The Adler Genus Unicompartmental Knee Prosthesis Post-Marketing Surveillance Study

Recruiting

Conditions: Unicondylar Knee replacement
10005944

Registration Number: NL-OMON53155

Lead Sponsor: Adler Ortho S.r.l.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

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
ligament
- 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
- Any case not described in the inclusion criteria

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Implant survival rate keeping revision for any reason as an end point. Implant<br /><br>survival rate will be elaborated emplying the Kaplan-Meier statistical system.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cohort study<br /><br>1. Patients oxford Knee Score<br /><br>2. Knee Society Score<br /><br>3. EuroQol Score<br /><br>PROMS are being collected pre-op, 3 months, 6 months and annually after that.<br /><br>For clinical assesment it will be done at 1, 3, 5, 7 and 10 years<br /><br>post-operatively. Data will also be entered in the Dutch LROI system<br /><br>(landelijke register orthopedische implantaten)<br /><br>X-rays will be checked looking for prosthesis alignment and sign of loosening<br /><br>or wear.</p><br>