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Completed

NCT Number: NCT01274546

Long Term Foundation Knee Study

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.

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Key information

Conditions

Total Knee Replacement

Sex eligibility

All sexes

Study type

Observational

Primary location

Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Survivorship of the Device

    Time frame: Single visit

    The subject meets the inclusion/exclusion of the study and has a Foundation Knee that has survived without revision to date.

Secondary outcomes

  1. Knee Society Score Evaluation

    Time frame: 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.

  2. Short Form - 36

    Time frame: Single Visit

    SF-36 quality of life assessment questionnaire.

  3. Oxford Knee Score Assessment

    Time frame: Single visit

    Questionnaire

  4. WOMAC Osteoarthritis Index

    Time frame: Single visit

    Questionnaire

  5. Range of Motion

    Time frame: Single visit

    Physician measurements of the subjects range of motion on the operated knee.

  6. Radiographic failure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Encore Medical, L.P.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 11, 2011
Registry last updated
Aug 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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