The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol
Identifieur interne : 000081 ( Main/Exploration ); précédent : 000080; suivant : 000082The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol
Auteurs : Rasmus Lohmann-Jensen [Danemark] ; Anders Holsgaard-Larsen [Danemark] ; Claus Emmeluth [Danemark] ; S Ren Overgaard [Danemark] ; Carsten Jensen [Danemark]Source :
- BMC Musculoskeletal Disorders [ 1471-2474 ] ; 2014.
Abstract
Surgical treatment of osteoarthritis with total knee arthroplasty (TKA) usually takes place in a complete bloodless field using a tourniquet. However, doing the surgery without a tourniquet may reduce muscle damage, post-surgery pain and led to improved functional rehabilitation and mobilization.
A prospective, blinded, parallel-group, controlled superiority trial, with balanced randomization [1:1]. Patients aged 50 or older eligible for primary TKA for osteoarthritis will be consecutively recruited from Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. A total of 80 patients will be randomly allocated to TKA with or without tourniquet application providing 40 patients for each of the two treatment arms. The tourniquet assisted TKA group will have an automatic, micro-processor-based pneumatic tourniquet inflated around the thigh during surgery. The non-tourniquet assisted TKA group will have surgery performed without application of a tourniquet. The primary aim is to compare tourniquet assisted to non-tourniquet assisted TKA on patient-reported physical function (KOOS-ADL). The secondary aim is to compare post-surgery pain, function in sports and recreation, quality of life, and performance-based physical function. The explorative outcomes include; use of pain medication, single-fiber muscle damage, and changes in mechanical muscle function. The primary endpoint will be at 3-months following surgical treatment, and the time-point for analysis of the primary outcome. However, follow-up will continue up to 1 year, and provide medium-term results. The treatment effect (difference in KOOS-ADL) will be analyzed using a random effects regression model, crude and adjusted results will be reported, if needed. Analyses will be based on the intention-to-treat (ITT). Subsequent per-protocol analysis may be necessary in the event of a substantial number of patients (> 15%) being lost during follow-up. The number needed to treat (NNT) for a positive effect of treatment (>10 points on KOOS-ADL) will be reported.
This is the first randomized clinical trial comparing the efficacy of tourniquet assisted TKA on patient-reported physical function supported by a range of performance-based secondary outcome measures. As such it will provide high quality evidence that may help determine whether tourniquet should be used in future TKA procedures in patients with osteoarthritis of the knee.
ClinicalTrials
Url:
DOI: 10.1186/1471-2474-15-110
PubMed: 24678741
PubMed Central: 3978123
Affiliations:
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protocol</title><author><name sortKey="Lohmann Jensen, Rasmus" sort="Lohmann Jensen, Rasmus" uniqKey="Lohmann Jensen R" first="Rasmus" last="Lohmann-Jensen">Rasmus Lohmann-Jensen</name><affiliation wicri:level="1"><nlm:aff id="I1">Orthopaedic Research Unit, Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense C, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Orthopaedic Research Unit, Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense C</wicri:regionArea><wicri:noRegion>Odense C</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="I2">Institute of Clinical Research, University of Southern Denmark, Odense C, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Institute of Clinical Research, University of Southern Denmark, Odense C</wicri:regionArea><wicri:noRegion>Odense C</wicri:noRegion></affiliation></author><author><name sortKey="Holsgaard Larsen, Anders" sort="Holsgaard Larsen, Anders" uniqKey="Holsgaard Larsen A" first="Anders" last="Holsgaard-Larsen">Anders Holsgaard-Larsen</name><affiliation wicri:level="1"><nlm:aff id="I1">Orthopaedic Research Unit, Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense C, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Orthopaedic Research Unit, Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense C</wicri:regionArea><wicri:noRegion>Odense C</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="I2">Institute of Clinical Research, University of Southern Denmark, Odense C, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Institute of Clinical Research, University of Southern Denmark, Odense C</wicri:regionArea><wicri:noRegion>Odense C</wicri:noRegion></affiliation></author><author><name sortKey="Emmeluth, Claus" sort="Emmeluth, Claus" uniqKey="Emmeluth C" first="Claus" last="Emmeluth">Claus Emmeluth</name><affiliation wicri:level="1"><nlm:aff id="I1">Orthopaedic Research Unit, Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense C, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Orthopaedic Research Unit, Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense C</wicri:regionArea><wicri:noRegion>Odense C</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="I2">Institute of Clinical Research, University of Southern Denmark, Odense C, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Institute of Clinical Research, University of Southern Denmark, Odense C</wicri:regionArea><wicri:noRegion>Odense C</wicri:noRegion></affiliation></author><author><name sortKey="Overgaard, S Ren" sort="Overgaard, S Ren" uniqKey="Overgaard S" first="S Ren" last="Overgaard">S Ren Overgaard</name><affiliation wicri:level="1"><nlm:aff id="I1">Orthopaedic Research Unit, Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense C, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Orthopaedic Research Unit, Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense C</wicri:regionArea><wicri:noRegion>Odense C</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="I2">Institute of Clinical Research, University of Southern Denmark, Odense C, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Institute