Long Term Foundation Knee Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT01274546
First received: January 10, 2011
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the cruciate-retaining Foundation Knee system during or prior to the year 2000.


Condition Intervention
Total Knee Replacement
Device: cruciate-retaining Foundation Knee system

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Long-term, Multicenter Follow Up Study of the Cruciate-retaining Foundation Knee System

Further study details as provided by Encore Medical, L.P.:

Primary Outcome Measures:
  • Survivorship of the Device [ Time Frame: Single visit ] [ Designated as safety issue: No ]
    The subject meets the inclusion/exclusion of the study and has a Foundation Knee that has survived without revision to date.


Secondary Outcome Measures:
  • Knee Society Score Evaluation [ Time Frame: Single visit ] [ Designated as safety issue: No ]
    The knee society score includes both a subjective and a function score. The subjective score includes pain, stability and range of motion. The function score includes values for walking distance and climbing stairs.

  • Short Form - 36 [ Time Frame: Single Visit ] [ Designated as safety issue: No ]
    SF-36 quality of life assessment questionnaire.

  • Oxford Knee Score Assessment [ Time Frame: Single visit ] [ Designated as safety issue: No ]
    Questionnaire

  • WOMAC Osteoarthritis Index [ Time Frame: Single visit ] [ Designated as safety issue: No ]
    Questionnaire

  • Range of Motion [ Time Frame: Single visit ] [ Designated as safety issue: No ]
    Physician measurements of the subjects range of motion on the operated knee.

  • Radiographic failure [ Time Frame: Single visit ] [ Designated as safety issue: No ]
    Radiographic failure is defined as a shift in the position of the component >3mm or 3 degrees or a >2mm radiolucency completely around the prosthesis.


Enrollment: 43
Study Start Date: August 2010
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
"In Office"
These subjects will come into the office to perform the consenting process, and complete all evaluations required at the only visit in the study.
Device: cruciate-retaining Foundation Knee system
subjects who received the cruciate-retaining Foundation Knee system greater than or equal to 10 years ago and still maintain the original device in their knee.
"Telephone Arm"
These subjects will be consented over the phone and give a verbal consent to participate. They will complete all aspects of the study over the phone except for the knee society score evaluation and the x-ray.
Device: cruciate-retaining Foundation Knee system
subjects who received the cruciate-retaining Foundation Knee system greater than or equal to 10 years ago and still maintain the original device in their knee.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study will include only subjects who received the cruciate-retaining Foundation Knee System during or before the year 2000 and who voluntarily consent to take part in this study.

Criteria

Inclusion Criteria:

  • Subject must have received a cruciate-retaining Foundation Knee system during or prior to the year 2000.
  • Surgery must have been a primary knee replacement.
  • Subject must have received only one primary knee replacement per hospitalization
  • Subject must have had a primary diagnosis of osteoarthritis of the operative knee.
  • Subject is able and willing to sign the informed consent document

Exclusion Criteria:

  • Subject must not have had any previous knee implants (unicondylar or total joint replacements)
  • Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
  • Subject is a prisoner
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274546

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85251
United States, South Carolina
Charleston Orthopaedic Assoc.
Charleston, South Carolina, United States, 29414
Sponsors and Collaborators
Encore Medical, L.P.
Investigators
Principal Investigator: Richard J Friedman, M.D. Charleston Orthopedic Association
Principal Investigator: Joseph A Longo III, M.D.
  More Information

No publications provided

Responsible Party: Encore Medical, L.P.
ClinicalTrials.gov Identifier: NCT01274546     History of Changes
Other Study ID Numbers: PS-705
Study First Received: January 10, 2011
Last Updated: August 6, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 15, 2014