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

Restor3D9 sites in 1 country359 target enrollmentFebruary 2013

ConditionsOsteoarthritis of the Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis of the Knee
Sponsor: Restor3D
Enrollment: 359
Locations: 9
Primary Endpoint: 2011 Knee Society Score
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

October 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Restor3D

Responsible Party

Sponsor

Eligibility Criteria

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