Post-Market Study of the 3DKnee™ System
This study is ongoing, but not recruiting participants.
Sponsor:
Encore Medical, L.P.
Information provided by (Responsible Party):
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT00819481
First received: January 8, 2009
Last updated: January 4, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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. | Orthopedic Specialty Center |
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: | January 4, 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 Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013