Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

TerminatedOBSERVATIONAL
Enrollment

120

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

October 30, 2014

Study Completion Date

January 10, 2023

Conditions
Osteoarthritis
Interventions
DEVICE

iUni® Unicompartmental Knee Resurfacing Device

The iUni® Unicompartmental Resurfacing Device is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The patient-specific iUni is designed from a CT scan of an individual patient's knee using a design process which interactively maps the diseased area and defines the extent of misalignment present in the knee. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation

Trial Locations (8)

15146

Orthopedic Associates of Pittsburgh, Monroeville

32204

Heekin Clinic, Jacksonville

33462

JFK Medical Center, Atlantis

49015

Great Lakes Bone and Joint, Battle Creek

72205

Arkansas Specialty Orthopaedics & HipKneeArkansas Foundation for the Facility, Little Rock

77429

Advanced Orthopedics and Sports Medicine, Cypress

92253

S.T.A.R. Orthopaedics, La Quinta

93940

Center for the Knee and Shoulder, Monterey

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Restor3D

INDUSTRY