Trials / Terminated
TerminatedNCT01820676
iUni G2+ Prospective Study
A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2+ Unicompartmental Knee Resurfacing Device
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 28 (actual)
- Sponsor
- Restor3D · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to monitor long term clinical outcomes of the iUni G2+ unicompartmental knee replacement
Detailed description
The study subjects will be followed for 10 years post implant. The follow-up visit schedule will include visits at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post implant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2013-07-15
- Primary completion
- 2017-07-01
- Completion
- 2022-10-14
- First posted
- 2013-03-29
- Last updated
- 2023-10-25
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01820676. Inclusion in this directory is not an endorsement.