iUni G2+ Prospective Study

NCT01820676 | Terminated

• 1 other identifier: 12-004
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• 2011 Knee Society Score

  1 Year

• KOOS Score

  1 Year

• Oxford Knee Score

  1 Year

Study Arms (1)

iUni G2+

iUni G2+ in all patients

Device: iUni G2+

Interventions

iUni G2+ 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).

iUni G2+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with knee osteoarthritis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Restor3D: lead

Study Sites (1)

The London Clinic

London, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Dinesh Nathwani, MD

  The London Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: March 29, 2013
• Study Start: July 15, 2013
• Primary Completion: July 1, 2017
• Study Completion: October 14, 2022
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

GB (1)