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

Osteoarthritis of the Knee Clinical Trial

Official title:

Clinical and Stereoradiological Comparison of the Results After Primary TKA Inserted With or Without the Use of a Tourniquet

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01488175
• Other study ID #: H-2-2011-100
• Status: Withdrawn
• Phase: Phase 4
• First received: December 2, 2011
• Last updated: March 17, 2015
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: National Board of HealthDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Procedure:
• tourniquet
a tourniquet around the thigh is used during insertion of the TKA to achieve a bloodless environment
• no tourniquet
a tourniquet around the thigh is not used during insertion of the TKA

Locations

Country	Name	City	State
Denmark	Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	migration of the prosthesis in millimeters assessed vith RSA.	does the use of a tourniquet around the thigh during insertion of a primary TKA affect postoperative migration of the prosthesis?	2 years	No
Secondary	postoperative pain.	Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion	2 years	No
Secondary	Patient satisfaction (VAS-scale)	Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion	2 years	No
Secondary	Knee range of motion (degrees)	Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion	2 years	No