Dataset Information

Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study.

ABSTRACT:

Introduction

Ankle fractures result in significant morbidity in adults, with prognosis worsening with increasing age. Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group. The Ankle Fracture Treatment: Enhancing Rehabilitation study is a pilot randomised controlled trial to assess feasibility of a later definitive trial comparing best-practice advice with progressive functional exercise for adults aged 50 years and over after ankle fracture.The main objectives are to assess: (i) patient engagement with the trial, measured by the participation rate of those eligible; (ii) establish whether the interventions are acceptable to participants and therapists, assessed by intervention adherence levels, participant interviews and a therapist focus group; (iii) participant retention in the trial, measured by the proportion of participants providing outcome data at 6 months; (iv) acceptability of measuring outcomes at 3 and 6?month follow-up.

Methods and analysis

A multicentre pilot randomised controlled trial with an embedded qualitative study. At least 48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK. Participants will be allocated 1:1 via a central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy). An embedded qualitative study will include one-to-one interviews with up to 20 participants and a therapist focus group.

Ethics and dissemination

Hampshire B Research Ethics Committee (18/SC/0281) gave approval on 2^nd July 2018.

Trial registration number

ISRCTN16612336.

SUBMITTER: Keene DJ

PROVIDER: S-EPMC6830709 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study.

Keene David J DJ Costa Matthew L ML Tutton Elizabeth E Hopewell Sally S Barber Vicki S VS Dutton Susan J SJ Redmond Anthony C AC Willett Keith K Lamb Sarah E SE

BMJ open 20191102 11

<h4>Introduction</h4>Ankle fractures result in significant morbidity in adults, with prognosis worsening with increasing age. Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group. The Ankle Fracture Treatment: Enhancing Rehabilitation study is a pilot randomised controlled trial to assess feasibility of a later definitive trial comp ...[more]

PMID: 31678945

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Project description:ObjectivesTo explore patient and staff experience of best-practice rehabilitation advice (one session of face-to-face self-management advice with up to two additional optional sessions) compared with progressive functional exercise (up to six sessions of face-to-face physiotherapy) after ankle fracture.DesignThe study drew on phenomenology using interviews and a focus group.SettingParticipants were from three NHS Trusts in England, UK.ParticipantsA purposive sample of 20 patients with ankle (malleolar) fractures from the Ankle Fracture Treatment: Enhancing Rehabilitation-pilot trial (now completed) were interviewed (median 50 min) from May 2019 to January 2020. They were 6 months post injury, over 50 years of age, (median 66, 12 females) and had received surgical or non-surgical treatment (seven internal fixation surgery, seven close contact casting, six walking boot). A focus group of five physiotherapists who had provided the study interventions (2.5 hours) was undertaken.ResultsThe findings show the acceptability of both interventions through the themes, 'being helped' (for patients) and 'developing expertise' (for staff) with subthemes of choosing and progressing. Progressive exercise added value with a perceived increase in strength, motion, ability to undertake activities and continued use of the workbook. Both staff and patients valued physiotherapy expertise demonstrated through interpersonal skills, advice, individualised exercise plans and active monitoring of progression. Best practice advice was particularly helpful in the early stages of recovery and with the use of mobility aids.ConclusionBoth interventions were acceptable but progressive exercise was highly valued by patients. Developing expertise through experiential learning enabled staff to facilitate progression. Adjustments to the workbook and the addition of exercises for continued recovery in the best practice advice would enhance a future study. Research during treatment provision may provide further insights into the challenges of facilitating progression of exercise.Trial registrationISRCTN16612336; AFTER-pilot trial).

Project description:BackgroundConventionally, transsyndesmotic fibula fractures with concomitant signs of deltoid ligament injury have been considered unstable and thus treated operatively. Recent studies have indicated that partial deltoid ligament rupture is common and may allow for nonoperative treatment of stress-unstable ankles if normal tibiotalar alignment is obtained in the weightbearing position. Biomechanical support for this principle is scarce. The purpose of this study was to evaluate the biomechanical effects of gradually increasing deltoid ligament injury in transsyndesmotic fibula fractures.MethodsFifteen cadaveric ankle specimens were tested using an industrial robot. All specimens were tested in 4 states: native, SER2, SER4a, and SER4b models. Ankle stability was measured in lateral translation, valgus, and internal and external rotation stress in 3 talocrural joint positions: 20 degrees plantarflexion, neutral, and 10 degrees dorsiflexion. Talar shift and talar valgus tilt in the talocrural joint was measured using fluoroscopy.ResultsIn most tests, SER2 and SER4a models resulted in a small instability increase compared to native joints and thus were deemed stable according to our predefined margins. However, SER4a models were unstable when tested in the plantarflexed position and for external rotation in all positions. In contrast, SER4b models had large-magnitude instability in all directions and all tested positions and were thus deemed unstable.ConclusionThis study demonstrated substantial increases in instability between the SER4a and SER4b states. This controlled cadaveric simulation suggests a significant ankle-stabilizing role of the deep posterior deltoid after oblique transsyndesmotic fibular fracture and transection of the superficial and anterior deep deltoid ligaments.Clinical relevanceThe study provides new insights into how the heterogenicity of deltoid ligament injuries can affect the natural stability of the ankle after Weber B fractures. These findings may be useful in developing more targeted and better treatment strategies.

