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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.
ClinicalTrials.gov 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.

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

Condition or disease Intervention/treatment
Degenerative Joint Disease Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Device: 3DKnee™ System

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 Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Market Study of the 3DKnee™ System Protocol No. PS -- 700
Study Start Date : February 2009
Primary Completion Date : January 2014
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Post Market Study
Device: 3DKnee™ System
Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.

Primary Outcome Measures :
  1. efficacy of total knee system [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. change in Knee Society Score [ Time Frame: 5 year ]
  2. change in pain from pre-op to post-op [ Time Frame: 5 year ]
  3. patient satisfaction [ Time Frame: 5 year ]
  4. change in WOMAC Osteoarthritis Index from pre-surgery [ Time Frame: 5 year ]
  5. change in Oxford Knee Score from pre-surgery [ Time Frame: 5 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are over 18 years of age and are candidates for a primary total knee replacement.

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

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 ClinicalTrials.gov identifier (NCT number): NCT00819481

United States, Arizona
Longo Orthopedics
Scottsdale, Arizona, United States, 85251
United States, California
Center for Excellence
Fresno, California, United States, 93710
United States, Maryland
Baltimore, Maryland, United States, 21209
Metro Orthopedics and Sports Therapy
Silver Spring, Maryland, United States, 20910
United States, Missouri
Leslie Orthopedics and Sports Medicine
Camdenton, Missouri, United States, 65020
St. Peter's Bone & Joint Surgery
St. Peters, Missouri, United States, 63376
United States, Texas
Texas Center for Joint Replacement
Plano, Texas, United States, 75093
United States, Utah
Rimrock Orthopedics
St. George, Utah, United States, 84790
Sponsors and Collaborators
Encore Medical, L.P.
Principal Investigator: John W. McAllister, M.D. St. Peter's Bone and Joint Surgery
Principal Investigator: Barry J Waldman, M.D. OrthoMaryland

Additional Information:
Responsible Party: Encore Medical, L.P.
ClinicalTrials.gov Identifier: NCT00819481     History of Changes
Other Study ID Numbers: PS - 700
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

Keywords provided by Encore Medical, L.P.:
Total knee replacement

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases