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

niversitätsklinikum Heidelberg0 个研究点目标入组 306 人开始时间: 2020年4月30日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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)

•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)

发起方

niversitätsklinikum Heidelberg