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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00351793
First received: July 12, 2006
Last updated: March 6, 2014
Last verified: March 2014

July 12, 2006
March 6, 2014
January 2003
Not Provided
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
Not Provided
Complete list of historical versions of study NCT00351793 on ClinicalTrials.gov Archive Site
  • Knee Society Clinical Rating [ Time Frame: Pre-op, 6 months, 1 year, 2 years, 5 years ] [ Designated as safety issue: No ]
  • Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Pre-op, 6 months, 1 year, 2 years, 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Total knee replacement candidates

Osteoarthritis
Device: Knee Implant
Total knee replacement with Genesis II posterior stabilized knee
  • Combined Deformity <30 degrees
    Intervention: Device: Knee Implant
  • Combined Deformity >30 degrees
    Intervention: Device: Knee Implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
186
January 2015
Not Provided

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00351793
CDHA-RL-004
No
Capital District Health Authority, Canada
Capital District Health Authority, Canada
Not Provided
Principal Investigator: Ross K Leighton, MD, FRCS(C) Capital Health, Canada
Capital District Health Authority, Canada
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP