Foundation Knee Study - Retrospective

NCT ID: NCT00764894

Last Updated: 2011-02-09

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-02-28

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Foundation Knee

Retrospective data collection on 510(k) approved device

Foundation Knee

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Encore Medical, L.P.

INDUSTRY

Sponsor Role: lead

Responsible Party

DJO Surgical

Principal Investigators

Omar Hussamy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hussamy Orthopedics

Locations

Hussamy Orthopedics

Vero Beach, Florida, United States

Countries

United States

Related Links

http://www.djosurgical.com

Sponsor Company home page

Other Identifiers

PS - 701

Identifier Type: -

Identifier Source: org_study_id