A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement

Ross Leighton

Status: Completed

Conditions: Osteoarthritis

Treatments: Device: Knee Implant

Study type: Observational

Funder types: Other

Identifiers

NCT00351793

CDHA-RL-004

Details and patient eligibility

About

The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized Total Knee Replacement.

Enrollment: 186 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• A combined deformity of <30 degrees = group 1
• A combined deformity of >30 degrees = group 2
• Patient is willing to consent to participate in the study
• Patient is available for follow-up through at least 2 years but preferably 5 years
• Patient has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk
• Patients who are fluent in English and are able to understand their role in a clinical trial

Exclusion criteria

• Active, local infection or systemic infection
• Fibromyalgia patients
• Patients whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol and or are reasonably unlikely to be compliant with the prescribed routine and the follow-up evaluation schedule

Trial design

186 participants in 2 patient groups

Combined Deformity <30 degrees

Treatment:

Device: Knee Implant

Combined Deformity >30 degrees

Treatment:

Device: Knee Implant