Evaluation of three patient reported outcome measures following operative fixation of closed ankle fractures

Garratt, Andrew; Naumann, Markus George; Sigurdsen, Ulf; Utvåg, Stein Erik; Stavem, Knut

doi:10.1186/s12891-018-2051-5

Cited by 33 publications

(72 citation statements)

References 26 publications

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“…The main outcome of OMAS is a well-established outcome score that has been validated for ankle fractures. 9 This study is also to our knowledge the first randomized controlled trial to compare the use of an ankle trainer versus conventional physiotherapy after surgically treated ankle fractures.…”

Section: Discussionmentioning

confidence: 98%

Compared to conventional physiotherapy, does the use of an ankle trainer device after Weber B ankle fracture operation improve outcome and shorten hospital stay? A randomized controlled trial

et al. 2020

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Objective: To compare the functional outcomes and length of hospital stay for patients treated with conventional physiotherapy compared to a new ankle trainer device after Weber B ankle fractures. Design: The patients were randomized, and then followed up at 3, 6, 12 and 52 weeks by a blinded physiotherapist. Setting: This study was done at a level 1 trauma centre. Subjects: One hundred and forty consecutive patients with Weber B ankle fractures that were operated on were screened for eligibility, of whom 113 were included in the study. Interventions: Conventional physiotherapy with stretching exercises, using a non-elastic band or using new ankle trainer. Main measures: Outcomes were evaluated with Olerud–Molander ankle score, Visual analogue scale for pain and ankle dorsiflexion at 3, 6, 12 and 52 weeks follow-up. Time of hospitalization and complications were registered. Results: Superior Olerud–Molander ankle scores were observed at three weeks follow-up in the ankle trainer group 40.9 (10.8), compared to the conventional group 35.3 (14.2) ( P = 0.021). At one-year follow-up, there was no difference between the groups ( P = 0.386). The ankle trainer group had a shorter hospital stay with a mean 2.6 days (0.98) compared to 3.2 days (1.47) in the conventional group ( P = 0.026). Conclusion: The patients who were treated with the new ankle trainer device recovered more rapidly, evaluated by the Olerud–Molander ankle score and had a shorter stay in hospital compared to the conventional physiotherapy group. No between group differences could be observed at long-term follow-up.

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Section: Discussionmentioning

confidence: 98%

Compared to conventional physiotherapy, does the use of an ankle trainer device after Weber B ankle fracture operation improve outcome and shorten hospital stay? A randomized controlled trial

et al. 2020

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“…This review highlights frequency of use of particular outcome measures over others in clinical trials of non-pharmacological interventions for ankle fracture, most notably the OMAS. Despite some evidence for the validity and reliability of the OMAS [25, 26], there is debate amongst clinicians and researchers regarding its suitability for use, particularly with regard to the lack of a formal development process and a systematic review highlighted concerns with this in particular [11]. The research group recommended the use of a newer PROM, developed in 2014 specifically for this injury, known as the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) [27].…”

Section: Discussionmentioning

confidence: 99%

Primary outcome measures used in interventional trials for ankle fractures: a systematic review

McKeown

Rabiu

Ellard

et al. 2019

BMC Musculoskelet Disord

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Background Ankle fractures cause considerable pain, loss of function and healthcare resource use. High quality randomised controlled trials are required to evaluate the optimal management protocols for ankle fracture. However, there is debate regarding the most appropriate outcome measure to use when assessing patients with ankle fractures. The aim of this systematic review is to identify and summarise primary outcome measure use in clinical trials of non-pharmacological interventions for adults with an ankle fracture. Methods We performed comprehensive searches of the Medline, Embase, CINAHL, AMED and Cochrane CENTRAL databases, as well as ISRCTN and ClinicalTrials.gov online clinical trial registries on 19/06/2019 with no date limits applied. The titles and abstracts were initially screened to identify randomised or quasi-randomised clinical trials of non-pharmacological interventions for ankle fracture in adults. Two authors independently screened the full text of any articles which could potentially be eligible. Descriptive statistics we used to summarise the outcome measures collected in these articles including an assessment of trends over time. Secondary analysis included a descriptive summary of the multi-item patient reported outcome measures used in this study type. Results The searches returned a total of 3380 records. Following application of the eligibility criteria, 121 records were eligible for inclusion in this review. The most frequently collected primary outcome measures in this type of publication was the Olerud Molander Ankle Score, followed by radiographic and range of movement assessments. There was a total of 28 different outcome measures collected and five different multi-item, patient reported outcome measures collected as the primary outcome measure. There was a sequential increase in the number of this type of study published per decade since the 1980’s. Conclusion This review demonstrates the wide range of measurement methods used to assess outcome in adults with an ankle fracture. Future research should focus on establishing the validity and reliability of the outcome measures used in this patient population. Formulation of a consensus based core outcome set for adults with an ankle fracture would be advantageous for ensuring homogeneity across studies in order to meta-analyse trial results. Electronic supplementary material The online version of this article (10.1186/s12891-019-2770-2) contains supplementary material, which is available to authorized users.

