Cargando…

The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol

BACKGROUND: 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 mobi...

Descripción completa

Detalles Bibliográficos
Autores principales: Lohmann-Jensen, Rasmus, Holsgaard-Larsen, Anders, Emmeluth, Claus, Overgaard, Søren, Jensen, Carsten
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978123/
https://www.ncbi.nlm.nih.gov/pubmed/24678741
http://dx.doi.org/10.1186/1471-2474-15-110
_version_ 1782310517247836160
author Lohmann-Jensen, Rasmus
Holsgaard-Larsen, Anders
Emmeluth, Claus
Overgaard, Søren
Jensen, Carsten
author_facet Lohmann-Jensen, Rasmus
Holsgaard-Larsen, Anders
Emmeluth, Claus
Overgaard, Søren
Jensen, Carsten
author_sort Lohmann-Jensen, Rasmus
collection PubMed
description BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials NCT01891266.
format Online
Article
Text
id pubmed-3978123
institution National Center for Biotechnology Information
language English
publishDate 2014
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-39781232014-04-09 The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol Lohmann-Jensen, Rasmus Holsgaard-Larsen, Anders Emmeluth, Claus Overgaard, Søren Jensen, Carsten BMC Musculoskelet Disord Study Protocol BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials NCT01891266. BioMed Central 2014-03-29 /pmc/articles/PMC3978123/ /pubmed/24678741 http://dx.doi.org/10.1186/1471-2474-15-110 Text en Copyright © 2014 Lohmann-Jensen et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.
spellingShingle Study Protocol
Lohmann-Jensen, Rasmus
Holsgaard-Larsen, Anders
Emmeluth, Claus
Overgaard, Søren
Jensen, Carsten
The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol
title The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol
title_full The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol
title_fullStr The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol
title_full_unstemmed The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol
title_short The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol
title_sort efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978123/
https://www.ncbi.nlm.nih.gov/pubmed/24678741
http://dx.doi.org/10.1186/1471-2474-15-110
work_keys_str_mv AT lohmannjensenrasmus theefficacyoftourniquetassistedtotalkneearthroplastyonpatientreportedandperformancebasedphysicalfunctionarandomizedcontrolledtrialprotocol
AT holsgaardlarsenanders theefficacyoftourniquetassistedtotalkneearthroplastyonpatientreportedandperformancebasedphysicalfunctionarandomizedcontrolledtrialprotocol
AT emmeluthclaus theefficacyoftourniquetassistedtotalkneearthroplastyonpatientreportedandperformancebasedphysicalfunctionarandomizedcontrolledtrialprotocol
AT overgaardsøren theefficacyoftourniquetassistedtotalkneearthroplastyonpatientreportedandperformancebasedphysicalfunctionarandomizedcontrolledtrialprotocol
AT jensencarsten theefficacyoftourniquetassistedtotalkneearthroplastyonpatientreportedandperformancebasedphysicalfunctionarandomizedcontrolledtrialprotocol
AT lohmannjensenrasmus efficacyoftourniquetassistedtotalkneearthroplastyonpatientreportedandperformancebasedphysicalfunctionarandomizedcontrolledtrialprotocol
AT holsgaardlarsenanders efficacyoftourniquetassistedtotalkneearthroplastyonpatientreportedandperformancebasedphysicalfunctionarandomizedcontrolledtrialprotocol
AT emmeluthclaus efficacyoftourniquetassistedtotalkneearthroplastyonpatientreportedandperformancebasedphysicalfunctionarandomizedcontrolledtrialprotocol
AT overgaardsøren efficacyoftourniquetassistedtotalkneearthroplastyonpatientreportedandperformancebasedphysicalfunctionarandomizedcontrolledtrialprotocol
AT jensencarsten efficacyoftourniquetassistedtotalkneearthroplastyonpatientreportedandperformancebasedphysicalfunctionarandomizedcontrolledtrialprotocol