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

Not Applicable

Completed

• Conditions: Use of Tourniquet in Total Knee Arthroplasty
• Interventions: Procedure: tourniquet; Procedure: No tourniquet

• Registration Number: NCT04469166
• Lead Sponsor: Hawler Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-03-01
• Primary Completion: 2020-03-20
• Study Completion: 2020-03-30
• Status Verified: 2020-07
• Study First Submitted: 2020-07-03
• Study First Submitted QC: 2020-07-10
• Last Update Submitted: 2020-07-10
• Study First Posted: 2020-07-13
• Last Update Posted: 2020-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tourniquet	tourniquet	Group of tourniquet
No tourniquet	No tourniquet	Group of no tourniquet

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Post operative complications	These complications as bleeding, infection, Deep venous thrombosis and revision are assessed at postoperative period.	The complications can occurred after surgery