Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up

Study Overview
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Brief Summary
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This study is randomized controlled trial with 5 years follow up and involved 101 patients divided in two groups; group A in which tourniquet was used in total knee arthroplasty while group B in which tourniquet was not used. All these patients were analyzed for the clinical and functional outcome measures.

Detailed Description
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In this study, investigators have primary outcome measures and secondary outcome measures which were assessed in multiple periods to see the effects of using tourniquet in total knee arthroplasty on the clinical and functional outcomes with follow up of 5 years.

Official Title
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Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up: a Randomized Controlled Trial

Conditions
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Use of Tourniquet in Total Knee Arthroplasty

Intervention / Treatment
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* Procedure: tourniquet
* Procedure: No tourniquet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Grade 3 and 4 osteoarthritis age 55-80 years patients agree to participate in the study Exclusion Criteria: Smoking Diabetes mellitus .Symptomatic spinal pathology with moderate to severe cervical or lumbosacral spinal stenosis. Hip pathology like osteoarthritis or fractures Neuromuscular disorders Blood dyscrasia or anticoagulant treatment .Body mass index equal to 30 or more. Previous knee surgery or knee infection Peripheral vascular disease Rheumatoid arthritis Hemoglobin less than 12 gram/deciliter

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tourniquet<br>Group of tourniquet | Procedure: tourniquet<br>* Use of tourniquet<br>|
| Active Comparator: No tourniquet<br>Group of no tourniquet | Procedure: No tourniquet<br>* No use of tourniquet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee society score | Knee society score for functional outcome which will be low in poor function and high in best function | This score was assessed at 5 years postoperatively | 
| Knee injury and osteoarthritis outcome scores | Knee injury and osteoarthritis outcome score which will be low in poor function and high in better function | This score was assessed at 5 years post-operatively | 
| VAS for thigh pain | Visual analogue scale for thigh pain which will be high in more pain and low in less pain | This score was assessed at 1st day post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative complications | The complications can occurred after surgery | These complications as bleeding, infection, Deep venous thrombosis and revision are assessed at postoperative period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional outcomes, Tourniquet, Total knee arthroplasty, Clinical outcomes