Back to resultsClinical and Stereoradiological Comparison of the Results After Primary Cemented Total Knee Arthroplasty Inserted With or Without the Use of a Tourniquet
Primary Purpose
Osteoarthritis of the Knee
Status
Withdrawn
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
tourniquet
no tourniquet
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring TKA, RSA, Tourniquet, Arthroplasty, Knee
Eligibility 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
Sites / Locations
- Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
with tourniquet
without tourniquet
Arm Description
Outcomes
Primary Outcome Measures
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?
Secondary Outcome Measures
postoperative pain.
Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
Patient satisfaction (VAS-scale)
Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
Knee range of motion (degrees)
Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
Full Information
NCT ID
NCT01488175
First Posted
December 2, 2011
Last Updated
March 17, 2015
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01488175
Brief Title
Clinical and Stereoradiological Comparison of the Results After Primary Cemented Total Knee Arthroplasty Inserted With or Without the Use of a Tourniquet
Official Title
Clinical and Stereoradiological Comparison of the Results After Primary TKA Inserted With or Without the Use of a Tourniquet
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Funding problems
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
TKA, RSA, Tourniquet, Arthroplasty, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
with tourniquet
Arm Type
Active Comparator
Arm Title
without tourniquet
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
tourniquet
Intervention Description
a tourniquet around the thigh is used during insertion of the TKA to achieve a bloodless environment
Intervention Type
Procedure
Intervention Name(s)
no tourniquet
Intervention Description
a tourniquet around the thigh is not used during insertion of the TKA
Primary Outcome Measure Information:
Title
migration of the prosthesis in millimeters assessed vith RSA.
Description
does the use of a tourniquet around the thigh during insertion of a primary TKA affect postoperative migration of the prosthesis?
Time Frame
2 years
Secondary Outcome Measure Information:
Title
postoperative pain.
Description
Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
Time Frame
2 years
Title
Patient satisfaction (VAS-scale)
Description
Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
Time Frame
2 years
Title
Knee range of motion (degrees)
Description
Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Troelsen, M.D, Ph.D
Organizational Affiliation
Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Clinical and Stereoradiological Comparison of the Results After Primary Cemented Total Knee Arthroplasty Inserted With or Without the Use of a Tourniquet
We'll reach out to this number within 24 hrs