Long Term Foundation Knee Study

NCT01274546 | Completed

• 1 other identifier: PS-705
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Knee Society Score Evaluation

  Single visit

• Short Form - 36

  Single Visit

• Oxford Knee Score Assessment

  Single visit

• WOMAC Osteoarthritis Index

  Single visit

• Range of Motion

  Single visit

Study Arms (2)

"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

"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

Interventions

cruciate-retaining Foundation Knee system DEVICE

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.

"In Office"; "Telephone Arm"

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Encore Medical, L.P.: lead

Study Sites (2)

Unknown Facility

Scottsdale, Arizona, 85251, United States

Location

Charleston Orthopaedic Assoc.

Charleston, South Carolina, 29414, United States

Location

Study Officials

• Richard J Friedman, M.D.

  Charleston Orthopedic Association

  PRINCIPAL INVESTIGATOR

• Joseph A Longo III, M.D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 11, 2011
• Study Start: August 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 7, 2012

Record last verified: 2012-08

Locations

US (2)