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OpenTrials
Completed

NCT Number: NCT04469166

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

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.

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Key information

Conditions

Use of Tourniquet in Total Knee Arthroplasty

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tourniquet

Procedure

Use of tourniquet

No tourniquet

Procedure

No use of tourniquet

Primary outcomes

  1. Knee society score

    Time frame: 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

  2. Knee injury and osteoarthritis outcome scores

    Time frame: 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

  3. VAS for thigh pain

    Time frame: 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 outcomes

  1. Post operative complications

    Time frame: These complications as bleeding, infection, Deep venous thrombosis and revision are assessed at postoperative period.

    The complications can occurred after surgery

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jul 13, 2020
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.