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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Capital District Health Authority, Canada.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00351793
First received: July 12, 2006
Last updated: February 15, 2012
Last verified: July 2006
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoarthritis
 Device: Knee Implant
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Effectiveness and Safety [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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:
  • Knee Society Clinical Rating [ Time Frame: Pre-op, 6 months, 1 year, 2 years, 5 years ] [ Designated as safety issue: No ]
  • SF 12 Survey [ Time Frame: Pre-op, 6 weeks, 6 months, 1 year, 2 years, 5 years ] [ Designated as safety issue: No ]
  • WOMAC Survey [ Time Frame: Pre-op, 6 months, 1 year, 2 years, 5 years ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: January 2003
Estimated Study Completion Date: January 2013
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351793

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

No publications provided

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00351793     History of Changes
Other Study ID Numbers: CDHA-RL-004
Study First Received: July 12, 2006
Last Updated: February 15, 2012
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on June 18, 2013