A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System

October 23, 2023 updated by: Restor3D
This study is a retrospective, multi-center study, with one single remote follow up contact. This study will include a minimum of 80 patients and a maximum 100 patients who have been treated with the ConforMIS iTotal PS knee product.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be contacted either by phone or email for a single remote follow-up. Retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available. . All data will be collected from existing medical records and from single follow up call/email.

  • Demographics and Medical History
  • Pre & Post-Operative Data including Range of Motion
  • Surgical Data
  • Survivorship (phone/email or last known visit)

  • Patient Reported Outcomes (phone/email single time point visit)

    • Patient Satisfaction
    • KOOS Jr.

Study Type

Observational

Enrollment (Actual)

93

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
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Orthopaedic Alliance
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • Scott Orthopedic Center

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

Individuals who are 18 years or older and have received a ConforMIS iTotal PS knee replacement to treat any condition indicated on the device's instructions for use.

Description

Inclusion Criteria:

  1. Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement.
  2. Over 18 Years of age

Exclusion Criteria:

1. BMI > 40

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
ConforMIS PS Group
Patients who have undergone a total knee replacement with the ConforMIS iTotal PS Knee Replacement System
Device: iTotal Posterior Stabilized (PS) Knee Replacement System
Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics and Medical History
Time Frame: 1 year
Demographics and medical history gathered from medical records
1 year
Pre and Post Operative Range of Motion
Time Frame: 1 year
Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits
1 year

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 (Actual)

April 24, 2017

Primary Completion (Actual)

August 4, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

September 15, 2017

First Submitted That Met QC Criteria

September 18, 2017

First Posted (Actual)

September 20, 2017

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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