Mobile-bearing Unicondylar Knee Arthroplasty Clinical Trial
| NCT number | NCT01407042 |
| Other study ID # | PFJ-UKA-1 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | July 26, 2011 |
| Last updated | July 16, 2016 |
| Start date | September 2011 |
| Verified date | July 2016 |
| Source | Medical University Innsbruck |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ethikkommission |
| Study type | Observational |
Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from
unicompartmental knee osteoarthritis. Two different types of UKA design are available - both
with different pros and cons. The so-called 'mobile-bearing UKA' requires the removal of an
additional amount of cartilage and bone close to the implantat. It is unclear whether this
is of clinical relevance.
We speculate that the amount of cartilage/bone removal is related to the clinical outcome of
the UKA-surgery.
In patients receiving a mobile-bearing UKA that amount of cartilage/bone removal is measured
during the surgery. The clinical success of the procedure will be determined with certain
knee questionnaires (Kujala & KOOS)preoperatively, 3 months postoperatively, 6 months
postoperatively and 1 year postoperatively. Additionally, the so-called bone-remodelling
around that area of resected cartilage and bone will be measured (SPECT-CT) postoperatively.
The three variables (removed amount of cartilage/bone; clinical success with regard to the
questionnaires; bone remodelling) are then analyzed with statistical methods to find out
potential assoziations among them.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 99 Years |
| Eligibility |
Inclusion Criteria: - osteoarthritis or osteonecrosis in the medial or lateral tibiofemoral compartment Exclusion Criteria: - failed upper tibial osteotomy - insufficiency of the collateral or anterior cruciate ligaments - a fixed varus or valgus deformity (not passively correctable) above 15° - a flexion deformity greater than 15° - rheumatoid arthritis |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | Innsbruck Medical University | Innsbruck |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University Innsbruck |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Size of anterior femoral notch | Required cartilage / bone removal adjacent to the femoral implant | day 0 | No |
| Primary | Kujala Score changes | -1 days, 3 months, 6 months, 1 year | No | |
| Primary | KOOS questionnaire changes | -1 days, 3 months, 6 months, 1 year | No | |
| Primary | Radionuclide tracer uptake at the surgically created notch | 6 months | No |