An observational study in Osteoarthritis, sponsored by Restor3D. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Restor3D · Observational
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.
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 study subjects will be followed for 10 years post implant. The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis. The iUni is a patient-specific unicompartmental resurfacing device designed from the patient's unique anatomy using proprietary software which interprets data from the patient's CT scan. The patient matched implant design is then coupled with unique patient-matched disposable instrumentation designed using the same CT data and software. The follow-up visit schedule will include visits at 6 weeks, 6 months (optional), 1 year, 2 years, 5 years and 10 years post implant.The remaining follow-up data collected at years 3, 4, 6, 7, 8, and 9 may be collected via phone call/email and does not require a subject visit to the site.The study sites will be located in the United States.
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 120 is above the median of 100 across 803 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Restor3D is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients over 18 who have uni-compartmental osteoarthritis to be treated with a unilateral knee resurfacing procedure
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
iUni® Unicompartmental Knee Resurfacing Device
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
Knee Society Score
to assess knee pain and function
Time frame: 2 years
WOMAC Osteoarthritis Index
to assess knee pain and function
Time frame: 2 years
Knee Society Score and WOMAC at years 5 and 10 post-implantation
Patient reported outcomes measuring pain and function
Time frame: 10 years
Annual revision rates at years 1 through 10 post-implantation
Number of revision rates
Time frame: 10 years
Incidence of major procedure-related and device-related complications
rate of incidence of serious adverse events that are related to the device or the procedure
Time frame: 10 years
Length of tourniquet time in minutes
how long the tourniquet was on the patient in surgery
Time frame: 6 weeks
Length of hospital stay in hours
How long each patient was in the hospitals from admission to discharge
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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