Safety and Efficacy of the Journey II BCS Total Knee System
- Conditions
- Osteoarthritis, Knee
- Interventions
- Device: TKA with Journey II BCS Total Knee System
- Registration Number
- NCT01705067
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief Summary
Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.
- Detailed Description
Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement. Pre-operative and operative assessments collected retrospectively. All postoperative assessments beginning at the 6 month post-operative time point collected prospectively.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 209
- Subject received primary total knee arthroplasty with the JOURNEYâ„¢ 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
-
Subject received the JOURNEYâ„¢ 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Journey II BCS TKA TKA with Journey II BCS Total Knee System Subjects who previously received TKA with Journey II BCS Total Knee System
- Primary Outcome Measures
Name Time Method Rate of ITB Friction Pain 6 months post-operatively
- Secondary Outcome Measures
Name Time Method Radiographic Evaluation Baseline and 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively Adverse Events 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively Knee Society Score 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
Trial Locations
- Locations (12)
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