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

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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

Pihl, Elsa (author): Karolinska Institutet

Kristoffersen, Malfrid Holen (author): Haukeland Hosp, Dept Orthopaed Surg, Bergen, Norway

Rosenlund, Anne-Mari (author): Oslo Univ Hosp, Div Orthopaed Surg, Oslo, Norway

Laszlo, Sofia (author): Uppsala universitet,Ortopedi,Uppsala Univ Hosp, Sweden

Berglof, Mida (author): Karolinska Inst, Karolinska Inst Danderyds Sjukhus, Stockholm, Sweden

Ribom, Eva (author): Uppsala universitet,Ortopedi,Uppsala Univ Hosp, Sweden

Eriksson, Karl (author): Karolinska Institutet

Frihagen, Frede (author): Oslo Univ Hosp, Div Orthopaed Surg, Oslo, Norway

Mattila, Ville M. (author): Tampere Univ Hosp, Dept Orthopaed, Tampere, Finland

Schilcher, Jörg (author): Linköpings universitet,Avdelningen för Kirurgi, Ortopedi och Onkologi,Medicinska fakulteten,Region Östergötland, Ortopedkliniken i Linköping

Eklund, Martin (author): Karolinska Institutet

Snellman, Greta, 1978- (author): Uppsala universitet,Ortopedi,Uppsala Univ Hosp, Sweden

Skorpil, Mikael (author): Karolinska Institutet

Skoldenberg, Olof (author): Karolinska Institutet

Hedbeck, Carl Johan (author): Karolinska Inst, Karolinska Inst Danderyds Sjukhus, Stockholm, Sweden

Jonsson, Kenneth (author): Uppsala universitet,Ortopedi,Uppsala Univ Hosp, Sweden

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(creator_code:org_t)

2019-09-13
2019
English.
In: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 9:9

Related links:: https://doi.org/10.1...; show more...; https://uu.diva-port... (primary) (Raw object); https://bmjopen.bmj....; https://liu.diva-por... (primary) (Raw object); https://urn.kb.se/re...; https://doi.org/10.1...; https://urn.kb.se/re...; http://kipublication...; show less...

Journal article (peer-reviewed)

Abstract Subject headings

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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Ortopedi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Orthopaedics (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)

Keyword

hamstring
hamstring tendons
randomized controlled trial
MRI
patient-reported outcome meassure
muscle strength

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ref (subject category)
art (subject category)

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By the author/editor: Pihl, Elsa; Kristoffersen, M ...; Rosenlund, Anne- ...; Laszlo, Sofia; Berglof, Mida; Ribom, Eva; show more...; Eriksson, Karl; Frihagen, Frede; Mattila, Ville M ...; Schilcher, Jörg; Eklund, Martin; Snellman, Greta, ...; Skorpil, Mikael; Skoldenberg, Olo ...; Hedbeck, Carl Jo ...; Jonsson, Kenneth; show less...

About the subject

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Orthopaedics

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Surgery

Articles in the publication: BMJ Open

By the university: Uppsala University; Linköping University; Karolinska Institutet

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