Clinical and Stereoradiological Comparison of the Results After Primary Cemented Total Knee Arthroplasty Inserted With or Without the Use of a Tourniquet

Phase 4

Withdrawn

• Conditions: Osteoarthritis of the Knee
• Interventions: Procedure: no tourniquet; Procedure: tourniquet

• Registration Number: NCT01488175
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

The purpose of this study is to investigate if the use of a tourniquet during insertion of a cemented primary total knee arthroplasty will influence clinical and radiological (measured with RSA X-ray technique) outcome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-08
• Study Start: 2012-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• clinical diagnosis og osteoarthritis of the knee
• patients must be 18 years or older
• patients must understand and speak danish
• must be able to give signed consent

Exclusion Criteria

• severe medical illness
• documented osteoporosis
• rheumatoid arthritis
• prior surgery in the knee
• neuropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
without tourniquet	no tourniquet	-
with tourniquet	tourniquet	-

Primary Outcome Measures

Name	Time	Method
migration of the prosthesis in millimeters assessed vith RSA.	2 years	does the use of a tourniquet around the thigh during insertion of a primary TKA affect postoperative migration of the prosthesis?

Secondary Outcome Measures

Name	Time	Method
postoperative pain.	2 years	Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
Patient satisfaction (VAS-scale)	2 years	Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
Knee range of motion (degrees)	2 years	Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion

Trial Locations

Locations (1)

Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.; 🇩🇰 Hvidovre, Denmark