At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 71 enrolled
Drug / intervention
3DKneedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The 3DKnee™ System: A Post-Market Study
In Brief
A Phase 4 clinical trial evaluating 3DKnee for Osteoarthritis and 4 related conditions. Completed, enrolled 71 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis, Varus Deformity, Avascular Necrosis
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedOct 2008
Primary CompletionOct 2010
TodayJul 2026
First PostedOct 2, 2008
Enrollment StartOct 1, 2006
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.8 years ago
Interventions
3DKneedevice
Subjects with knee osteoarthritis and willing to participate in the study