A Retrospective Study of the iTotal CR Knee Replacement System

Completed

• Conditions: Osteoarthritis
• Interventions: Device: iTotal KRS

• Registration Number: NCT01564654
• Lead Sponsor: Restor3D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-28
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2017-07-13
• Results First Submitted QC: 2020-12-30
• Results First Posted: 2021-01-20
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
iTotal KRS	iTotal KRS	-

Primary Outcome Measures

Name	Time	Method
Knee Function	Average of 7 months post-operative	Range of Motion

Secondary Outcome Measures

Name	Time	Method
Number of Transfusions	Initial hospital stay	Number of knees that required a blood transfusion during the initial hospital stay post-operative
Manipulations Under Anesthesia	Up to 7 months post-operative	Number of knees that required a subsequent procedure to restore knee range of motion
Revision Rate	Average of 7 months	Number of knees that required a reoperation to remove/replace/add implant components

Trial Locations

Locations (4)

STAR Orthopedics; 🇺🇸 La Quinta, California, United States

Central Utah Clinic; 🇺🇸 Provo, Utah, United States

Preferred Orthopedics of the Palm Beaches; 🇺🇸 Boynton Beach, Florida, United States

Tennessee Orthopaedic Alliance; 🇺🇸 Nashville, Tennessee, United States