Post-Market Study of the 3DKnee™ System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00819481
Recruitment Status : Active, not recruiting
First Posted : January 9, 2009
Last Update Posted : February 7, 2017
Information provided by (Responsible Party):
Encore Medical, L.P.

January 8, 2009
January 9, 2009
February 7, 2017
February 2009
January 2014   (Final data collection date for primary outcome measure)
efficacy of total knee system [ Time Frame: 2 year ]
Same as current
Complete list of historical versions of study NCT00819481 on Archive Site
  • change in Knee Society Score [ Time Frame: 5 year ]
  • change in pain from pre-op to post-op [ Time Frame: 5 year ]
  • patient satisfaction [ Time Frame: 5 year ]
  • change in WOMAC Osteoarthritis Index from pre-surgery [ Time Frame: 5 year ]
  • change in Oxford Knee Score from pre-surgery [ Time Frame: 5 year ]
Same as current
Not Provided
Not Provided
Post-Market Study of the 3DKnee™ System
Post-Market Study of the 3DKnee™ System Protocol No. PS -- 700
The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.
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.
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients who are over 18 years of age and are candidates for a primary total knee replacement.
  • Degenerative Joint Disease
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Traumatic Arthritis
Device: 3DKnee™ System
Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.
Post Market Study
Intervention: Device: 3DKnee™ System
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
December 2017
January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
PS - 700
Not Provided
Not Provided
Encore Medical, L.P.
Encore Medical, L.P.
Not Provided
Principal Investigator: John W. McAllister, M.D. St. Peter's Bone and Joint Surgery
Principal Investigator: Barry J Waldman, M.D. OrthoMaryland
Encore Medical, L.P.
February 2017