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

CompletedOBSERVATIONAL
Enrollment

873

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

October 31, 2016

Study Completion Date

December 31, 2016

Conditions
Osteoarthritis
Interventions
DEVICE

ConforMIS Total Knee Replacement System

Total knee replacement system using a patient specific implant.

DEVICE

Off-the-Shelf Knee Replacement System

Total knee replacement system not using a patient specific implant.

Trial Locations (16)

13676

St. Lawrence Health System, Potsdam

20817

Bethesda Orthopedic, Bethesda

29303

Orthopedic Specialties of Spartanburg, Spartanburg

33176

Baptist Health South Florida, Miami

33919

Institute for Orthopaedic Surgery & Sports Medicine, Fort Myers

34996

Coastal Orthopaedic & Sports Medicine Ctr, Port Saint Lucie

48323

Lederman-Kwartowitz Center for Orthopedics and Sports Medicine, West Bloomfield

49015

Great Lakes Bone & Joint Center, Battle Creek

77429

Advanced Orthopedics & Sports Medicine, Cypress

80134

Denver-Vail Orthopedics, Parker

89052

Orthopaedic Institute of Henderson, Henderson

01801

Excel Orthopaedic Specialists, Woburn

Unknown

Vitos Orthopädische Klinik Kassel, Kassel

MedArtes, Neutraubling

Elblandkliniken Stiftung, Radebeul

Sportklinik Stuttgart, Stuttgart

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Restor3D

INDUSTRY

NCT02251522 - A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf | Biotech Hunter | Biotech Hunter