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

Terminated

• Conditions: Osteoarthritis of the Knee

• Registration Number: NCT01820650
• Lead Sponsor: Restor3D

Brief Summary

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

Detailed Description

If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-29
• Primary Completion: 2017-03
• Status Verified: 2023-10
• Study Completion: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 359

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2011 Knee Society Score	1 Year

Trial Locations

Locations (9)

EMMC - Orthopaedic Surgery of Maine; 🇺🇸 Bangor, Maine, United States

Tennessee Orthopaedic Alliance; 🇺🇸 Nashville, Tennessee, United States

Desert Orthopedic Center; 🇺🇸 Las Vegas, Nevada, United States

JFK Medical Center; 🇺🇸 Atlantis, Florida, United States

Orthopaedic Instatute of Henderson; 🇺🇸 Henderson, Nevada, United States

Great Lakes Bone and Joint; 🇺🇸 Battle Creek, Michigan, United States

Advanced Orthopedics and Sports Medicine; 🇺🇸 Cypress, Texas, United States

Joint Replacement Associates; 🇺🇸 Houston, Texas, United States

Mansfield Orthopaedics; 🇺🇸 Morrisville, Vermont, United States