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

NCT ID: NCT04469166

Last Updated: 2020-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-01

Study Completion Date

2020-03-30

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.

Conditions

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Use of Tourniquet in Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double blinded study

Study Groups

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Tourniquet

Group of tourniquet

Group Type ACTIVE_COMPARATOR

tourniquet

Intervention Type PROCEDURE

Use of tourniquet

No tourniquet

Group of no tourniquet

Group Type ACTIVE_COMPARATOR

No tourniquet

Intervention Type PROCEDURE

No use of tourniquet

Interventions

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tourniquet

Use of tourniquet

Intervention Type PROCEDURE

No tourniquet

No use of tourniquet

Intervention Type PROCEDURE

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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hawler Medical University

OTHER

Sponsor Role lead

Responsible Party

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Sherwan Ahmed Ali Hamawandi

Assistant professor of orthopedic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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HMU/Sherwan 10

Identifier Type: -

Identifier Source: org_study_id

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