Foundation Knee Study - Retrospective

This study has been terminated.
(Enrollment and data collection insufficient to continue study.)
Sponsor:
Information provided by:
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT00764894
First received: September 30, 2008
Last updated: February 8, 2011
Last verified: February 2011
  Purpose

The purpose of this study is to evaluate the use and efficacy of the Encore Foundation Knee System in a group of 200 patients for whom data has already been collected.


Condition Intervention Phase
Osteoarthritis
Post-traumatic Arthritis
Inflammatory Tissue Disorders
Arthritis Secondary to Other Diseases
Avascular Necrosis of the Femoral Condyles
Device: Foundation Knee
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post-Market Study of the Foundation Knee System

Resource links provided by NLM:


Further study details as provided by Encore Medical, L.P.:

Primary Outcome Measures:
  • The use and efficacy of the Encore Foundation Knee System [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Foundation Knee
Retrospective data collection on 510(k) approved device
Device: Foundation Knee
Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis who received a primary Foundation Knee replacement and is willing to participate in the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals who meet the indications for use of the Foundation Knee device AND who meet the inclusion/exclusion criteria

Criteria

Inclusion Criteria:

  • Have knee joint disease related to one or more of the following

    • osteoarthritis
    • post-traumatic arthritis
    • inflammatory tissue disorders
    • arthritis secondary to other diseases
    • Avascular necrosis of the femoral condyles;
  • Skeletal maturity
  • Less than 70 on the Knee Society Score (rating score)
  • Sufficient bone stock, as judged by radiographs, to support primary knee implant
  • Sufficient collateral ligaments to support the device, as judged by physician during stability testing (varus/valgus and flexion/extension) and less than 45 degree varus/valgus deformity and/or 90 degree flexion contracture
  • Patient is likely to be available for evaluation for the duration of the study
  • Able and willing to sign the informed consent and follow study procedures
  • Patient is not pregnant
  • No infection present
  • No known materials sensitivity

Exclusion Criteria:

  • Skeletal immaturity
  • Greater than or equal to 70 on preoperative Knee Society Score (Rating Score)
  • Post-patellectomy
  • Insufficient bone quality which may affect implant stability
  • Insufficient collateral ligaments, as judged by the physician. Greater than 45 degree varus/valgus deformity and/or 90 degree flexion contracture.
  • Neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as Parkinson's Disease, Multiple Sclerosis, previous stroke which affects lower extremity)
  • Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease)
  • Prisoners
  • Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity)
  • Patient is pregnant
  • Infection present
  • Materials sensitivity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764894

Locations
United States, Florida
Hussamy Orthopedics
Vero Beach, Florida, United States, 32960
Sponsors and Collaborators
Encore Medical, L.P.
Investigators
Principal Investigator: Omar Hussamy, M.D. Hussamy Orthopedics
  More Information

Additional Information:
No publications provided

Responsible Party: Jane M. Jacob Ph.D., DJO Surgical
ClinicalTrials.gov Identifier: NCT00764894     History of Changes
Other Study ID Numbers: PS - 701
Study First Received: September 30, 2008
Last Updated: February 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 30, 2014