Long Term Foundation Knee Study

A Long-term, Multicenter Follow Up Study of the Cruciate-retaining Foundation Knee System

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Replacement
• Intervention / Treatment: Device: cruciate-retaining Foundation Knee system

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Orthopaedic Assoc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
"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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship of the Device	The subject meets the inclusion/exclusion of the study and has a Foundation Knee that has survived without revision to date.	Single visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score Evaluation	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.	Single visit
Short Form - 36	SF-36 quality of life assessment questionnaire.	Single Visit
Oxford Knee Score Assessment	Questionnaire	Single visit
WOMAC Osteoarthritis Index	Questionnaire	Single visit
Range of Motion	Physician measurements of the subjects range of motion on the operated knee.	Single visit
Radiographic failure	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.	Single visit

Collaborators and Investigators

• Sponsor: Encore Medical, L.P.
• Investigators: Principal Investigator: Richard J Friedman, M.D., Charleston Orthopedic Association; Principal Investigator: Joseph A Longo III, M.D.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: January 10, 2011
• First Posted (Estimate): January 11, 2011

Study Record Updates

• Last Update Posted (Estimate): August 7, 2012
• Last Update Submitted That Met QC Criteria: August 6, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: PS-705