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The proximal hamstr...
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Pihl, ElsaKarolinska Institutet
(author)
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
- Article/chapterEnglish2019
Publisher, publication year, extent ...
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2019-09-13
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BMJ Publishing Group Ltd,2019
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electronicrdacarrier
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LIBRIS-ID:oai:DiVA.org:uu-400101
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-400101URI
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https://doi.org/10.1136/bmjopen-2019-031607DOI
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https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-162772URI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:142381172URI
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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Funding Agencies|AFA Insurance; Centrum for idrottsforskning, CIF [P2019-0155]; Landstingets Omsesidiga Forsakringsbolag, LOF; Ostergotland County Council
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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.
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Kristoffersen, Malfrid HolenHaukeland Hosp, Dept Orthopaed Surg, Bergen, Norway
(author)
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Rosenlund, Anne-MariOslo Univ Hosp, Div Orthopaed Surg, Oslo, Norway
(author)
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Laszlo, SofiaUppsala universitet,Ortopedi,Uppsala Univ Hosp, Sweden(Swepub:uu)sofla843
(author)
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Berglof, MidaKarolinska Inst, Karolinska Inst Danderyds Sjukhus, Stockholm, Sweden
(author)
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Ribom, EvaUppsala universitet,Ortopedi,Uppsala Univ Hosp, Sweden(Swepub:uu)evlri676
(author)
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Eriksson, KarlKarolinska Institutet
(author)
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Frihagen, FredeOslo Univ Hosp, Div Orthopaed Surg, Oslo, Norway
(author)
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Mattila, Ville M.Tampere Univ Hosp, Dept Orthopaed, Tampere, Finland
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Schilcher, JörgLinköpings universitet,Avdelningen för Kirurgi, Ortopedi och Onkologi,Medicinska fakulteten,Region Östergötland, Ortopedkliniken i Linköping(Swepub:liu)jorsc03
(author)
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Eklund, MartinKarolinska Institutet
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Snellman, Greta,1978-Uppsala universitet,Ortopedi,Uppsala Univ Hosp, Sweden(Swepub:uu)gresn966
(author)
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Skorpil, MikaelKarolinska Institutet
(author)
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Skoldenberg, OlofKarolinska Institutet
(author)
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Hedbeck, Carl JohanKarolinska Inst, Karolinska Inst Danderyds Sjukhus, Stockholm, Sweden
(author)
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Jonsson, KennethUppsala universitet,Ortopedi,Uppsala Univ Hosp, Sweden(Swepub:uu)kennjons
(author)
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Karolinska InstitutetHaukeland Hosp, Dept Orthopaed Surg, Bergen, Norway
(creator_code:org_t)
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Laszlo, Sofia
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Eriksson, Karl
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