Long Term Foundation Knee Study

Completed

• Conditions: Total Knee Replacement
• Interventions: Device: cruciate-retaining Foundation Knee system

• Registration Number: NCT01274546
• Lead Sponsor: Encore Medical, L.P.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-10
• Study First Posted: 2011-01-11
• Primary Completion: 2012-05
• Study Completion: 2012-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-06
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
"In Office"	cruciate-retaining Foundation Knee system	These subjects will come into the office to perform the consenting process, and complete all evaluations required at the only visit in the study.
"Telephone Arm"	cruciate-retaining Foundation Knee system	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charleston Orthopaedic Assoc.; 🇺🇸 Charleston, South Carolina, United States