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

Completed

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT02251522

Run by

Restor3D

People needed

873

Starts

2014-10-01

Expected to finish

2016-12-01

Last updated by the study team

2023-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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