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

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE October 2, 2008
Results First Submitted Date  ICMJE November 19, 2010
Results First Posted Date  ICMJE March 2, 2011
Last Update Posted Date March 2, 2011
Study Start Date  ICMJE October 2006
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2011)
  • 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).
  • 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.
  • 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.
  • Safety Assessment [ Time Frame: 2-year ]
    Number of device related adverse events and device failures at the 2 year time frame.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
survivorship and efficacy of the Encore 3DKnee™ system [ Time Frame: 2-year ]
Change History Complete list of historical versions of study NCT00764673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2011)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The 3DKnee™ System: A Post-Market Study
Official Title  ICMJE The 3DKnee™ System: A Post-Market Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Post Traumatic Arthritis
  • Varus Deformity
  • Avascular Necrosis
Intervention  ICMJE Device: 3DKnee
Subjects with knee osteoarthritis and willing to participate in the study
Study Arms  ICMJE Primary
Post market study
Intervention: Device: 3DKnee
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2011)
71
Original Actual Enrollment  ICMJE
 (submitted: October 1, 2008)
88
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764673
Other Study ID Numbers  ICMJE PS - 703
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jane M. Jacob Ph.D., DJO Surgical
Study Sponsor  ICMJE Encore Medical, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John McAllister, M.D. St. Peter's Bone and Joint Surgery
PRS Account Encore Medical, L.P.
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP