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The 3DKnee™ System: A Post-Market Study

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: NCT00764673
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : March 2, 2011
Last Update Posted : March 2, 2011
Information provided by:
Encore Medical, L.P.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Post Traumatic Arthritis Varus Deformity Avascular Necrosis Device: 3DKnee Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The 3DKnee™ System: A Post-Market Study
Study Start Date : October 2006
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Post market study
Device: 3DKnee
Subjects with knee osteoarthritis and willing to participate in the study

Primary Outcome Measures :
  1. Knee Society Score Evaluation [ Time Frame: 2 year ]
    The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).

  2. Knee Society Function Score [ Time Frame: 2-year ]
    The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success.

  3. Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component. [ Time Frame: 2-year ]
    Radiographic failure is defined as a complete radiolucent line > 2mm wide at the bone/cement interface or a >3 degree or >3 mm migration (shift) of the component.

  4. Safety Assessment [ Time Frame: 2-year ]
    Number of device related adverse events and device failures at the 2 year time frame.

Secondary Outcome Measures :
  1. Oxford Knee Score [ Time Frame: 2-year ]
    Questionnaire on the perceptions of patients about a total knee replacement. Score between 0 and 48 where: 0 to 19 may indicate severe knee arthritis, 20 to 29 may indicate moderate to severe knee arthritis, 30 to 39 may indicate mild to moderate knee arthritis and 40 to 48 may indicate satisfactory joint function.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00764673

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United States, Missouri
St. Peter's Bone & Joint Surgery
St. Peters, Missouri, United States, 63376
Sponsors and Collaborators
Encore Medical, L.P.
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Principal Investigator: John McAllister, M.D. St. Peter's Bone and Joint Surgery

Additional Information:
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Responsible Party: Jane M. Jacob Ph.D., DJO Surgical Identifier: NCT00764673    
Other Study ID Numbers: PS - 703
First Posted: October 2, 2008    Key Record Dates
Results First Posted: March 2, 2011
Last Update Posted: March 2, 2011
Last Verified: February 2011
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Pathologic Processes