Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty
1 other identifier
interventional
80
1 country
1
Brief Summary
Background: Osteoarthritis (OA) is the most common joint disease that causes symptomatic health problems in the elderly population. For some patients with knee OA, total knee arthroplasty (TKA) may be the only option that offers the possibility of reestablishing the patient's life quality. Surgery of TKA usually takes place in a complete bloodless field established by a tourniquet around the thigh. The method aims to reduce blood loss and give the surgeon better visibility during the operation. The method is, however, not without side effects as patients often experience severe pain and swollen leg in the time after surgery. Furthermore, has the method shown decidedly muscle- and nerve damage followed by prolonged rehabilitation and reduced physical function. It is, however, possible to perform the operation without the use of the tourniquet. Aim and hypothesis: The aim of the present study is to assess the effects of tourniquet use in TKA on physical function, early rehabilitation, pain and opioid consumption. Hypotheses H1: TKA without tourniquet leads to better physical function and early rehabilitation. H2: TKA without tourniquet causes less pain and opioid consumption H3: Recovery of mechanical lower limb function post TKA is faster without use of tourniquet. Methods: 80 patients (40 in each group) all eligible for TKA will be consecutively recruited and randomized to A) TKA without tourniquet, B) TKA with tourniquet. Subjects will be evaluated before the operation (baseline) and 14 days, 3, 6 and 12 months after the operation. The primary outcome will be the change from baseline to 3 months in self-administered knee-function (KOOS-ADL subscale). Further, will we examine a number of pre-specified secondary outcomes, which include self-rated knee-related pain, symptoms, difficulty with sports and leisure activities, and quality of life. In addition, muscle function, physical performance, and the use of pain medication will be studied Impact of the project: The project design of this study will enable analyses for determining the impact of operating without tourniquet and whether such an intervention can in fact improve physical function, performance and quality of life within TKA patients. The results may impact notably on the patient level and possible redefine current surgical strategies. The societal perspective of the project is to remobilize patients faster, which may reduce hospital services and absence from work.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started Sep 2013
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2013
CompletedFirst Posted
Study publicly available on registry
July 3, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJuly 3, 2013
June 1, 2013
1.2 years
June 21, 2013
June 27, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change in self reported physical function. Assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire subscale for, Function in Daily Living (ADL).
Further assessments: Baseline, 14 days and a 6 and 12 months follow up. KOOS is a patient-reported outcome measure with good evidence of reliability, validity and responsiveness in different population with varying pathologies, injury durations, and activity levels (http://www.koos.nu).
Endpoint 3 months
Secondary Outcomes (3)
Change in the Knee injury and Osteoarthritis Outcome Score (KOOS)
Baseline, 14 days, 3 months (endpoint) and a 6 and 12 months follow up
Global perceived effect (GPE) score
3 months (endpoint) and a 6 and 12 months follow up
Change in physical performance (battery).
Baseline, 3 and 14 days, 3 months (endpoint) and a 6 months follow up
Other Outcomes (4)
Change in mechanical muscle function
Baseline, 3 and 6 months
Change in 30-sec Maximal Repeated Unilateral Knee Bending
Baseline, 3 and 6 months
Change in Pain
Baseline and 1-14 days
- +1 more other outcomes
Study Arms (2)
Non-tourniquet assisted TKA
EXPERIMENTALTourniquet assisted TKA
OTHERInterventions
The intervention group will undergo non-tourniquet assisted total knee arthroplasty, which means that blood flow to the lower limb is maintained throughout surgery.
The procedure involves the use of a tourniquet around the thigh. During surgery the tourniquet will be inflated above the systolic blood pressure to ensure a complete bloodless surgical field.
Eligibility Criteria
You may qualify if:
- Knee Osteoarthritis both clinically and radiologically according to the "Ahlbäck classification system".
- Patients who can tolerate spinal anesthesia
You may not qualify if:
- Patients with rheumatoid arthritis.
- Patients with BMI \> 35.
- History of major knee operations.
- Malignancy.
- Known muscle disease.
- History of deep vain thrombosis (DVT), or other blood coagulation disorders.
- Symptomatic bilateral OA, with planned surgery of the contra lateral knee within a year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Denmarklead
- The Danish Rheumatism Associationcollaborator
- Bevica Fondencollaborator
Study Sites (1)
Odense University Hospital
Odense, 5000, Denmark
Related Publications (1)
Lohmann-Jensen R, Holsgaard-Larsen A, Emmeluth C, Overgaard S, Jensen C. The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2014 Mar 29;15:110. doi: 10.1186/1471-2474-15-110.
PMID: 24678741DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rasmus Lohmann-Jensen, Cand. Scient
Odense University Hospital and University of Southern Denmark
- STUDY CHAIR
Søren Overgaard, Professor
Odense University Hospital and University of Southern Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc
Study Record Dates
First Submitted
June 21, 2013
First Posted
July 3, 2013
Study Start
September 1, 2013
Primary Completion
November 1, 2014
Study Completion
September 1, 2016
Last Updated
July 3, 2013
Record last verified: 2013-06