NL-OMON53155
Recruiting
Not Applicable
The Adler Genus Unicompartmental Knee Prosthesis Post-Marketing Surveillance Study - AGUKPPMSS
Adler Ortho S.r.l.0 sites50 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Unicondylar Knee replacement
- Sponsor
- Adler Ortho S.r.l.
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- A primary osteoarthritis of one compartment (Medial or Lateral).
- •\- Patients must be between the age of 18 and 80 at the time of consent
- •\- Listed for unicompartmental knee arthroplasty.
- •\- Patients who are willing to give informed written consent
- •\- Absence of any degenerative disease of a progressive nature (e.g.
- •Rheumatoid arthritis)
Exclusion Criteria
- •Progressive local or systemic infection
- •\- Muscular loss, neuromuscular disease or vascular deficiency of the
- •affected limb, making the operation unjustifiable
- •\- Severe instability secondary to advance destruction of chondral
- •structures or loss of integrity of the medial, lateral or either cruciate
- •\- Any patient who cannot or will not provide informed consent for
- •participation in the study
- •\- Those whose prospects for a recovery to independent mobility would
- •be compromised by known coexistent, medical problems
- •\- Patient whose BMI exceeds 45
Outcomes
Primary Outcomes
Not specified
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