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NIMBLE: Safety and Efficacy of the Journey II BCS Total Knee System

Sponsor
Smith & Nephew, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01705067
Collaborator
(none)
209
Enrollment
12
Locations
1
Arm
144
Duration (Months)
17.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: TKA with Journey II BCS Total Knee System
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
209 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date :
Jun 1, 2012
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Journey II BCS TKA

Subjects having TKA with Journey II BCS Total Knee System

Device: TKA with Journey II BCS Total Knee System
TKA with Journey II BCS Total Knee System
Other Names:
  • Journey II BCS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of ITB Friction Pain [6 months post-operatively]

    Secondary Outcome Measures

    1. Adverse Events [6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively]

    2. 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]

    3. Knee Society Score [6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Joint Replacement Institute at St. Vincent Medical Center Los Angeles California United States 90057
    2 Fort Wayne Orthopedics Fort Wayne Indiana United States 46804
    3 Methodist Sports Medicine/The Orthopedic Specialist Indianapolis Indiana United States 46280
    4 Hospital for Special Surgery New York New York United States 10021-4892
    5 OrthoCarolina Charlotte North Carolina United States 28207
    6 Wake Forest University Winston-Salem North Carolina United States 27157-1070
    7 Wellington Orthopaedics Cincinnati Ohio United States 45220
    8 Cincinnati Orthopaedic Research Institute Cincinnati Ohio United States 45249
    9 Minimally Invasive Orthopaedics Columbus Ohio United States 43215
    10 Tennessee Orthopaedic Clinics Knoxville Tennessee United States 37923
    11 San Antonio Orthopaedic Specialists San Antonio Texas United States 78229
    12 Evergreen Orthopaedic Clinic Kirkland Washington United States 98034

    Sponsors and Collaborators

    • Smith & Nephew, Inc.

    Investigators

    • Study Director: Rachael Winter, rachael.winter@smith-nephew.com

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Smith & Nephew, Inc.
    ClinicalTrials.gov Identifier:
    NCT01705067
    Other Study ID Numbers:
    • 2011JBCK151
    First Posted:
    Oct 12, 2012
    Last Update Posted:
    Dec 1, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Smith & Nephew, Inc.
    Osteoarthritis, Degenerative Knee Disease, TKA
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee

    Study Results

    No Results Posted as of Dec 1, 2021