Joint J 2014; 96-B:778–82


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1349 - 1353
3 Oct 2020
Park CH Song K Kim JR Lee S

Aims

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.

Methods

Between September 2014 and July 2017, 25 patients with symptomatic osteochondritis of the talus and an osteochondral fragment, who were treated using bone peg fixation, were analyzed retrospectively. All were available for complete follow-up at a mean 22 of months (12 to 35). There were 15 males and ten females with a mean age of 19.6 years (11 to 34). The clinical results were evaluated using a visual analogue scale (VAS) and the American Orthopaedic Foot and Ankle Society (AOFAS) score preoperatively and at the final follow-up. The radiological results were evaluated using classification described by Hepple et al based on the MRI findings, the location of the lesion, the size of the osteochondral fragment, and the postoperative healing of the lesion.


Bone & Joint Research
Vol. 9, Issue 9 | Pages 613 - 622
1 Sep 2020
Perucca Orfei C Lovati AB Lugano G Viganò M Bottagisio M D’Arrigo D Sansone V Setti S de Girolamo L

Aims

In the context of tendon degenerative disorders, the need for innovative conservative treatments that can improve the intrinsic healing potential of tendon tissue is progressively increasing. In this study, the role of pulsed electromagnetic fields (PEMFs) in improving the tendon healing process was evaluated in a rat model of collagenase-induced Achilles tendinopathy.

Methods

A total of 68 Sprague Dawley rats received a single injection of type I collagenase in Achilles tendons to induce the tendinopathy and then were daily exposed to PEMFs (1.5 mT and 75 Hz) for up to 14 days - starting 1, 7, or 15 days after the injection - to identify the best treatment option with respect to the phase of the disease. Then, 7 and 14 days of PEMF exposure were compared to identify the most effective protocol.


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. 101-B, Issue 4 | Pages 447 - 453
1 Apr 2019
Sanders FRK Backes M Dingemans SA Hoogendoorn JM Schep NWL Vermeulen J Goslings JC Schepers T

Aims

The aim of this study was to evaluate the functional outcome in patients undergoing implant removal (IR) after fracture fixation below the level of the knee.

Patients and Methods

All adult patients (18 to 75 years) undergoing IR after fracture fixation below the level of the knee between November 2014 and September 2016 were included as part of the WIFI (Wound Infections Following Implant Removal Below the Knee) trial, performed in 17 teaching hospitals and two university hospitals in The Netherlands. In this multicentre prospective cohort, the primary outcome was the difference in functional status before and after IR, measured by the Lower Extremity Functional Scale (LEFS), with a minimal clinically important difference of nine points.


The Bone & Joint Journal
Vol. 100-B, Issue 8 | Pages 1054 - 1059
1 Aug 2018
Kelly C Harwood PJ Loughenbury PR Clancy JA Britten S

Aims

Anatomical atlases document classical safe corridors for the placement of transosseous fine wires through the calcaneum during circular frame external fixation. During this process, the posterior tibial neurovascular bundle (PTNVB) is placed at risk, though this has not been previously quantified. We describe a cadaveric study to investigate a safe technique for posterolateral to anteromedial fine wire insertion through the body of the calcaneum.

Materials and Methods

A total of 20 embalmed cadaveric lower limbs were divided into two groups. Wires were inserted using two possible insertion points and at varying angles. In Group A, wires were inserted one-third along a line between the point of the heel and the tip of the lateral malleolus while in Group B, wires were inserted halfway along this line. Standard dissection techniques identified the structures at risk and the distance of wires from neurovascular structures was measured. The results from 19 limbs were subject to analysis.


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 12 | Pages 1629 - 1636
1 Dec 2017
Sheth U Wasserstein D Jenkinson R Moineddin R Kreder H Jaglal S

Aims

To determine whether the findings from a landmark Canadian trial assessing the optimal management of acute rupture of the Achilles tendon influenced the practice patterns of orthopaedic surgeons in Ontario, Canada.

Materials and Methods

Health administrative databases were used to identify Ontario residents ≥ 18 years of age with an Achilles tendon rupture from April 2002 to March 2014. The rate of surgical repair (per 100 cases) was calculated for each calendar quarter. A time-series analysis was used to determine whether changes in the rate were chronologically related to the dissemination of results from a landmark trial published in February 2009. Non-linear spline regression was then used independently to identify critical time-points of change in the surgical repair rate to confirm the findings.


Bone & Joint Research
Vol. 6, Issue 7 | Pages 446 - 451
1 Jul 2017
Pękala PA Henry BM Pękala JR Piska K Tomaszewski KA

Objectives

Inflammation of the retrocalcaneal bursa (RB) is a common clinical problem, particularly in professional athletes. RB inflammation is often treated with corticosteroid injections however a number of reports suggest an increased risk of Achilles tendon (AT) rupture. The aim of this cadaveric study was to describe the anatomical connections of the RB and to investigate whether it is possible for fluid to move from the RB into AT tissue.

Methods

A total of 20 fresh-frozen AT specimens were used. In ten specimens, ink was injected into the RB. The remaining ten specimens were split into two groups to be injected with radiological contrast medium into the RB either with or without ultrasonography guidance (USG).