A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf (STEPS)

October 23, 2023 updated by: Restor3D

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

It has been noted that patients "dramatically overestimate their functional ability early after surgery." Despite use of assistive devices increasing and functional testing scores decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome questionnaires will be administered and functional testing will be conducted on all patients to capture these changes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 that the patients are familiar with.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
873

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

  • Germany
      • Kassel, Germany
        • Vitos Orthopädische Klinik Kassel
      • Neutraubling, Germany
        • MedArtes
      • Radebeul, Germany
        • Elblandkliniken Stiftung
      • Stuttgart, Germany
        • Sportklinik Stuttgart
  • United States
    • Colorado
      • Parker, Colorado, United States, 80134
        • Denver-Vail Orthopedics
    • Florida
      • Fort Myers, Florida, United States, 33919
        • Institute for Orthopaedic Surgery & Sports Medicine
      • Miami, Florida, United States, 33176
        • Baptist Health South Florida
      • Port Saint Lucie, Florida, United States, 34996
        • Coastal Orthopaedic & Sports Medicine Ctr
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Bethesda Orthopedic
    • Massachusetts
      • Woburn, Massachusetts, United States, 01801
        • Excel Orthopaedic Specialists
    • Michigan
      • Battle Creek, Michigan, United States, 49015
        • Great Lakes Bone & Joint Center
      • West Bloomfield, Michigan, United States, 48323
        • Lederman-Kwartowitz Center for Orthopedics and Sports Medicine
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Orthopaedic Institute of Henderson
    • New York
      • Potsdam, New York, United States, 13676
        • St. Lawrence Health System
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Orthopedic Specialties of Spartanburg
    • Texas
      • Cypress, Texas, United States, 77429
        • Advanced Orthopedics & Sports Medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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 at least 6 months post-op and doing well
  • Patient has had a total CR knee implant
  • > 18 years of age

Exclusion Criteria:

  • Simultaneous bilateral procedure occurred
  • 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ConforMIS iTotal Knee Replacement System
Patients who have had an iTotal knee replacement at least 6 months prior to testing
Device: ConforMIS Total Knee Replacement System
Total knee replacement system using a patient specific implant.
Off-the-Shelf Knee Replacement System
Patients who have had an off-the-shelf knee replacement at least 6 months prior to testing
Device: Off-the-Shelf Knee Replacement System
Total knee replacement system not using a patient specific implant.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Outcome time differences between the two groups
Time Frame: at least 6 months post-op
The study primary endpoint is to compare functional testing time between patients implanted with the iTotal implant verses the off-the-shelf implants
at least 6 months post-op

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Outcomes questionnaire- Knee Society Score
Time Frame: At least 6 months post op
Comparing different patient outcome scores between the two groups
At least 6 months post op
Outcomes questionnaire- KOOS
Time Frame: At least 6 months post op
Comparing different patient outcome scores between the two groups
At least 6 months post op
Outcomes questionnaire- Forgotten Joint Score
Time Frame: At least 6 months post op
Comparing different patient outcome scores between the two groups
At least 6 months post op

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Restor3D

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Tait, MD, Orthopaedic Institute of Henderson
  • Study Chair: Mary O'Connor, MD, Yale University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-001

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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