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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04469166
Enrollment
101
Registered
2020-07-13
Start date
2014-03-01
Completion date
2020-03-30
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Use of Tourniquet in Total Knee Arthroplasty

Keywords

Tourniquet, Total knee arthroplasty, Clinical outcomes, Functional outcomes

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.

Interventions

PROCEDUREtourniquet

Use of tourniquet

PROCEDURENo tourniquet

No use of tourniquet

Sponsors

Hawler Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Double blinded study

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Knee society scoreThis score was assessed at 5 years postoperativelyKnee society score for functional outcome which will be low in poor function and high in best function
Knee injury and osteoarthritis outcome scoresThis score was assessed at 5 years post-operativelyKnee injury and osteoarthritis outcome score which will be low in poor function and high in better function
VAS for thigh painThis score was assessed at 1st day post-operativelyVisual analogue scale for thigh pain which will be high in more pain and low in less pain

Secondary

MeasureTime frameDescription
Post operative complicationsThese complications as bleeding, infection, Deep venous thrombosis and revision are assessed at postoperative period.The complications can occurred after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026