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Post-Market Study of the 3DKnee™ System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT00819481
First received: January 8, 2009
Last updated: January 4, 2013
Last verified: January 2013
History of Changes

January 8, 2009
January 4, 2013
February 2009
December 2015   (final data collection date for primary outcome measure)
efficacy of total knee system [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00819481 on ClinicalTrials.gov Archive Site
  • change in Knee Society Score [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • change in pain from pre-op to post-op [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • patient satisfaction [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • change in WOMAC Osteoarthritis Index from pre-surgery [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • change in Oxford Knee Score from pre-surgery [ Time Frame: 5 year ] [ Designated as safety issue: No ]
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
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.
3DKnee
Post Market Study
Intervention: Device: 3DKnee™ System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
December 2017
December 2015   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00819481
PS - 700
No
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. Orthopedic Specialty Center
Encore Medical, L.P.
January 2013

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