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Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

NCT01117571 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-10-25

No results posted yet for this study

Summary

Study is prospective and multi-center. Study will include 100 to 200 patients across up to 20 sites.The study sites will be located in the United States.The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis.

Conditions

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

Sponsors & Collaborators

  • Restor3D

    lead INDUSTRY

Principal Investigators

  • C. Lowry Barnes, M.D · Hip Knee Arkansas Foundation

  • Marc Quartulli · Restor3D

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-10-30
Completion
2023-01-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01117571 on ClinicalTrials.gov