iUni G2+ Prospective Study

NCT ID: NCT01820676

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-15
• Study Completion Date: 2022-10-14

Brief 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

Knee Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

iUni G2+

iUni G2+ in all patients

iUni G2+

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Restor3D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dinesh Nathwani, MD

Role: PRINCIPAL_INVESTIGATOR

The London Clinic

Locations

The London Clinic

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

12-004

Identifier Type: -

Identifier Source: org_study_id