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“…A final score is calculated from 0 to 100, with 100 representing a better functional outcome. A recent study found that the OMAS had acceptable levels of internal consistency and test-retest validity, and correlated strongly with other lower limb injury outcome scoring systems and measures of general health, including the EQ-5D [29]. The primary null hypothesis is that there is no difference in outcome (primary outcome measure, OMAS) after 1 year between fixation of associated medial malleolus fractures and non-fixation in patients undergoing surgery for an unstable fracture of the ankle.…”

Section: Methodsmentioning

confidence: 99%

Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle

Carter

Oliver

Graham

et al. 2019

Trials

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Background There are limited data reporting the outcome of patients with non-operatively managed medial malleolus fractures compared to those treated surgically in the presence of fibular stabilisation for unstable fractures of the ankle. Conservative management could result in fewer complications, reduced surgical time and lower cost. The purpose of this study is to determine if any difference exists in patient reported and surgical outcomes 1 year after surgery between operative and non-operative treatment of medial malleolar fractures in combination with stabilisation of the lateral malleolus. Methods/design This is a single-centre, prospective, randomised controlled trial that aims to randomise 154 participants with an unstable ankle fracture to ‘non-fixation’ (n = 77) or ‘fixation’ (n = 77) of an associated well-reduced medial malleolus fracture following fibular stabilisation. The study will include patients ≥ 16 years of age with a closed bimalleolar or trimalleolar ankle fracture who are able to consent, complete questionnaires in the English language, and complete follow-up over a 1-year period. Randomisation will occur intra-operatively when the medial malleolus fracture is deemed ‘well-reduced’, with 2 mm or less of fluoroscopic displacement. The technique for fixation of both the medial and lateral malleoli is at the discretion of the operating surgeon. Patient-reported, observer-rated, and radiographic assessments will be collected at baseline and then at the following post-operative assessment points: 2 weeks, 6 weeks and 1 year. Postal questionnaire outcome data will be collected at 3 and 6 months. The primary outcome measure will be the Olerud Molander Ankle Score (OMAS) at 1 year following surgery. Secondary outcome measures will include the Manchester-Oxford Foot Questionnaire (MOXFQ), EuroQol-5D (EQ-5D), pain, treatment satisfaction, time to return to activity, operative tourniquet time, and complications. Discussion There is only one previous randomised trial comparing non-fixation with fixation of associated medial malleolus fractures but that was limited by the lack of baseline patient-reported outcome data and an inferior sample size. This current prospective trial aims to provide high-quality evidence regarding the requirement for medial malleolar fixation in unstable ankle fractures. Trial registration ClinicalTrials.gov, NCT03362229. Registered retrospectively on 5 December 2017.

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Evaluation of three patient reported outcome measures following operative fixation of closed ankle fractures

Cited by 33 publications

References 26 publications

Compared to conventional physiotherapy, does the use of an ankle trainer device after Weber B ankle fracture operation improve outcome and shorten hospital stay? A randomized controlled trial

Compared to conventional physiotherapy, does the use of an ankle trainer device after Weber B ankle fracture operation improve outcome and shorten hospital stay? A randomized controlled trial

Primary outcome measures used in interventional trials for ankle fractures: a systematic review

Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle

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