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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00351793
Recruitment Status : Active, not recruiting
First Posted : July 13, 2006
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
Nova Scotia Health Authority
Information provided by (Responsible Party):
Ross Leighton, Nova Scotia Health Authority

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

Condition or disease Intervention/treatment
Osteoarthritis Device: Knee Implant

Study Type : Observational
Actual Enrollment : 186 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement
Study Start Date : January 2003
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Knee Society Clinical Rating [ Time Frame: Pre-op, 6 months, 1 year, 2 years, 5 years ]
  2. Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Pre-op, 6 months, 1 year, 2 years, 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Total knee replacement candidates
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351793


Locations
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Ross Leighton
Nova Scotia Health Authority
Investigators
Principal Investigator: Ross K Leighton, MD, FRCS(C) Capital Health, Canada

Responsible Party: Ross Leighton, Orthopedic Surgeon, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT00351793     History of Changes
Other Study ID Numbers: CDHA-RL-004
First Posted: July 13, 2006    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases