Tricompartmental Gonarthrosis Clinical Trial
Official title:
Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial With One Year Follow-up
| NCT number | NCT00925626 |
| Other study ID # | 2009/256 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 2009 |
| Est. completion date | August 2015 |
| Verified date | July 2021 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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".
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 45 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Ghent | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | VAS, KOOS and HSS scales | at day 1, day 2, day 3, day 4 and day 5 post-operatively | ||
| Primary | Rehabilitation time; time needed for 90° flexion of the knee joint | post-operatively | ||
| Secondary | VAS, HSS, KOOS questionnaires | at 6 weeks, 3 months and 12 months after surgery. | ||
| Secondary | Amount and type of analgesic drugs used. | pre-operatively and post-operatively |