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

Osteoarthritis Clinical Trial

— STEPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251522
• Other study ID #: 14-001
• Status: Completed
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2023
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 873
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• ConforMIS Total Knee Replacement System
Total knee replacement system using a patient specific implant.
• Off-the-Shelf Knee Replacement System
Total knee replacement system not using a patient specific implant.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Outcome time differences between the two groups	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	Outcomes questionnaire- Knee Society Score	Comparing different patient outcome scores between the two groups	At least 6 months post op
Secondary	Outcomes questionnaire- KOOS	Comparing different patient outcome scores between the two groups	At least 6 months post op
Secondary	Outcomes questionnaire- Forgotten Joint Score	Comparing different patient outcome scores between the two groups	At least 6 months post op