Long Term Foundation Knee Study

Total Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274546
• Other study ID #: PS-705
• Status: Completed
• Phase: N/A
• First received: January 10, 2011
• Last updated: August 6, 2012
• Start date: August 2010
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

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.

Locations

Country	Name	City	State
United States	Charleston Orthopaedic Assoc.	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Encore Medical, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Short Form - 36	SF-36 quality of life assessment questionnaire.	Single Visit	No
Secondary	Oxford Knee Score Assessment	Questionnaire	Single visit	No
Secondary	WOMAC Osteoarthritis Index	Questionnaire	Single visit	No
Secondary	Range of Motion	Physician measurements of the subjects range of motion on the operated knee.	Single visit	No
Secondary	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	No