A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System

Stopped early

Conditions studied: Osteoarthritis of the Knee

In brief

This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.

Key facts

Study ID

NCT01820650

Run by

Restor3D

People needed

359

Starts

2013-02-01

Expected to finish

2023-10-01

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 for the iTotal® CR
• Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
• 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 > 40
• Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
• 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
• Rheumatoid arthritis or other forms of inflammatory joint disease
• Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified
• Diagnosed with or receiving treatment for Osteoporosis
• Other physical disability affecting the hips, spine, or contralateral knee.
• Severe instability due to advanced loss of osteochondral structure
• Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
• Compromised PCL or collateral ligament
• Severe fixed valgus or varus deformity of >15º
• Extensor lag > 15 º
• Fixed flexion contracture ≥ 15 º
• Unwilling or unable to comply with study requirements
• Participation in another clinical study which would confound results
• Allergy to any of the implant materials

Where it is running

• JFK Medical Center — Atlantis, Florida, United States
• EMMC - Orthopaedic Surgery of Maine — Bangor, Maine, United States
• Great Lakes Bone and Joint — Battle Creek, Michigan, United States
• Orthopaedic Instatute of Henderson — Henderson, Nevada, United States
• Desert Orthopedic Center — Las Vegas, Nevada, United States
• Tennessee Orthopaedic Alliance — Nashville, Tennessee, United States
• Advanced Orthopedics and Sports Medicine — Cypress, Texas, United States
• Joint Replacement Associates — Houston, Texas, United States
• Mansfield Orthopaedics — Morrisville, Vermont, United States

Full record on ClinicalTrials.gov

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