Post-Market Study of the 3DKnee™ System - Full Text View

Sponsored by:	Encore Medical, L.P.
Information provided by:	Encore Medical, L.P.
ClinicalTrials.gov Identifier:	NCT00819481

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 IV

MedlinePlus related topics: Joint Disorders Knee Replacement Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Post-Market Study of the 3DKnee™ System Protocol No. PS -- 700

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:	March 2009
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 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

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

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

Locations

United States, California
Center for Excellence
Fresno, California, United States, 93710
United States, Maryland
Capitol Sports Medicine and Orthopaedic Center
Silver Spring, Maryland, United States, 20910
United States, Missouri
St. Peter's Bone & Joint Surgery
St. Peters, Missouri, United States, 63376
Leslie Orthopedics and Sports Medicine
Camdenton, Missouri, United States, 65020
United States, New York
Hospital for Special Surgery Dept of Orthopedics
New York, New York, United States, 10021

Sponsors and Collaborators

Encore Medical, L.P.

Investigators

Principal Investigator:	Stephen Fealy, M.D.	Hospital for Special Surgery
Principal Investigator:	Christopher Leslie, M.D.	Leslie Orthopedics and Sports Medicine
Principal Investigator:	D. Kevin Lester, M.D.	Center for Excellence
Principal Investigator:	John W. McAllister, M.D.	St. Peter's Bone and Joint Surgery
Principal Investigator:	Phillip Omohundro, M.D.	Capitol Sports Medicine and Orthopaedic Center

More Information

Sponsor company home page This link exits the ClinicalTrials.gov site

Responsible Party:	Encore Medical L.P. dba DJO Surgical ( Jane M. Jacob, Ph.D. )
Study ID Numbers:	PS - 700
Study First Received:	January 8, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819481
Health Authority:	United States: Institutional Review Board

Keywords provided by Encore Medical, L.P.:

Total knee replacement

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Osteoarthritis
Arthritis

Joint Diseases
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009