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

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

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.

Study Overview

• Status: Completed
• Conditions: Use of Tourniquet in Total Knee Arthroplasty
• Intervention / Treatment: Procedure: tourniquet; Procedure: No tourniquet

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tourniquet; Group of tourniquet	Procedure: tourniquet; Use of tourniquet
Active Comparator: No tourniquet; Group of no tourniquet	Procedure: No tourniquet; No use of tourniquet

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Hawler Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 10, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; Tourniquet; Clinical outcomes; Functional outcomes
• Other Study ID Numbers: HMU/Sherwan 10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Upon the publication of our study, I will decide to share my patients data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No