Study Stopped
Enrollment and data collection insufficient to continue study.
Foundation Knee Study - Retrospective
Post-Market Study of the Foundation Knee System
1 other identifier
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFebruary 9, 2011
February 1, 2011
3.3 years
September 30, 2008
February 8, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The use and efficacy of the Encore Foundation Knee System
2 year
Study Arms (1)
Foundation Knee
Retrospective data collection on 510(k) approved device
Interventions
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 Criteria
Individuals who meet the indications for use of the Foundation Knee device AND who meet the inclusion/exclusion criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hussamy Orthopedics
Vero Beach, Florida, 32960, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omar Hussamy, M.D.
Hussamy Orthopedics
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2008
First Posted
October 2, 2008
Study Start
October 1, 2007
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
February 9, 2011
Record last verified: 2011-02