Back to resultsSub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial
Primary Purpose
Tricompartmental Gonarthrosis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Sub-Vastus arthrotomy
Mid - Vastus arthrotomy
Sponsored by
About this trial
This is an interventional treatment trial for Tricompartmental Gonarthrosis
Eligibility Criteria
Inclusion Criteria:
- patients diagnosed with osteoarthrosis of the knee
- patients must be in good general health condition
Exclusion Criteria:
- patients with morbid obesity (BMI >45)
- patients with history of knee surgery, infection or inflammatory disease of the knee joint or large cartilage lesion
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sub - Vastus arthrotomy
Mid-Vastus arthrotomy
Arm Description
Sub-vastus arthrotomy
Mid-vastus arthrotomy
Outcomes
Primary Outcome Measures
VAS, KOOS and HSS scales
Rehabilitation time; time needed for 90° flexion of the knee joint
Secondary Outcome Measures
VAS, HSS, KOOS questionnaires
Amount and type of analgesic drugs used.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00925626
Brief Title
Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial
Official Title
Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial With One Year Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 2009 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized, single-blind trial in which one group of patients will be operated with a "Mid-Vastus approach" of the knee joint and the other group will undergo knee surgery with a "Sub-Vastus approach".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricompartmental Gonarthrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sub - Vastus arthrotomy
Arm Type
Experimental
Arm Description
Sub-vastus arthrotomy
Arm Title
Mid-Vastus arthrotomy
Arm Type
Active Comparator
Arm Description
Mid-vastus arthrotomy
Intervention Type
Procedure
Intervention Name(s)
Sub-Vastus arthrotomy
Intervention Description
Sub-vastus arthrotomy
Intervention Type
Procedure
Intervention Name(s)
Mid - Vastus arthrotomy
Intervention Description
Mid-vastus arthrotomy
Primary Outcome Measure Information:
Title
VAS, KOOS and HSS scales
Time Frame
at day 1, day 2, day 3, day 4 and day 5 post-operatively
Title
Rehabilitation time; time needed for 90° flexion of the knee joint
Time Frame
post-operatively
Secondary Outcome Measure Information:
Title
VAS, HSS, KOOS questionnaires
Time Frame
at 6 weeks, 3 months and 12 months after surgery.
Title
Amount and type of analgesic drugs used.
Time Frame
pre-operatively and post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients diagnosed with osteoarthrosis of the knee
patients must be in good general health condition
Exclusion Criteria:
patients with morbid obesity (BMI >45)
patients with history of knee surgery, infection or inflammatory disease of the knee joint or large cartilage lesion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Verdonk, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
website of the University Hospital Ghent
Learn more about this trial
Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial
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