iUni G2+ Prospective Study

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01820676
• Other study ID #: 12-004
• Status: Terminated
• Start date: July 15, 2013
• Est. completion date: October 14, 2022

Study information

• Verified date: October 2023
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: October 14, 2022
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	The London Clinic	London

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2011 Knee Society Score		1 Year
Primary	KOOS Score		1 Year
Primary	Oxford Knee Score		1 Year