Cemented vs. uncemented implantation of total knee endoprostheses using robotic surgery
- Conditions
- M17.1Other primary gonarthrosis
- Registration Number
- DRKS00023631
- Lead Sponsor
- Medizinische Hochschule Hannover
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 128
Male or female patients aged = 18 years.
- Primary gonarthrosis with indication for implantation of a KTEP
- UCLA score = 4 (activity score)
- Condition after previous bony operations or injuries in/on the knee joint (conversion osteotomies, intra-articular fractures)
- Condition after anterior and posterior cruciate ligament reconstruction
- BMI > 40
- Ligamentous instability of the collateral ligaments or the cruciate ligaments
- Condition after joint infection or existing systemic inflammatory disease
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the Oxford Knee Score (OKS) of the uncemented implant after 2 years, the non-inferiority of which will be shown compared to an already clinically established cemented procedure.
- Secondary Outcome Measures
Name Time Method - Recording of surgery-specific parameters (incision-suture time, blood loss, postoperative transfusion requirements)<br>- Recording of early complications, revision rate, implant survival<br>- Examination of the native radiological images during the course of the operation for early signs of loosening (radio lucent lines) and recording of the positioning and position of the prostheses in a group comparison.