A Retrospective Study of the iTotal CR Knee Replacement System

restor3d

Status: Completed

Conditions: Osteoarthritis

Treatments: Device: iTotal KRS

Study type: Observational

Funder types: Industry

Identifiers

NCT01564654

CCP 11-002

Details and patient eligibility

About

This study involves retrospective collection of data regarding the first approximately 100 iTotal Knee Replacement System surgeries and their short term outcomes at a small set of centers throughout the US.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical condition included in the approved Indications For Use
2. Has signed the informed consent form to allow review of medical records and collection of data therein.
3. > 18 years of age

Exclusion criteria

1. Treatment with iTotal in a manner inconsistent with Instructions for Use
2. Unwilling to sign then informed consent form

Trial design

89 participants in 1 patient group

iTotal KRS

Treatment:

Device: iTotal KRS