of Clinical Research, University of Southern Denmark, Odense C</wicri:regionArea><wicri:noRegion>Odense C</wicri:noRegion></affiliation></author><author><name sortKey="Jensen, Carsten" sort="Jensen, Carsten" uniqKey="Jensen C" first="Carsten" last="Jensen">Carsten Jensen</name><affiliation wicri:level="1"><nlm:aff id="I1">Orthopaedic Research Unit, Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense C, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Orthopaedic Research Unit, Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense C</wicri:regionArea><wicri:noRegion>Odense C</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="I2">Institute of Clinical Research, University of Southern Denmark, Odense C, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Institute of Clinical Research, University of Southern Denmark, Odense C</wicri:regionArea><wicri:noRegion>Odense C</wicri:noRegion></affiliation></author></analytic><series><title level="j">BMC Musculoskeletal Disorders</title><idno type="eISSN">1471-2474</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Surgical treatment of osteoarthritis with total knee arthroplasty (TKA) usually takes place in a complete bloodless field using a tourniquet. However, doing the surgery without a tourniquet may reduce muscle damage, post-surgery pain and led to improved functional rehabilitation and mobilization.</p></sec><sec><title>Methods/Design</title><p>A prospective, blinded, parallel-group, controlled superiority trial, with balanced randomization [1:1]. Patients aged 50 or older eligible for primary TKA for osteoarthritis will be consecutively recruited from Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. A total of 80 patients will be randomly allocated to TKA with or without tourniquet application providing 40 patients for each of the two treatment arms. The tourniquet assisted TKA group will have an automatic, micro-processor-based pneumatic tourniquet inflated around the thigh during surgery. The non-tourniquet assisted TKA group will have surgery performed without application of a tourniquet. The primary aim is to compare tourniquet assisted to non-tourniquet assisted TKA on patient-reported physical function (KOOS-ADL). The secondary aim is to compare post-surgery pain, function in sports and recreation, quality of life, and performance-based physical function. The explorative outcomes include; use of pain medication, single-fiber muscle damage, and changes in mechanical muscle function. The primary endpoint will be at 3-months following surgical treatment, and the time-point for analysis of the primary outcome. However, follow-up will continue up to 1 year, and provide medium-term results. The treatment effect (difference in KOOS-ADL) will be analyzed using a random effects regression model, crude and adjusted results will be reported, if needed. Analyses will be based on the intention-to-treat (ITT). Subsequent per-protocol analysis may be necessary in the event of a substantial number of patients (> 15%) being lost during follow-up. The number needed to treat (NNT) for a positive effect of treatment (>10 points on KOOS-ADL) will be reported.</p></sec><sec><title>Discussion</title><p>This is the first randomized clinical trial comparing the efficacy of tourniquet assisted TKA on patient-reported physical function supported by a range of performance-based secondary outcome measures. As such it will provide high quality evidence that may help determine whether tourniquet should be used in future TKA procedures in patients with osteoarthritis of the knee.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials
<ext-link ext-link-type="uri" xlink:href="http://www.biomedcentral.com/1471-2474/15/110">NCT01891266</ext-link>.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Brooks, Pm" uniqKey="Brooks P">PM Brooks</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Izquierdo, M" uniqKey="Izquierdo M">M Izquierdo</name></author><author><name sortKey="Aguado, X" uniqKey="Aguado X">X Aguado</name></author><author><name sortKey="Gonzalez, R" uniqKey="Gonzalez R">R Gonzalez</name></author><author><name sortKey="Lopez, Jl" uniqKey="Lopez J">JL Lopez</name></author><author><name sortKey="Hakkinen, K" uniqKey="Hakkinen K">K Hakkinen</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Salaffi, F" uniqKey="Salaffi F">F Salaffi</name></author><author><name sortKey="Carotti, M" uniqKey="Carotti M">M Carotti</name></author><author><name sortKey="Stancati, A" uniqKey="Stancati A">A 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sort="Lohmann Jensen, Rasmus" uniqKey="Lohmann Jensen R" first="Rasmus" last="Lohmann-Jensen">Rasmus Lohmann-Jensen</name></noRegion><name sortKey="Emmeluth, Claus" sort="Emmeluth, Claus" uniqKey="Emmeluth C" first="Claus" last="Emmeluth">Claus Emmeluth</name><name sortKey="Emmeluth, Claus" sort="Emmeluth, Claus" uniqKey="Emmeluth C" first="Claus" last="Emmeluth">Claus Emmeluth</name><name sortKey="Holsgaard Larsen, Anders" sort="Holsgaard Larsen, Anders" uniqKey="Holsgaard Larsen A" first="Anders" last="Holsgaard-Larsen">Anders Holsgaard-Larsen</name><name sortKey="Holsgaard Larsen, Anders" sort="Holsgaard Larsen, Anders" uniqKey="Holsgaard Larsen A" first="Anders" last="Holsgaard-Larsen">Anders Holsgaard-Larsen</name><name sortKey="Jensen, Carsten" sort="Jensen, Carsten" uniqKey="Jensen C" first="Carsten" last="Jensen">Carsten Jensen</name><name sortKey="Jensen, Carsten" sort="Jensen, Carsten" uniqKey="Jensen C" first="Carsten" last="Jensen">Carsten Jensen</name><name sortKey="Lohmann Jensen, Rasmus" sort="Lohmann Jensen, Rasmus" uniqKey="Lohmann Jensen R" first="Rasmus" last="Lohmann-Jensen">Rasmus Lohmann-Jensen</name><name sortKey="Overgaard, S Ren" sort="Overgaard, S Ren" uniqKey="Overgaard S" first="S Ren" last="Overgaard">S Ren Overgaard</name><name sortKey="Overgaard, S Ren" sort="Overgaard, S Ren" uniqKey="Overgaard S" first="S Ren" last="Overgaard">S Ren Overgaard</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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