Does Tourniquet Use in Total Knee Replacement Improve Fixation

Study Overview
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Brief Summary
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Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby improve fixation, it might also cause complications. Migration as measured by RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use of a tourniquet influences fixation measured with RSA.

Detailed Description
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The use of a tourniquet during total knee replacement (TKA) is a generally accepted routine at many departments. It is thought to facilitate dissection and reduce peroperative bleeding, but the main argument for its use is that bleeding bone surfaces might impair the fixation of cemented prostheses, because of less cement penetration. We investigate in a RCT 50 patient with radiostereometric analysis, where 25 is randomized to a tourniquet during the hole operation and 25 are not. Primary outcome is MTPM, a meassure of migration(loosening) of the kneeprosthesis. Secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self assesed knee score (KOOS) Total follow up time 2 years

Official Title
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Does Tourniquet Use in Total Knee Replacement Improve Fixation

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: No use of tourniquet
* Procedure: Tourniquet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary or secondary osteoarthritis without other severe disease (ASA 1-2). Exclusion Criteria: were inability to give informed consent, rheumatic arthritis, malignancy, coagulation disorder or medical treatment influencing the coagulation, liver disease, severe heart disease or bilateral operation.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: No Tourniquet<br>We compare tourniquet or not in knee surgery | Procedure: No use of tourniquet<br>* Tourniquet is not applied i 25 pts<br>* Other names: No Tourniquet;|
| Active Comparator: Tourniquet<br>We compare tourniquet or not in knee surgery | Procedure: Tourniquet<br>* Use of tourniquet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| View protocol record | Measures the migration of the knee prosthesis | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| View Protocol Record | Meassures of total bledding, ROM, KOOS, Pain | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee, Tourniquet, Blood loss, pain, range of motion