Rheumatoid Arthritis Clinical Trial
Official title:
Post-Market Study of the 3DKnee™ System Protocol No. PS -- 700
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 |
Verified date | February 2017 |
Source | Encore Medical, L.P. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Encore Medical, L.P. |
United States,
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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