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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00819481
Other study ID # PS - 700
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2009
Est. completion date October 2018

Study information

Verified date February 2017
Source Encore Medical, L.P.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 229
Est. completion date October 2018
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
3DKnee™ System
Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.

Locations

Country Name City State
United States OrthoMaryland Baltimore Maryland
United States Leslie Orthopedics and Sports Medicine Camdenton Missouri
United States Center for Excellence Fresno California
United States Texas Center for Joint Replacement Plano Texas
United States Rimrock Orthopedics Saint George Utah
United States St. Peter's Bone & Joint Surgery Saint Peters Missouri
United States Longo Orthopedics Scottsdale Arizona
United States Metro Orthopedics and Sports Therapy Silver Spring Maryland

Sponsors (1)

Lead Sponsor Collaborator
Encore Medical, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary efficacy of total knee system 2 year
Secondary change in Knee Society Score 5 year
Secondary change in pain from pre-op to post-op 5 year
Secondary patient satisfaction 5 year
Secondary change in WOMAC Osteoarthritis Index from pre-surgery 5 year
Secondary change in Oxford Knee Score from pre-surgery 5 year
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