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

Use of Tourniquet in Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04469166
• Other study ID #: HMU/Sherwan 10
• Status: Completed
• Phase: N/A
• Start date: March 1, 2014
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2020
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 30, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Use of Tourniquet in Total Knee Arthroplasty

Intervention

Procedure:
• tourniquet
Use of tourniquet
• No tourniquet
No use of tourniquet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Post operative complications	The complications can occurred after surgery	These complications as bleeding, infection, Deep venous thrombosis and revision are assessed at postoperative period.