The 3DKnee™ System: A Post-Market Study

Encore Medical

Status and phase: Completed; Phase 4

Conditions: Post Traumatic Arthritis; Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Varus Deformity

Treatments: Device: 3DKnee

Study type: Interventional

Funder types: Industry

Identifiers

NCT00764673

PS - 703

Details and patient eligibility

About

The purpose of this study is to evaluate the survivorship and efficacy of the Encore 3DKnee™ system in a group of patients who will receive the 3DKnee™ as a primary (first) orthopedic implant in the knee. Each knee will be designated as a separate subject and followed for a period of 2 years.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

• 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

• Patient must be over 18 years of age

Exclusion criteria

• 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
• Is younger than 18 years of age

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

Primary

Other group

Description:

Post market study

Treatment:

Device: 3DKnee