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

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ClinicalTrials.gov Identifier: NCT02251522
Recruitment Status : Completed
First Posted : September 29, 2014
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Osteoarthritis Device: ConforMIS Total Knee Replacement System Device: Off-the-Shelf Knee Replacement System

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.

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Study Type : Observational
Actual Enrollment : 873 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System Versus Off-the-Shelf Replacement
Actual Study Start Date : October 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Outcomes questionnaire- Knee Society Score [ Time Frame: At least 6 months post op ]
    Comparing different patient outcome scores between the two groups

  2. Outcomes questionnaire- KOOS [ Time Frame: At least 6 months post op ]
    Comparing different patient outcome scores between the two groups

  3. Outcomes questionnaire- Forgotten Joint Score [ Time Frame: At least 6 months post op ]
    Comparing different patient outcome scores between the two groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251522


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

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Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT02251522     History of Changes
Other Study ID Numbers: 14-001
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases