Cemented versus Uncemented Partial Knee Arthroplasty Trial – The CUPKAT Trial – A prospective, randomized controlled trial

Recruitment & Eligibility

Status: Recruiting withdrawn before recruiting started

Sex: All

Target Recruitment: 306

Inclusion Criteria

indication for medial unicompartmental knee arthroplasty according to the Oxford UKA criteria (J. W. Goodfellow et al., 1988)
- Anteromedial osteoarthritis with full thickness cartilage loss of the medial compartment
- Well preserved lateral compartment on valgus stress xray images
- Passively correctable intra-articular varus deformity
- Age 18 years or older
- Ability of subject to understand character and individual consequences of the clinical Trial
Signed informed consent (must be available before enrollment in the trial)

Exclusion Criteria

Patients found to be unsuitable for Oxford UKA before or during surgery
- Preoperative extension limitation greater than 15 degrees and/or maximal flexion of less than 100 degrees
- severe lateral patellar facet OA with bone loss and grooving
- Functionally insufficient anterior cruciate ligament
- History of hypersensitivity reaction to metal implants made of cobalt-chromium-alloys
- All forms of inflammatory arthritis (such as rheumatoid arthritis)
- Patients with previous PTO (proximal tibial osteotomy)
- Patients with intraarticular fracture and tibial condyle fracture sequelae
- History of septic arthritis
- Senile dementia
- Insufficient knowledge of the German language (written and spoken)
- Participation in other clinical trials or observation period of competing trials, respectively.
- Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) (Inclusion of such patients will have different regulations implications)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Comparison of clinical and functional results 2 years after cemented versus uncemented unicompartmental knee arthroplasty with the Oxford Knee Score (OKS) being the primary Outcome parameter

Secondary Outcome Measures

Name	Time	Method
-American Knee Society Score (AKSS): measures rangeof motion and function of the knee<br>- UCLA Activity Score: measurement of patient activity level in arthroplasty patients with mid/lower level activity<br>- Knee Injury and Osteoarthritis Outcome Score (KOOS)<br>- Forgotten Knee Score (FJS-12): assessment of joint awareness in knee patients<br>- Visual Analog Pain Score (VAS): measurement of patient subjective pain levels<br>- Satisfaction with the implant<br>- Radiographic features including signs of implant loosening and radiolucency lines<br>- Duration of surgery and blood loss<br>- Length of hospital stay<br>- Complications (including periprosthetic fracture)<br>- Re-operation rate<br>Change in bone mineral density (via DXA) around the femoral and tibial components preoperatively and two years after surgery