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

September 30, 2008
February 8, 2011
October 2007
February 2011   (final data collection date for primary outcome measure)
The use and efficacy of the Encore Foundation Knee System [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00764894 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Foundation Knee Study - Retrospective
Post-Market Study of the Foundation Knee System

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Osteoarthritis
  • Post-traumatic Arthritis
  • Inflammatory Tissue Disorders
  • Arthritis Secondary to Other Diseases
  • Avascular Necrosis of the Femoral Condyles
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.
Foundation Knee
Retrospective data collection on 510(k) approved device
Intervention: Device: Foundation Knee
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00764894
PS - 701
No
Jane M. Jacob Ph.D., DJO Surgical
Encore Medical, L.P.
Not Provided
Principal Investigator: Omar Hussamy, M.D. Hussamy Orthopedics
Encore Medical, L.P.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP