CompletedNCT00351793Updated Nov 9, 2022

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

An observational study in Osteoarthritis, sponsored by Ross Leighton. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2022-11-09.

Sponsored by Ross Leighton · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 186
Sex: All

Study summary

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

Conditions studied

Osteoarthritis

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In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 186 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.

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Lead sponsor

Ross Leighton is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Total knee replacement candidates

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

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

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 186 participants (actual)

Groups and cohorts

Combined Deformity <30 degrees
Device: Knee Implant
Combined Deformity >30 degrees
Device: Knee Implant

Interventions

DeviceKnee Implant
Total knee replacement with Genesis II posterior stabilized knee

What researchers measure

Primary outcomes

Effectiveness and Safety
Will evaluate effectiveness and safety during a 5 year period via analysis of the Knee Society Score, revision status, and radiographic evaluation
Time frame: 5 years

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

Study locations

1 site

QEII Health Sciences Centre
Halifax, Nova Scotia B3H 3A7, Canada

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00351793
Lead sponsor: Ross Leighton
Collaborators: Nova Scotia Health Authority
Responsible party: Ross Leighton (Orthopedic Surgeon, Nova Scotia Health Authority) — Sponsor-investigator
First posted: Jul 13, 2006
Start date: Jan 2003
Primary completion: Dec 2018
Completion: Jul 2021
Last update: Nov 9, 2022

Study contacts

Ross K Leighton, MD, FRCS(C)

principal investigator · Capital Health, Canada

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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