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

November 8, 2022 updated by: Ross Leighton
The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized Total Knee Replacement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Total knee replacement candidates

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Combined Deformity <30 degrees
Device: Knee Implant
Total knee replacement with Genesis II posterior stabilized knee
Combined Deformity >30 degrees
Device: Knee Implant
Total knee replacement with Genesis II posterior stabilized knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Knee Society Clinical Rating
Time Frame: Pre-op, 6 months, 1 year, 2 years, 5 years
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
Pre-op, 6 months, 1 year, 2 years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ross Leighton

Collaborators

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Ross K Leighton, MD, FRCS(C), Capital Health, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

July 12, 2006

First Submitted That Met QC Criteria

July 12, 2006

First Posted (Estimate)

July 13, 2006

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDHA-RL-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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