Phase 4
N=71
The 3DKnee™ System: A Post-Market Study
Osteoarthritis · Rheumatoid Arthritis · Post Traumatic Arthritis · Varus Deformity · Avascular Necrosis
Bottom Line
View on ClinicalTrials.gov: NCT00764673 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Knee Society Score Evaluation — 82.9 Average Knee Rating Score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 3DKnee (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Encore Medical, L.P.
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Society Score Evaluation |
82.9 | — |
| PRIMARY Knee Society Function Score |
76.6 | — |
| PRIMARY Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component. |
— | — |
| PRIMARY Safety Assessment |
2; 18; 40 | — |
| SECONDARY Oxford Knee Score |
36.3 | — |
Summary
The purpose of this study is to evaluate the survivorship and efficacy of the Encore 3DKnee™ system in a group of patients who will receive the 3DKnee™ as a primary (first) orthopedic implant in the knee. Each knee will be designated as a separate subject and followed for a period of 2 years.
Eligibility Criteria
Inclusion Criteria
- This must be a primary knee replacement on this knee.
- 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
- Patient must be over 18 years of age
Exclusion Criteria
- 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
- Is younger than 18 years of age
Data sourced from ClinicalTrials.gov (NCT00764673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.