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The Adler Genus Unicompartmental Knee Prosthesis post-marketing surveillance study

The clinical perfomances of the Genus Unicompartmental Knee Prosthesis manufactured by Adler Ortho srl will be evaluated by a multicentre prospective clinical surveillance study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14119313
Enrollment
350
Registered
2015-03-11
Start date
2015-01-22
Completion date
Unknown
Last updated
2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the knee treated with knee arthroplasty (knee replacement surgery) Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]

Interventions

Each patient will be submitted to the following set of investigation tools: Pre-op: patient’s demographic and radiological review
baseline questionnaire - EuroQol, Oxford Knee and Knee Society scores. Peri-op: operation details including peri-operative and early post-operative complications (complications that oc

Sponsors

Adler Ortho srl
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. A primary osteoarthritis of one compartment (medial or lateral) 2. Patients must be between the age of 18 and 80 at the time of consent 3. Listed for unicompartmental knee arthroplasty 4. Patients who are willing to give informed written consent 5. Absence of any degenerative disease of a progressive nature (e.g. rheumatoid arthritis)

Exclusion criteria

Exclusion criteria: 1. Progressive local or systemic infection 2. Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable 3. Severe instability secondary to advanced destruction of chondral structures or loss of integrity of the medial, lateral or either cruciate ligament 4. Any patient who cannot or will not provide informed consent for participation in the study 5. Those whose prospects for a recovery to independent mobility would be compromised by known coexistent medical problems 6. Patient whose BMI exceeds 45 7. Any case not described in the inclusion criteria

Design outcomes

Primary

MeasureTime frame
Implant survival rate keeping revision for any reason of any prosthetic component as an end point. Implant survival rate will be elaborated employing the Kapan-Meier statistical system.

Secondary

MeasureTime frame
1. Patients Oxford Knee score 2. Knee Society Score 3. EuroQol score PROMs are being collected pre-op, 3 months, 6 months and annually after that. For clinical assessment it will be done at 1, 3, 5, 7 and 10 years post-operatively

Countries

France, United Kingdom

Contacts

Public ContactCarlo Dottino
cdottino@adlerortho.com+39 02 615437201

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026