Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty: A Randomized Controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Non-tourniquet assisted TKA
* Procedure: Tourniquet assisted TKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Knee Osteoarthritis both clinically and radiologically according to the Ahlbäck classification system. Patients who can tolerate spinal anesthesia Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-tourniquet assisted TKA<br> | Procedure: Non-tourniquet assisted TKA<br>* The intervention group will undergo non-tourniquet assisted total knee arthroplasty, which means that blood flow to the lower limb is maintained throughout surgery.<br>|
| Other: Tourniquet assisted TKA<br> | Procedure: Tourniquet assisted TKA<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Knee injury and Osteoarthritis Outcome Score (KOOS) | The remaining 4 subscales for pain, other symptoms, function in sport and recreation, and knee related quality of life. | Baseline, 14 days, 3 months (endpoint) and a 6 and 12 months follow up | 
| Global perceived effect (GPE) score | In addition to pain and physical function the assessment by the patient of a global perceived effect of the treatment is a recommended responder criterion [4]. Patients will be asked to rate possible change in their condition since the initial administration (baseline) on a 7-point Likert-scale. | 3 months (endpoint) and a 6 and 12 months follow up | 
| Change in physical performance (battery). | Physical performance-based measures will include; Passive knee range of motion, 30 s chair stand (number completed), 20 m normal-paced and fast-paced walk (time in sec.), and timed up and go (time in sec.) | Baseline, 3 and 14 days, 3 months (endpoint) and a 6 months follow up |