Project description:BackgroundPatients with end-stage ankle osteoarthritis suffer from reduced mobility and quality of life and the main surgical treatments are total ankle replacement (TAR) and ankle fusion (AF).ObjectivesOur aim was to calculate the mean incremental cost per quality-adjusted life-year (QALY) of TAR compared with AF in patients with end-stage ankle osteoarthritis, over 52 weeks and over the patients' lifetime.MethodWe conducted a cost-utility analysis of 282 participants from 17 UK centres recruited to a randomised controlled trial (TARVA). QALYs were calculated using index values from EQ-5D-5L. Resource use information was collected from case report forms and self-completed questionnaires. Primary analysis was within-trial analysis from the National Health Service (NHS) and Personal Social Services (PSS) perspective, while secondary analyses were within-trial analysis from wider perspective and long-term economic modelling. Adjustments were made for baseline resource use and index values.ResultsTotal cost at 52 weeks was higher in the TAR group compared with the AF group, from the NHS and PSS perspective (mean adjusted difference £2539, 95% confidence interval [CI] £1142, £3897). The difference became very small from the wider perspective (£155, 95% CI - £1947, £2331). There was no significant difference between TAR and AF in terms of QALYs (mean adjusted difference 0.02, 95% CI - 0.015, 0.05) at 52 weeks post-operation. The incremental cost-effectiveness ratio (ICER) was £131,999 per QALY gained 52 weeks post-operation. Long-term economic modelling resulted in an ICER of £4200 per QALY gained, and there is a 69% probability of TAR being cost effective at a cost-effectiveness threshold of £20,000 per QALY gained.ConclusionTAR does not appear to be cost effective over AF 52 weeks post-operation. A decision model suggests that TAR can be cost effective over the patients' lifetime but there is a need for longer-term prospectively collected data. Clinical trial registration ISRCTN60672307 and ClinicalTrials.gov NCT02128555.

Project description:This study aimed to investigate the epidemiology of low-energy lower-extremity fracture in Chinese men and women aged 50 years and above. This study was a part of Chinese National Fracture Survey (CNFS), which used the stratified multistage cluster random sampling method to recruit subjects between January and May 2015. A total of 512187 individuals participated in the CNFS and of them there were 154099 men and women aged 50 years and above included in this study for data analysis. Low-energy fracture was defined as a fracture caused by slip, trip or fall from standing height. Univariate analyses and gender-based multivariate logistic regression models were constructed to identify the independent risk factors. A total of 215 patients had sustained low-energy lower extremity fractures in 2014, indicating the overall incidence was 139.5 (120.9 to 158.2) per 100000 persons, with 127.8 (102.5 to 153.1) and 151.1 (123.8 to 178.5) per 100000 person-year in men and women. Over 80% of fractures occurred at home and on the common road. In men, alcohol consumption (OR, 2.00; 95%CI, 1.29 to 3.08), sleep duration<7h/d (OR, 2.60; 95%CI, 1.68 to 4.03) and history of past fracture (OR, 2.57; 95%CI, 1.33 to 4.95) were identified as significant risk factors associated with low-energy fractures. In women, advanced age (80+ years) (OR, 3.22; 95%CI, 1.80 to 5.75), alcohol consumption(OR, 1.72; 95%CI, 1.00 to 2.98), sleep duration <7h/d (OR, 2.11; 95%CI, 1.40 to 3.18), and history of past fracture (OR, 3.46; 95%CI, 1.97 to 6.09) were identified as significant risk factors and living in western region (OR, 0.60; 95%CI, 0.38 to 0.94) and current weight of 50 to 59.9 kg (OR, 0.17; 95%CI, 0.04 to 0.73) were identified as protective factors for fractures. Accordingly, awareness on the importance of sleep and alcohol consumption on fragility fracture should be improved, and health policies that focus on decreasing alcohol consumption and encouraging individuals to improve their sleep quality and duration should be considered. Maintaining a healthy bodyweight for women should be specifically emphasized to prevent low-energy fractures.

