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. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014