Safety and Efficacy of the Journey II BCS Total Knee System

Completed

Conditions studied: Osteoarthritis, Knee

In brief

Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.

Key facts

Study ID

NCT01705067

Run by

Smith & Nephew, Inc.

People needed

209

Starts

2012-06-01

Expected to finish

2023-07-31

Last updated by the study team

2024-06-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject received primary total knee arthroplasty with the JOURNEY™ II BCS Total Knee System due to degenerative joint disease
• Subject is willing to sign and date an IRB approved consent form
• Subject is of legal age to consent
• Subject plans to be available through ten (10) years postoperative follow-up
• Subject agrees to follow the study protocol

You may not qualify if…

• Subject received the JOURNEY™ II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
• Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
• Subject possesses a contralateral or ipsilateral revision hip arthroplasty
• Subject has ipsilateral hip arthritis resulting in flexion contracture
• At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:
• Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
• Contralateral primary total knee or unicondylar knee arthroplasty
• At the time of surgery, subject had an active infection or sepsis (treated or untreated)
• At the time of surgery, subject had presence of malignant tumor, metastatic, or neoplastic disease
• At the time of surgery, subject had conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
• At the time of surgery, subject had contralateral lower extremity condition causing abnormal ambulation
• Subject is pregnant or plans to become pregnant during the study
• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
• At the time of surgery, subject had a BMI>40
• At the time of enrollment, subject has a BMI>40
• Subject is enrolled in another investigational drug, biologic, or device study
• Subject is facing current or impending incarceration

Where it is running

• Joint Replacement Institute at St. Vincent Medical Center — Los Angeles, California, United States
• Fort Wayne Orthopedics — Fort Wayne, Indiana, United States
• Methodist Sports Medicine/The Orthopedic Specialist — Indianapolis, Indiana, United States
• Hospital for Special Surgery — New York, New York, United States
• OrthoCarolina — Charlotte, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Wellington Orthopaedics — Cincinnati, Ohio, United States
• Cincinnati Orthopaedic Research Institute — Cincinnati, Ohio, United States
• Minimally Invasive Orthopaedics — Columbus, Ohio, United States
• Tennessee Orthopaedic Clinics — Knoxville, Tennessee, United States
• San Antonio Orthopaedic Specialists — San Antonio, Texas, United States
• Evergreen Orthopaedic Clinic — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.