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

This study has been withdrawn prior to enrollment.
(Funding problems)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01488175
First Posted: December 8, 2011
Last Update Posted: March 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Morten Grove Thomsen, Hvidovre University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Morten Grove Thomsen, Hvidovre University Hospital:

Primary Outcome Measures:
  • migration of the prosthesis in millimeters assessed vith RSA. [ Time Frame: 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:
  • postoperative pain. [ Time Frame: 2 years ]
    Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion

  • Patient satisfaction (VAS-scale) [ Time Frame: 2 years ]
    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 ]
    Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion


Enrollment: 0
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488175


Locations
Denmark
Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.
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

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
First Submitted: December 2, 2011
First Posted: December 8, 2011
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Morten Grove Thomsen, Hvidovre University Hospital:
TKA
RSA
Tourniquet
Arthroplasty
Knee

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