Foundation Knee Study - Retrospective

Terminated

• Conditions: Osteoarthritis; Post-traumatic Arthritis; Inflammatory Tissue Disorders; Avascular Necrosis of the Femoral Condyles; Arthritis Secondary to Other Diseases
• Interventions: Device: Foundation Knee

• Registration Number: NCT00764894
• Lead Sponsor: Encore Medical, L.P.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Status Verified: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2011-02-08
• Last Update Posted: 2011-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Foundation Knee	Foundation Knee	Retrospective data collection on 510(k) approved device

Primary Outcome Measures

Name	Time	Method
The use and efficacy of the Encore Foundation Knee System	2 year

Trial Locations

Locations (1)

Hussamy Orthopedics; 🇺🇸 Vero Beach, Florida, United States