Phase 4 Completed N=71 Treatment

The 3DKnee™ System: A Post-Market Study

Osteoarthritis · Rheumatoid Arthritis · Post Traumatic Arthritis · Varus Deformity

Source: ClinicalTrials.gov NCT00764673 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2011

Primary outcomePrimary: Knee Society Score Evaluation — 82.9 Average Knee Rating Score

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.