Status:
COMPLETED
Matched Pair Study - Kinematic Vs Mechanical Alignment
Lead Sponsor:
Medacta International SA
Conditions:
Osteoarthritis, Knee
Joint Disease
Eligibility:
All Genders
Brief Summary
The aim of this study is to evaluate postoperative knee function after total knee arthroplasty performed according to the anatomical alignment and compare these results to those of a matched historica...
Detailed Description
The 25 patients, of the Kinematic group, are prospectively enrolled. While, the data of patients of the Mechanical group, are retrospectively collected from an historical collection.
Eligibility Criteria
Inclusion
- Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use).
- Patients necessitating primary Total Knee Replacement
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
Exclusion
- Those with one or more medical conditions identified as a contraindication defined by the labeling on Medacta implants used in this study.
- Previous osteotomy around the knee
- Ligament instability likely to require higher level of constraint
- Previous infection or inflammatory disease
- Extraarticular deformities for which a femoral intramedullary guide rod can't be inserted into the canal and use of Computer Assisted Orthopaedic Surgery (CAOS) or Patient Specific Instrumentation (PSI) is required.
Key Trial Info
Start Date :
January 2 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 18 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03446391
Start Date
January 2 2018
End Date
May 18 2019
Last Update
December 16 2024
Active Locations (1)
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1
St. Vinzenz Krankenhaus Brakel
Brakel, North Rhine-Westphalia, Germany, 33034