iUni G2+ Prospective Study

NCT01820676 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2023-10-25

No results posted yet for this study

Summary

This study is designed to monitor long term clinical outcomes of the iUni G2+ unicompartmental knee replacement

Conditions

Interventions

DEVICE

iUni G2+

The iUni G2+ Unicompartmental Resurfacing Device (iUni) 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 (Fitz).

Sponsors & Collaborators

  • Restor3D

    lead INDUSTRY

Principal Investigators

  • Dinesh Nathwani, MD · The London Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-15
Primary Completion
2017-07-01
Completion
2022-10-14

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01820676 on ClinicalTrials.gov