iUni G2+ Prospective Study

October 23, 2023 updated by: Restor3D

A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2+ Unicompartmental Knee Resurfacing Device

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with knee osteoarthritis

Description

Inclusion Criteria:

  • Clinical condition included in the approved Indications For Use
  • Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment
  • Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
  • > 18 years of age

Exclusion Criteria:

  • Simultaneous bilateral procedure required
  • BMI > 35
  • Treatment for cancer within the past 5 years, with the exception of skin cancer
  • Poorly controlled diabetes
  • Neuromuscular conditions which prevent patient from participating in study activities
  • Active local or systemic infection
  • Immunocompromised
  • Fibromyalgia or other general body pain related condition
  • Advanced tricompartmental osteoarthritis
  • Symptomatic patellofemoral disease
  • Rheumatoid arthritis or other forms of inflammatory joint disease (excluding Gout unless it is in the treated knee or limiting overall function)
  • Loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified. Osteoporosis is defined by more than -2.5 standard deviations from the T score as measured on a Dual Energy X-Ray Absortiometry Scan (DEXA) within 2 years of surgery.
  • Advanced loss of osteochondral structure on the affected femoral condyle
  • Compromised ACL, PCL or collateral ligament
  • Severe (>15º) fixed valgus or varus deformity
  • Extension deficit > 15 º
  • Prior history of failed implant surgery of the joint to be treated
  • Unwilling or unable to comply with study requirements
  • Participation in another clinical study which would confound results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
iUni G2+
iUni G2+ in all patients
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2011 Knee Society Score
Time Frame: 1 Year
1 Year
KOOS Score
Time Frame: 1 Year
1 Year
Oxford Knee Score
Time Frame: 1 Year
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Restor3D

Investigators

  • Principal Investigator: Dinesh Nathwani, MD, The London Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2013

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

October 14, 2022

Study Registration Dates

First Submitted

March 26, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimated)

March 29, 2013

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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