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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Robert Tait, MD; Orthopaedic Institute of Henderson
• Study Chair: Mary O'Connor, MD; Yale University

More Information

• Responsible Party: ConforMIS, Inc.
• ClinicalTrials.gov Identifier: NCT02251522
• Other Study ID Numbers: 14-001
• First Posted: September 29, 2014
• Last Update Posted: May 15, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases