Foundation Knee Study - Retrospective

Osteoarthritis Clinical Trial

Official title:

Post-Market Study of the Foundation Knee System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00764894
• Other study ID #: PS - 701
• Status: Terminated
• Phase: Phase 4
• First received: September 30, 2008
• Last updated: February 8, 2011
• Start date: October 2007
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis Secondary to Other Diseases
• Avascular Necrosis of the Femoral Condyles
• Inflammatory Tissue Disorders
• Osteoarthritis
• Post-traumatic Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	Hussamy Orthopedics	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Encore Medical, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The use and efficacy of the Encore Foundation Knee System		2 year	No

External Links

•   Sponsor Company home page