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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: September 30, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Degenerative Joint Disease
Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Device: 3DKnee™ System
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Market Study of the 3DKnee™ System Protocol No. PS -- 700

Resource links provided by NLM:


Further study details as provided by Encore Medical, L.P.:

Primary Outcome Measures:
  • efficacy of total knee system [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: February 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
3DKnee
Post Market Study
Device: 3DKnee™ System
Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819481

Locations
United States, Arizona
Longo Orthopedics
Scottsdale, Arizona, United States, 85251
United States, California
Center for Excellence
Fresno, California, United States, 93710
United States, Maryland
OrthoMaryland
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.
Investigators
Principal Investigator: John W. McAllister, M.D. St. Peter's Bone and Joint Surgery
Principal Investigator: Barry J Waldman, M.D. OrthoMaryland
  More Information

Additional Information:
No publications provided

Responsible Party: Encore Medical, L.P.
ClinicalTrials.gov Identifier: NCT00819481     History of Changes
Other Study ID Numbers: PS - 700
Study First Received: January 8, 2009
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 24, 2014