A Prospective, Multicenter, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of the JOURNEY™ II XR Total Knee System

Status: Active_not_recruiting
Location: See all (14) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants will be implanted with the JOURNEY II XR total knee system.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 75
Healthy Volunteers: f
View:

• require TKA due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, failed osteotomies, or failed unicompartmental replacement

• have all cruciate and collateral ligaments intact in the index joint

• adult patients that in the judgement of the Investigator are skeletally mature

• be willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires

• consent to participate in the study by signing the IRB/EC approved informed consent form

Locations
United States
California
Loma Linda University Dept. of Orthopaedic Surgery
Loma Linda
Florida
Holy Cross Orthopedic Institute
Fort Lauderdale
Illinois
Castle Orthopaedics & Sports Medicine, S.C.
Aurora
Midwest Orthopaedics at Rush
Chicago
Maryland
Anne Arundel Medical Center
Annapolis
Michigan
DeClaire LaMacchia Orthopaedic Institute
Rochester
New Jersey
Mercer Bucks Orthopaedics
Hamilton
Nevada
Reno Orthopaedic Center
Reno
New York
Columbia University Center for Hip & Knee Replacement
New York
Hospital for Special Surgery
New York
NYU Hospital for Joint Diseases / NYU Langone Medical Center
New York
Ohio
The Lindner Research Center at the Christ Hospital
Cincinnati
Oregon
Oregon Health & Science University
Portland
Washington
Providence Regional Medical Center Everett
Everett
Time Frame
Start Date: 2017-07-28
Completion Date: 2029-04
Participants
Target number of participants: 176
Treatments
JOURNEY II XR TKA
This is a single arm study, all subjects will receive JOURNEY II XR TKA
Sponsors
Leads: Smith & Nephew, Inc.

This content was sourced from clinicaltrials.gov