Does Tourniquet Use in Total Knee Replacement Improve Fixation

Phase 3

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: No use of tourniquet; Procedure: Tourniquet

• Registration Number: NCT01470482
• Lead Sponsor: Per Aspenberg

Brief Summary

Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby improve fixation, it might also cause complications. Migration as measured by RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use of a tourniquet influences fixation measured with RSA.

Detailed Description

The use of a tourniquet during total knee replacement (TKA) is a generally accepted routine at many departments. It is thought to facilitate dissection and reduce peroperative bleeding, but the main argument for its use is that bleeding bone surfaces might impair the fixation of cemented prostheses, because of less cement penetration.

We investigate in a RCT 50 patient with radiostereometric analysis, where 25 is randomized to a tourniquet during the hole operation and 25 are not.

Primary outcome is MTPM, a meassure of migration(loosening) of the kneeprosthesis.

Secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self assesed knee score (KOOS) Total follow up time 2 years

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• primary or secondary osteoarthritis without other severe disease (ASA 1-2).

Exclusion Criteria

• were inability to give informed consent,
• rheumatic arthritis,
• malignancy,
• coagulation disorder or medical treatment influencing the coagulation,
• liver disease,
• severe heart disease or bilateral operation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Tourniquet	No use of tourniquet	We compare tourniquet or not in knee surgery
Tourniquet	Tourniquet	We compare tourniquet or not in knee surgery

Primary Outcome Measures

Name	Time	Method
View protocol record	2 years	Measures the migration of the knee prosthesis

Secondary Outcome Measures

Name	Time	Method
View Protocol Record	2 years	Meassures of total bledding, ROM, KOOS, Pain

Trial Locations

Locations (1)

Motala hospital; 🇸🇪 Motala, Sweden