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

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

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Device: iTotal G2 CR Knee Replacement System

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 Type: Observational
• Enrollment (Actual): 359

Contacts and Locations

Study Locations

• United States
  • Florida
    • Atlantis, Florida, United States, 33462
      • JFK Medical Center
  • Maine
    • Bangor, Maine, United States, 04401
      • EMMC - Orthopaedic Surgery of Maine
  • Michigan
    • Battle Creek, Michigan, United States, 49015
      • Great Lakes Bone and Joint
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Orthopaedic Instatute of Henderson
    • Las Vegas, Nevada, United States, 89121
      • Desert Orthopedic Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Orthopaedic Alliance
  • Texas
    • Cypress, Texas, United States, 77429
      • Advanced Orthopedics and Sports Medicine
    • Houston, Texas, United States, 77030
      • Joint Replacement Associates
  • Vermont
    • Morrisville, Vermont, United States, 05661
      • Mansfield Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with osteoarthritis of the knee

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
2011 Knee Society Score	1 Year

Collaborators and Investigators

• Sponsor: Restor3D
• Investigators: Principal Investigator: Terry Clyburn, MD, The University of Texas Health Science Center, Houston; Study Director: Marc Quartulli, Restor3D

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: March 26, 2013
• First Submitted That Met QC Criteria: March 26, 2013
• First Posted (Estimated): March 29, 2013

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: osteoarthritis; knee replacement; patient-specific
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 12-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes