A Retrospective Study of the iTotal CR Knee Replacement System

October 23, 2023 updated by: Restor3D

A Retrospective, Multi-Center Study to Evaluate the ConforMIS iTotal® CR (Cruciate Retaining) Total Knee Replacement System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Quinta, California, United States, 92253
        • STAR Orthopedics
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Preferred Orthopedics of the Palm Beaches
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Orthopaedic Alliance
    • Utah
      • Provo, Utah, United States, 84604
        • Central Utah Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have received an iTotal Knee replacement

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
iTotal KRS
Device: iTotal KRS
Total Knee Replacement System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Function
Time Frame: Average of 7 months post-operative
Range of Motion
Average of 7 months post-operative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Restor3D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 26, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimated)

March 28, 2012

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCP 11-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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