A Single Time-Point Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System Versus Off-the-Shelf

October 23, 2023 updated by: Restor3D

A Single Time-Point Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System Versus Off-the-Shelf Knee Replacement Systems

This study is designed to compare outcome data for patients who have recently undergone surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter referred to as the "iTotal") versus those who have undergone surgery with Off-the-Shelf (OTS) systems.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-time point study that will be conducted in the US.To compare outcomes of these two study groups, this study will include routine office questionnaires such as the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS).The functional testing used in this study consists of tests that physical therapists use daily as objective methods to assess patients' functional status. The testing is designed to closely mimic daily activities with which the subjects are familiar.

Study Type

Observational

Enrollment (Actual)

31

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
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Bethesda Orthopedic

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

The study will include a 1:1 ratio of patients enrolled into both the iTotal arm and the off-the-shelf total knee arm.

Description

Inclusion Criteria:

  • Implant must be a minimum of 6 months post-op and doing well in the opinion of site staff
  • Subject has had a knee replacement utilizing a fixed bearing PS (Posterior Stabilized) implant design
  • > 18 years of age
  • Willingness to participate in the clinical study, to give informed consent, and to perform all evaluations

Exclusion Criteria:

  • Simultaneous or staged bilateral procedure
  • BMI > 40
  • Other physical disability that requires an aid for walking or disability affecting the hips, spine, contralateral knee or other joint that limits function
  • Participation in another clinical study which would confound results
  • Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons

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

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
iTotal PS KRS
Patients who have had an iTotal (posterior stabilized) knee replacement at least 6 months prior to testing.
Device: iTotal PS Knee Replacement System
Total Knee Replacement systems (Patient Specific)
Off-the-Shelf KRS
Patients who have had an off-the-shelf (posterior stabilized) knee replacement at least 6 months prior to testing.
Device: Off-the-Shelf Knee Replacement System
Total Knee Replacement systems (Off-the-shelf)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional testing differences
Time Frame: At least 6 months post-surgery
Physical therapy functional testing between the iTotal PS and off-the-shelf PS implants
At least 6 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Clinical Rating Score
Time Frame: At least 6 months post-surgery
Comparison of scores and sub-scores from the following questionnaires between the study arms
At least 6 months post-surgery
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: At least 6 months post-surgery
Comparison of scores and sub-scores from the following questionnaires between the study arms
At least 6 months post-surgery

Collaborators and Investigators

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

Sponsor

Restor3D

Investigators

  • Principal Investigator: Christopher Cannova, MD, Bethesda Orthopedic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 16, 2016

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 10, 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

  • 15-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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