Text Size

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

This study is not yet open for participant recruitment.
Verified December 2011 by Hvidovre University Hospital
Sponsor:
Information provided by (Responsible Party):
Morten Grove Thomsen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01488175
First received: December 2, 2011
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
 Procedure: tourniquet
Procedure: no tourniquet
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Stereoradiological Comparison of the Results After Primary TKA Inserted With or Without the Use of a Tourniquet

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • migration of the prosthesis in millimeters assessed vith RSA. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    does the use of a tourniquet around the thigh during insertion of a primary TKA affect postoperative migration of the prosthesis?


Secondary Outcome Measures:
  • postoperative pain. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion

  • Patient satisfaction (VAS-scale) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion

  • Knee range of motion (degrees) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion


Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: with tourniquet Procedure: tourniquet
a tourniquet around the thigh is used during insertion of the TKA to achieve a bloodless environment
Placebo Comparator: without tourniquet Procedure: no tourniquet
a tourniquet around the thigh is not used during insertion of the TKA

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488175

Contacts
Contact: Morten G. Thomsen, M.D, +45 26742157 morten@grovethomsen.dk
Contact: Anders Troelsen, M.D, Ph.D a_troelsen@hotmail.com

Locations
Denmark
Dept. of Orthopedics, University Hospital of Hvidovre, Denmark. Not yet recruiting
Hvidovre, Denmark, 2650
Contact: Anders Troelsen, M.D., Ph.D         a_troelsen@hotmail.com    
Dept. of Orthopedics, University Hospital of Hvidovre, Denmark. Not yet recruiting
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Study Chair: Anders Troelsen, M.D, Ph.D Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.
  More Information

No publications provided

Responsible Party: Morten Grove Thomsen, Principal Investigator, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01488175     History of Changes
Other Study ID Numbers: H-2-2011-100
Study First Received: December 2, 2011
Last Updated: December 6, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: National Board of Health
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
TKA
RSA
Tourniquet
Arthroplasty
Knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013