M17.9
Conditions
Interventions
Group 1: cementless UKR
Group 2: cemented UKR
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -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
| Measure | Time frame |
|---|---|
| -American Knee Society Score (AKSS): measures rangeof motion and function of the knee - UCLA Activity Score: measurement of patient activity level in arthroplasty patients with mid/lower level activity - Knee Injury and Osteoarthritis Outcome Score (KOOS) - Forgotten Knee Score (FJS-12): assessment of joint awareness in knee patients - Visual Analog Pain Score (VAS): measurement of patient subjective pain levels - Satisfaction with the implant - Radiographic features including signs of implant loosening and radiolucency lines - Duration of surgery and blood loss - Length of hospital stay - Complications (including periprosthetic fracture) - Re-operation rate Change in bone mineral density (via DXA) around the femoral and tibial components preoperatively and two years after surgery | — |
Countries
Austria, Germany
Contacts
Public ContactEmanuela Dabbeni
Klinik für Orthopädie und Unfallchirurgie Universität Heidelberg
Outcome results
None listed