A Retrospective Study of the iTotal CR Knee Replacement System

Completed

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT01564654

Run by

Restor3D

People needed

89

Starts

2012-01-01

Expected to finish

2013-01-01

Last updated by the study team

2023-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• STAR Orthopedics — La Quinta, California, United States
• Preferred Orthopedics of the Palm Beaches — Boynton Beach, Florida, United States
• Tennessee Orthopaedic Alliance — Nashville, Tennessee, United States
• Central Utah Clinic — Provo, Utah, United States

Full record on ClinicalTrials.gov

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