Status:
COMPLETED
Persona Versus NexGen
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Osteoarthritis Arthritis
Joint Diseases
Eligibility:
All Genders
21-90 years
Phase:
NA
Brief Summary
The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported excellent medium and long-term results in clinical studies and in implant registries all around the world. As a f...
Eligibility Criteria
Inclusion
- Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring primary knee arthroplasty
- Patient has been classified ASA 1 or 2 (for the kinematic analysis) (Meyer Saklad, 1941). As for the RSA study all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. Stratification is performed per diagnosis group (OA/RA).
Exclusion
- The patient is unable or unwilling to sign the Informed Consent specific to this study
- Insufficient Dutch or English language skills
- Patients indicated for revision arthroplasty
- Patient is (or might be) pregnant
- When there are less than five tibia-bone markers and less than five femur-bone markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria). In case only one of the bones has insufficient markers, the patient will be followed for the other bone.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02269254
Start Date
September 1 2014
End Date
June 1 2019
Last Update
February 11 2020
Active Locations (1)
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1
Leiden University Medical Center
Leiden, Netherlands, 2300RC