Flexion with the Journey II BCS Total Knee System. A Prospective, Non-randomized, Consecutive Series, Observational Study. - Flexion with the Journey II BCS Total Knee System

Sint Maartenskliniek0 sites62 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

January 10, 2018

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•Patient presents with non\-inflammatory knee osteoarthritis (radiologically confirmed), requiring total knee arthroplasty
•Patient is 40 to 70 years of age, inclusive
•Patient plans to be available for follow\-up through two years postoperative
•Patient is in stable health and is free of or treated for cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk
•Patient has \<10 degrees fixed (non\-correctable) varus or valgus deformity
•Orthopaedic surgeon is member of the Knee Reconstruction Unit SMK

•Patient is known to have insufficient femoral or tibial bone stock
•Patient has a BMI \>35
•Patient\*s expected physical activity after surgery is 2 or less on the UCLA Activity Scale
•Patient has had previous hip or knee replacement surgery in the last 6 months
•Patient is planned to have additional hip or contralateral knee replacement in the next 6 months
•Patient has had major, non\-arthroscopic surgery to the study knee, including osteotomy around the knee
•Patient has an active, local infection or systemic infection
•Patient has physical, emotional or neurological conditions that would compromise compliance with postoperative rehabilitation and follow\-up
•Patient has grade 3 collateral ligament insufficiency (complete tear of ligament)
•Patient has knee flexion \<90 degrees