Project description:BackgroundAnkle fractures are one of the most common orthopedic injuries, and although most patients have a satisfactory outcome following operative fixation, there are patients that have persistent pain despite anatomic reduction. Intra-articular injuries have been suggested as one potential cause of these suboptimal outcomes. Our study assesses the clinical impact of performing an ankle arthroscopy during ankle fracture open reduction and internal fixation (ORIF).MethodsThis was a retrospective chart review of all patients who underwent operative fixation of a bimalleolar or trimalleolar ankle fracture at our institution from 2014 through 2018. We extracted all demographic data, fracture pattern, operative procedures performed, tourniquet times, arthroscopic findings and any arthroscopic interventions. We then conducted a phone and e-mail survey. Our study included 213 total patients (142 traditional ORIF, 71 ORIF plus arthroscopy) with an average age of 40 years. The average follow-up was 32.4 months with a survey follow-up rate of 50.7% (110/213).ResultsThe average tourniquet time for the arthroscopy cohort was 10 minutes longer (89 minutes vs 79 minutes). During the arthroscopy, there was a 28% (20/71) rate of full-thickness osteochondral lesions, 33% (24/71) rate of loose bodies, and a 49% (35/71) rate of partial-thickness cartilage injury. The mean Patient Reported Outcome Information System (PROMIS) physical function score among Weber B fibula fractures was 45.8 and 42.3 in the arthroscopy and nonarthroscopy groups, respectively (P = .012). In addition, the patient satisfaction rate in Weber B fibula fractures was higher in those patients who underwent arthroscopy compared with ORIF alone (93% vs 75%, P = .05). Patients who had a tibiotalar joint dislocation at the time of the ankle fracture had a significantly higher PROMIS physical function score (46.6 vs 40.2, P = .005) when their surgery included arthroscopy.ConclusionAnkle arthroscopy at the time of ORIF led to statistically significant improvements in patient-reported outcomes for Weber B fibula fractures and ankle dislocations. There was no increase in complication rates and the arthroscopy took 10 minutes longer on average.Level of evidenceLevel III, retrospective cohort study.

Project description:ObjectiveTo predict functional outcomes 6 months after ankle fracture in people aged ≥60 years using post-treatment and 6-week follow-up data to inform anticipated recovery, and identify people who may benefit from additional monitoring or rehabilitation.DesignPrognostic model development and internal validation.Setting24 National Health Service hospitals, UK.MethodsParticipants were the Ankle Injury Management clinical trial cohort (n=618) (ISRCTN04180738), aged 60-96 years, 459/618 (74%) female, treated surgically or conservatively for unstable ankle fracture. Predictors were injury and sociodemographic variables collected at baseline (acute hospital setting) and 6-week follow-up (clinic). Outcome measures were 6-month postinjury (primary) self-reported ankle function, using the Olerud and Molander Ankle Score (OMAS), and (secondary) Timed Up and Go (TUG) test by blinded assessor. Missing data were managed with single imputation. Multivariable linear regression models were built to predict OMAS or TUG, using baseline variables or baseline and 6-week follow-up variables. Models were internally validated using bootstrapping.ResultsThe OMAS baseline data model included: alcohol per week (units), postinjury EQ-5D-3L visual analogue scale (VAS), sex, preinjury walking distance and walking aid use, smoking status and perceived health status. The baseline/6-week data model included the same baseline variables, minus EQ-5D-3L VAS, plus five 6-week predictors: radiological malalignment, injured ankle dorsiflexion and plantarflexion range of motion, and 6-week OMAS and EQ-5D-3L. The models explained approximately 23% and 26% of the outcome variation, respectively. Similar baseline and baseline/6 week data models to predict TUG explained around 30% and 32% of the outcome variation, respectively.ConclusionsPredictive accuracy of the prognostic models using commonly recorded clinical data to predict self-reported or objectively measured ankle function was relatively low and therefore unlikely to be beneficial for clinical practice and counselling of patients. Other potential predictors (eg, psychological factors such as catastrophising and fear avoidance) should be investigated to improve predictive accuracy.Trial registration numberISRCTN04180738; Post-results.

Project description:UnlabelledPatient characteristics contributing to imminent risk for fracture, defined as risk of near-term fracture within the next 12 to 24 months, have not been well defined. In patients without recent fracture, we identified factors predicting imminent risk for vertebral/nonvertebral fracture, including falls, age, comorbidities, and other potential fall risk factors.PurposeSeveral factors contribute to long-term fracture risk in patients with osteoporosis, including age, bone mineral density, and fracture history. Some patients may be at imminent risk for fracture, defined here as a risk of near-term fracture within 12-24 months. Many patient characteristics contributing to imminent risk for fracture have not been well defined. This case-control study used US commercial and Medicare supplemental insured data for women and men without recent fracture to identify factors associated with imminent risk for fracture.MethodsPatients included were aged ≥50 with osteoporosis, had a vertebral or nonvertebral fracture claim (index date; fracture group) or no fracture claim (control group) from January 1, 2006, to September 30, 2012, continuously enrolled and without fracture in the 24 months before index. Potential risk factors during the period before fracture were assessed.ResultsUsing data from 12 months before fracture, factors significantly associated with imminent risk for fracture were previous falls, older age, poorer health status, specific comorbidities (psychosis, Alzheimer's disease, central nervous system disease), and other fall risk factors (wheelchair use, psychoactive medication use, mobility impairment). Similar findings were observed with data from 24 months before fracture.ConclusionsIn patients with osteoporosis and no recent fracture, falls, older age, poorer health status, comorbidities, and other potential fall risk factors were predictive of imminent risk for fracture. Identification of factors associated with imminent risk for vertebral/nonvertebral fracture may help identify and risk stratify those patients most in need of immediate and appropriate treatment to decrease fracture risk.

Dataset Information

Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study.

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