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ENROLLING BY INVITATION
NCT07905495
NA

Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet

Sponsor: Shifa International Hospital

View on ClinicalTrials.gov

Summary

This randomized controlled trial compared early outcomes after replacement of both knees during the same operation, with and without tourniquet use. A tourniquet was an inflatable cuff placed around the upper thigh and tightened during surgery to temporarily restrict blood flow. The study tested the hypothesis that tourniquet use would reduce blood loss during and after surgery, preserve hemoglobin levels, and reduce early postoperative pain. Hemoglobin was the protein in red blood cells that carried oxygen. The study was designed to include 84 patients aged 40-80 years at the Department of Orthopedic Surgery, Shifa International Hospital, Islamabad. Patients were randomly assigned to two equal groups of 42. One group underwent replacement of both knees with tourniquet use, while the other underwent the same procedure without tourniquet inflation. Both groups received standardized surgical care, pain management, blood clot prevention, and rehabilitation. The outcomes assessed were blood loss during surgery, blood collected through drains from both knees during the first 24 hours after surgery, hemoglobin levels at 24 hours, and the decrease from preoperative hemoglobin levels. Pain in each knee was assessed at 24 and 48 hours using a scale from 0, indicating no pain, to 10, indicating the worst possible pain. These measurements were compared between the two groups to assess the effect of tourniquet use on early recovery.

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2026-07-01

Completion Date

2027-01-30

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

PROCEDURE

Simultaneous Bilateral Total Knee Replacement with Tourniquet

Both knees were replaced during a single anesthetic session using cemented components. A pneumatic tourniquet was placed around the proximal thigh of each limb and inflated to 100 mmHg above systolic blood pressure immediately before the incision for that limb. Tourniquet release and hemostasis followed the standardized surgical protocol.

PROCEDURE

Simultaneous Bilateral Total Knee Replacement without Tourniquet

Both knees were replaced during a single anesthetic session using cemented components. Tourniquet cuffs were not inflated. Hemostasis was maintained throughout surgery using electrocautery and standard surgical techniques.

Locations (1)

Shifa International Hospital, Islamabad

Islamabad, Fedral, Pakistan