Costs and Benefits of ConforMIS iTotal® Knee Replacement System Versus Standard Total Knee

October 23, 2023 updated by: Restor3D

Analysis of Procedure-related Costs and Proposed Benefits of the ConforMIS iTotal® Cruciate Retaining Knee Replacement System Versus Standard Total Knee

The purpose of this study is to evaluate the costs and benefits of the ConforMIS iTotal® total knee replacement system versus standard total knee arthroplasty.

This study is designed to illustrate the difference in cost between standard total knee replacements and the ConforMIS iTotal at a single institution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

STUDY DESIGN The study is a two-arm single-center, consecutively enrolled retrospective study. Patients enrolled will have previously received either an iTotal CR knee replacement or a standard total knee replacement. The study site will be located in the United States. A minimum of 100 with a maximum of 120 patients will be enrolled in each study arm for a maximum of 200 - 240 patients.

STUDY DURATION This study involves retrospective data collection of operative and peri-operative information to determine the cost impact of several surgical variables. The study will be complete when the retrospective data has been collected on up to 120 patients per arm.

Study Type

Observational

Enrollment (Actual)

235

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
    • Florida
      • Atlantis, Florida, United States, 33462
        • JFK Medical 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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have had a Total Knee Replacement performed by the Investigator and are at least 3 months post surgery.

Description

Inclusion Criteria:

  • Patient has received an iTotal or a standard total knee replacement
  • Willingness to participate in the clinical study and to give informed consent, if necessary, as determined during IRB review
  • >18 years of age

Exclusion Criteria:

  • Participation in another clinical study that could confound results
  • Patient is less than 3 months post-op

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: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ConforMIS iTotal® Knee Replacement
knee joint replacement
Device: ConforMIS iTotal® Knee Replacement
Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.
Other Names:
  • Total knee replacement
  • arthoplasty
  • TKA
  • iTotal
  • Standard total knee device
Standard Knee Replacements
knee joint replacement
Device: ConforMIS iTotal® Knee Replacement
Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.
Other Names:
  • Total knee replacement
  • arthoplasty
  • TKA
  • iTotal
  • Standard total knee device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op
Time Frame: 1 month
Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op
1 month
Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op
Time Frame: 3 months
Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op
3 months

Collaborators and Investigators

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

Sponsor

Restor3D

Investigators

  • Principal Investigator: Gregory Martin, MD, JFK Medical Center

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

July 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 12, 2013

First Posted (Estimated)

July 15, 2013

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

  • 13-001

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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