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The proximal hamstring avulsion clinical trial (PHACT)-a randomised controlled non-inferiority trial of operative versus non-operative treatment of proximal hamstrings avulsions: study protocol
Karolinska Inst, Karolinska Inst Danderyds Sjukhus, Stockholm, Sweden.ORCID iD: 0000-0002-2387-6721
Haukeland Hosp, Dept Orthopaed Surg, Bergen, Norway.
Oslo Univ Hosp, Div Orthopaed Surg, Oslo, Norway.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
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2019 (English)In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 9, no 9, article id e031607Article in journal (Refereed) Published
Abstract [en]

Introduction The treatment of proximal hamstring avulsions is controversial. While several trials have investigated the outcome for patients treated surgically, there is today no prospective trial comparing operative treatment with non-operative treatment. This protocol describes the design for the proximal hamstring avulsion clinical trial (PHACT)-the first randomised controlled trial of operative versus non-operative treatment for proximal hamstring avulsions. Methods and analysis PHACT is a multicentre randomised controlled trial conducted across Sweden, Norway and Finland. Eligible patients (60 participants/treatment arm) with a proximal hamstring avulsion of at least two of three tendons will be randomised to either operative or non-operative treatment. Participants allocated to surgery will undergo reinsertion of the tendons with suture anchors. The rehabilitation programme will be the same for both treatment groups. When patient or surgeon equipoise for treatment alternatives cannot be reached and randomisation therefore is not possible, patients will be invited to participate in a parallel observational non-randomised cohort. The primary outcome will be the patient-reported outcome measure Perth hamstring assessment tool at 24 months. Secondary outcomes include the Lower Extremity Functional Score, physical performance and muscle strength tests, patient satisfaction and MR imaging. Data analysis will be blinded and intention-to-treat analysis will be preformed. Ethics and dissemination Ethical approval has been granted by the Ethical Committee of Uppsala University (DNR: 2017-170) and by the Norwegian ethical board (REC: 2017/1911). The study will be conducted in agreement with the Helsinki declaration. The findings will be disseminated in peer-reviewed publications.

Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2019. Vol. 9, no 9, article id e031607
Keywords [en]
hamstring, hamstring tendons, randomized controlled trial, MRI, patient-reported outcome meassure, muscle strength
National Category
Orthopaedics
Identifiers
URN: urn:nbn:se:uu:diva-400101DOI: 10.1136/bmjopen-2019-031607ISI: 000497787600385PubMedID: 31519683OAI: oai:DiVA.org:uu-400101DiVA, id: diva2:1380896
Available from: 2019-12-19 Created: 2019-12-19 Last updated: 2019-12-19Bibliographically approved

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