Post-Market Study of the 3DKnee™ System

Encore Medical

Status: Completed

Conditions: Traumatic Arthritis; Osteoarthritis; Rheumatoid Arthritis; Degenerative Joint Disease

Treatments: Device: 3DKnee™ System

Study type: Observational

Funder types: Industry

Identifiers

NCT00819481

PS - 700

Details and patient eligibility

About

The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.

Full description

Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery. The study will take place at multiple sites across the United States and be managed by the Encore Medical Clinical Affairs Department. The study will include only patients who meet the indications for use criteria for the 3DKnee™ System and who are candidates for primary knee arthroplasty.

Enrollment: 229 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• This must be a primary knee replacement on this knee.

• Patient is over 18 years of age or older

• Have knee joint disease related to one or more of the following

  • degenerative joint disease, including osteoarthritis or traumatic arthritis
  • Avascular necrosis of the femoral condyles
  • Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
  • Moderate valgus, varus, or flexion deformities
  • Rheumatoid arthritis

• 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

Exclusion criteria

• Is younger than 18 years of age
• If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
• Infection, or history of infection, acute or chronic, local or systemic
• Alcoholism or other addictions
• Muscular, neurological or vascular deficiencies which compromise the affected extremity
• Obesity
• Insufficient bone quality
• Loss of ligamentous structures
• High levels of physical activity
• Materials sensitivity
• Prisoner
• Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
• Patient is pregnant

Trial design

229 participants in 1 patient group

3DKnee

Description:

Post Market Study

Treatment:

Device: 3DKnee™ System