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Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial.

ABSTRACT: Following surgical fixation of ankle fractures, the traditional management has included immobilisation for 6 weeks in a below-knee cast. However, this can lead to disuse atrophy of the affected leg and joint stiffness. While early rehabilitation from 2 weeks post surgery is viewed as safe, controversy remains regarding its benefits. We will compare the effectiveness of early motion and directed exercise (EMADE) ankle rehabilitation, against usual care, i.e. 6 weeks' immobilisation in a below-knee cast.We have designed a pragmatic randomised controlled trial (p-RCT) to compare the EMADE intervention against usual care. We will recruit 144 independently living adult participants, absent of tissue-healing comorbidities, who have undergone surgical stabilisation of isolated Weber B ankle fractures. The EMADE intervention consists of a non-weight-bearing progressive home exercise programme, complemented with manual therapy and education. Usual care consists of immobilisation in a non-weight-bearing below-knee cast. The intervention period is between week 2 and week 6 post surgery. The primary outcome is the Olerud and Molander Ankle Score (OMAS) patient-reported outcome measure (PROM) at 12 weeks post surgery. Secondary PROMs include the EQ-5D-5 L questionnaire, return to work and return to driving, with objective outcomes including ankle range of motion. Analysis will be on an intention-to-treat basis. An economic evaluation will be included.The EMADE intervention is a package of care designed to address the detrimental effects of disuse atrophy and joint stiffness. An advantage of the OMAS is the potential of meta-analysis with other designs. Within the economic evaluation, the cost-utility analysis, may be used by commissioners, while the use of patient-relevant outcomes, such as return to work and driving, will ensure that the study remains pertinent to patients and their families. As it is being conducted in the clinical environment, this p-RCT has high external validity. Accordingly, if significant clinical benefits and cost-effectiveness are demonstrated, EMADE should become a worthwhile treatment option. A larger-scale, multicentre trial may be required to influence national guidelines.ISRCTN, ID: ISRCTN11212729 . Registered retrospectively on 20 March 2017.

SUBMITTER: Matthews PA

PROVIDER: S-EPMC5984379 | biostudies-other | 2018 May

REPOSITORIES: biostudies-other

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Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial.

Matthews Paul A PA Scammell Brigitte E BE Ali Arfan A Coughlin Timothy T Nightingale Jessica J Khan Tanvir T Ollivere Ben J BJ

Trials 20180531 1

<h4>Background</h4>Following surgical fixation of ankle fractures, the traditional management has included immobilisation for 6 weeks in a below-knee cast. However, this can lead to disuse atrophy of the affected leg and joint stiffness. While early rehabilitation from 2 weeks post surgery is viewed as safe, controversy remains regarding its benefits. We will compare the effectiveness of early motion and directed exercise (EMADE) ankle rehabilitation, against usual care, i.e. 6 weeks' immobilisa ...[more]

PMID: 29855386

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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:BackgroundPostoperative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. There is an evolving understanding that extended periods of immobilisation and weight-bearing limitation may lead to poorer clinical outcomes. Traditional non-weight-bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates.MethodsA pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 h versus non-weight-bearing (NWB) and immobilisation in a cast for 6 weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury) is proposed. All patients presenting to three trauma units will be included. The exclusion criteria will be skeletal immaturity and tibial plafond fractures. The three institutional review boards have granted ethical approval. The primary outcome measure will be the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. The trial will be reported in accordance with the CONSORT statement for reporting a pragmatic trial, and this protocol will follow the SPIRIT guidance.DiscussionTraditional management of operatively treated ankle fractures includes an extended period of non-weight-bearing. There is emerging evidence that earlier weight-bearing may have equivocal outcomes and favourable patient satisfaction but higher wound-related complications. These studies often preclude more complicated fracture patterns or patient-related factors. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. This pragmatic randomised-controlled multicentre trial will investigate immediate weight-bearing following ORIF of all ankle fracture patterns in the usual care condition. It is hoped that these results will contribute to the modern management of ankle fractures.Trial registrationISRCTN Registry ISRCTN76410775 . Retrospectively registered on 30 June 2019.

Project description:IntroductionAnkle 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 analysisA 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 disseminationHampshire B Research Ethics Committee (18/SC/0281) gave approval on 2nd July 2018.Trial registration numberISRCTN16612336.

Project description:BACKGROUND:Tai Chi (TC) is a mind-body exercise that shows potential as an effective and safe intervention for preventing fall-related fractures in the elderly. Few randomized trials have simultaneously evaluated TC's potential to reduce bone loss and improve fall-predictive balance parameters in osteopenic women. METHODS:In a pragmatic randomized trial, 86 post-menopausal osteopenic women, aged 45-70, were recruited from community clinics. Women were assigned to either nine months of TC training plus usual care (UC) vs. UC alone. Primary outcomes were changes between baseline and nine months of bone mineral density (BMD) of the proximal femur and lumbar spine (dual-energy X-ray absorptiometry) and serum markers of bone resorption and formation. Secondary outcomes included quality of life. In a subsample (n = 16), quiet standing fall-predictive sway parameters and clinical balance tests were also assessed. Both intent-to-treat and per-protocol analyses were employed. RESULTS:For BMD, no intent-to-treat analyses were statistically significant; however, per protocol analyses (i.e., only including TC participants who completed ? 75% training requirements) of femoral neck BMD changes were significantly different between TC and UC (+0.04 vs. -0.98%; P = 0.05). Changes in bone formation markers and physical domains of quality of life were also more favorable in per protocol TC vs. UC (P = 0.05). Changes in sway parameters were significantly improved by TC vs. UC (average sway velocity, P = 0.027; anterior-posterior sway range, P = 0.014). Clinical measures of balance and function showed non-significant trends in favor of TC. CONCLUSIONS:TC training offered through existing community-based programs is a safe, feasible, and promising intervention for reducing multiple fracture risks. Our results affirm the value of a more definitive, longer-term trial of TC for osteopenic women, adequately powered to detect clinically relevant effects of TC on attenuation of BMD loss and reduction of fall risk in this population. TRIAL REGISTRATION:ClinicalTrials.gov: NCT01039012.

Dataset Information

Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial.

Publications

Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial.

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