Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

Stopped early

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT01117571

Run by

Restor3D

People needed

120

Starts

2010-04-01

Expected to finish

2023-01-10

Last updated by the study team

2023-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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
• 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

Where it is running

• Arkansas Specialty Orthopaedics & HipKneeArkansas Foundation for the Facility — Little Rock, Arkansas, United States
• S.T.A.R. Orthopaedics — La Quinta, California, United States
• Center for the Knee and Shoulder — Monterey, California, United States
• JFK Medical Center — Atlantis, Florida, United States
• Heekin Clinic — Jacksonville, Florida, United States
• Great Lakes Bone and Joint — Battle Creek, Michigan, United States
• Orthopedic Associates of Pittsburgh — Monroeville, Pennsylvania, United States
• Advanced Orthopedics and Sports Medicine — Cypress, Texas, United States

Full record on ClinicalTrials.gov

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