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Cemented vs. uncemented implantation of total knee endoprostheses using robotic surgery

Not Applicable
Recruiting
Conditions
M17.1
Other 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
Inclusion Criteria

Male or female patients aged = 18 years.
- Primary gonarthrosis with indication for implantation of a KTEP
- UCLA score = 4 (activity score)

Exclusion Criteria

- 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
NameTimeMethod
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
NameTimeMethod
- 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.
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