Mobile - Bearing Knee Study

Encore Medical

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis

Inflammatory Tissue Disorder

Secondary Arthritis

Avascular Necrosis

Post-traumatic Arthritis

Treatments

Device: Encore Mobile-Bearing Knee

Study type

Interventional

Funder types

Industry

Identifiers

Study 200

Details and patient eligibility

About

To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.

Enrollment

419 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Skeletal maturity
Less than 70 on preoperative Knee Society Score (Rating Score)
Sufficient bone stock, as judged by radiographs, to support primary knee implant
Patients with inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles
Patient is not pregnant
Primary total knee replacement
Sufficient collateral ligaments to support device, as judged by physician during stability testing (varus/valgus and flexion/extension)
Varus deformity <45 or valgus deformity <45 or fixed flexion deformity <90
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

Exclusion criteria

Skeletal immaturity
Greater than or equal to 70 on preoperative Knee Society Score (Rating Scale)
Previous knee surgery that has adversely affected bone stock or prior total knee replacement
Post patellectomy
Patient is pregnant
Insufficient collateral ligaments, as judged by the physician
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).
Varus deformity >45 or valgus deformity >45 or fixed flexion deformity >90.
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 the with 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).