A Prospective, Multicenter Study to Evaluate the Conformis iTotal Identity Knee Replacement System

Restor3D2 sites in 1 country22 target enrollmentOctober 12, 2020

ConditionsOsteoarthritis, Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: Restor3D
Enrollment: 22
Locations: 2
Primary Endpoint: Pain and function
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective multicenter study located in the United States. Subjects will be implanted with an iTotal Identity Knee Replacement System and followed for 10 years post implantation.

Registry

clinicaltrials.gov

Start Date

October 12, 2020

End Date

December 14, 2022

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 Identity CR KRS
•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 with complete development of musculoskeletal structures

Exclusion Criteria

•Simultaneous bilateral procedure required
•BMI \> 40
•Active malignancy (defined as a history of any invasive malignancy - except nonmelanoma skin cancer), unless subject 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 (defined as HbA1c \>7 or Investigator discretion)
•Neuromuscular conditions which prevent subject from participating in study activities
•Active local or systemic infection which precludes TKR procedure
•Immunocompromised in the opinion of the Investigator
•Medically diagnosed fibromyalgia or similar conditions that might impact the subject's ability to differentiate source of pain
•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 on, to an extent that the procedure is unjustified

Outcomes

Primary Outcomes

Pain and function

Time Frame: 2 years post implantation

Measured by 2011 Knee Society Clinical Rating Score (objective knee score 0-125, function score 0-100, satisfaction score 0-40, expectation score 0-15 with higher scores meaning better outcome)

Secondary Outcomes

Revision rate(Post implantation up to 10 years)
Length of procedure(Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours))
Number of patients demonstrating radiographic loosening, radiolucency(Post implantation up to 10 years)
Post-operative hip-knee-ankle limb alignment (with 180 degrees being the expected outcome, plus or minus 5 degrees), if long leg x-rays available(Post implantation up to 10 years)
Length of hospital stay in hours(Time from patient admission to hospital before surgery til discharge from hospital (up to 72 hours))
blood loss during surgery(Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours))
blood transfusion rates(Implant procedure from time the patient enters the operating room til time the surgery is complete and patient exits the operating room (up to 6 hours))
Incidence of major procedure-related and device-related complications, including infection rate(Post implantation up to 10 years)