Post-Market Study of the 3DKnee™ System

Completed

• Conditions: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Degenerative Joint Disease
• Interventions: Device: 3DKnee™ System

• Registration Number: NCT00819481
• Lead Sponsor: Encore Medical, L.P.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Study Start: 2009-02
• Primary Completion: 2014-01
• Status Verified: 2017-02
• Study Completion: 2018-10
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3DKnee	3DKnee™ System	Post Market Study

Primary Outcome Measures

Name	Time	Method
efficacy of total knee system	2 year

Secondary Outcome Measures

Name	Time	Method
change in pain from pre-op to post-op	5 year
change in Oxford Knee Score from pre-surgery	5 year
change in Knee Society Score	5 year
patient satisfaction	5 year
change in WOMAC Osteoarthritis Index from pre-surgery	5 year

Trial Locations

Locations (8)

Center for Excellence; 🇺🇸 Fresno, California, United States

OrthoMaryland; 🇺🇸 Baltimore, Maryland, United States

Longo Orthopedics; 🇺🇸 Scottsdale, Arizona, United States

Leslie Orthopedics and Sports Medicine; 🇺🇸 Camdenton, Missouri, United States

Rimrock Orthopedics; 🇺🇸 Saint George, Utah, United States

St. Peter's Bone & Joint Surgery; 🇺🇸 Saint Peters, Missouri, United States

Texas Center for Joint Replacement; 🇺🇸 Plano, Texas, United States

Metro Orthopedics and Sports Therapy; 🇺🇸 Silver Spring, Maryland, United States