iUni G2+ Prospective Study
NCT01820676 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 28
Last updated 2023-10-25
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
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