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

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01820650
• Other study ID #: 12-001
• Status: Terminated
• Start date: February 2013
• Est. completion date: October 2023

Study information

• Verified date: October 2023
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 359
• Est. completion date: October 2023
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• iTotal G2 CR Knee Replacement System
Total Knee replacement

Locations

Country	Name	City	State
United States	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	Advanced Orthopedics and Sports Medicine	Cypress	Texas
United States	Orthopaedic Instatute of Henderson	Henderson	Nevada
United States	Joint Replacement Associates	Houston	Texas
United States	Desert Orthopedic Center	Las Vegas	Nevada
United States	Mansfield Orthopaedics	Morrisville	Vermont
United States	Tennessee Orthopaedic Alliance	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2011 Knee Society Score		1 Year