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

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

Completed

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Knee Implant

Device

Total knee replacement with Genesis II posterior stabilized knee

Primary outcomes

Effectiveness and Safety

Time frame: 5 years

Will evaluate effectiveness and safety during a 5 year period via analysis of the Knee Society Score, revision status, and radiographic evaluation

Secondary outcomes

Knee Society Clinical Rating

Time frame: Pre-op, 6 months, 1 year, 2 years, 5 years
Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC)

Time frame: Pre-op, 6 months, 1 year, 2 years, 5 years

Sponsors and collaborators

Lead sponsor

Ross Leighton

Other

Collaborators

Nova Scotia Health Authority

Registry information

Important dates

Study start: 2003
Primary completion: 2018
Study completion: 2021
First posted: Jul 13, 2006
Registry last updated: Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed