Post-Market Study of the 3DKnee™ System
1 other identifier
observational
229
1 country
8
Brief Summary
The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2009
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2009
CompletedFirst Posted
Study publicly available on registry
January 9, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedMarch 16, 2021
February 1, 2017
4.9 years
January 8, 2009
March 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
efficacy of total knee system
2 year
Secondary Outcomes (5)
change in Knee Society Score
5 year
change in pain from pre-op to post-op
5 year
patient satisfaction
5 year
change in WOMAC Osteoarthritis Index from pre-surgery
5 year
change in Oxford Knee Score from pre-surgery
5 year
Study Arms (1)
3DKnee
Post Market Study
Interventions
Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.
Eligibility Criteria
Patients who are over 18 years of age and are candidates for a primary total knee replacement.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Longo Orthopedics
Scottsdale, Arizona, 85251, United States
Center for Excellence
Fresno, California, 93710, United States
OrthoMaryland
Baltimore, Maryland, 21209, United States
Metro Orthopedics and Sports Therapy
Silver Spring, Maryland, 20910, United States
Leslie Orthopedics and Sports Medicine
Camdenton, Missouri, 65020, United States
St. Peter's Bone & Joint Surgery
City of Saint Peters, Missouri, 63376, United States
Texas Center for Joint Replacement
Plano, Texas, 75093, United States
Rimrock Orthopedics
St. George, Utah, 84790, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John W. McAllister, M.D.
St. Peter's Bone and Joint Surgery
- PRINCIPAL INVESTIGATOR
Barry J Waldman, M.D.
OrthoMaryland
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2009
First Posted
January 9, 2009
Study Start
February 1, 2009
Primary Completion
January 1, 2014
Study Completion
October 1, 2018
Last Updated
March 16, 2021
Record last verified: 2017-02