Safety and Efficacy of the Journey II BCS Total Knee System
NIMBLE
A Retro-Prospective, Non-randomized, Consecutive Series, SIngle Cohort, Multicenter Adaptive Design Study to Evaluate the Outcomes of Total Knee Arthroplasty (TKA) Using JOURNEY™ II BCS TotaL Knee SystEm (The NIMBLE Study)
1 other identifier
observational
209
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
October 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2023
CompletedJune 13, 2024
June 1, 2024
11.2 years
June 21, 2012
June 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of ITB Friction Pain
6 months post-operatively
Secondary Outcomes (3)
Adverse Events
6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
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
Knee Society Score
6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
Study Arms (1)
Journey II BCS TKA
Subjects who previously received TKA with Journey II BCS Total Knee System
Interventions
TKA with Journey II BCS Total Knee System
Eligibility Criteria
Subjects receiving the JOURNEY™ II BCS Total Knee System
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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Joint Replacement Institute at St. Vincent Medical Center
Los Angeles, California, 90057, United States
Fort Wayne Orthopedics
Fort Wayne, Indiana, 46804, United States
Methodist Sports Medicine/The Orthopedic Specialist
Indianapolis, Indiana, 46280, United States
Hospital for Special Surgery
New York, New York, 10021-4892, United States
OrthoCarolina
Charlotte, North Carolina, 28207, United States
Wake Forest University
Winston-Salem, North Carolina, 27157-1070, United States
Wellington Orthopaedics
Cincinnati, Ohio, 45220, United States
Cincinnati Orthopaedic Research Institute
Cincinnati, Ohio, 45249, United States
Minimally Invasive Orthopaedics
Columbus, Ohio, 43215, United States
Tennessee Orthopaedic Clinics
Knoxville, Tennessee, 37923, United States
San Antonio Orthopaedic Specialists
San Antonio, Texas, 78229, United States
Evergreen Orthopaedic Clinic
Kirkland, Washington, 98034, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
October 12, 2012
Study Start
June 1, 2012
Primary Completion
July 31, 2023
Study Completion
July 31, 2023
Last Updated
June 13, 2024
Record last verified: 2024-06