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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01705067
Recruitment Status : Active, not recruiting
First Posted : October 12, 2012
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: TKA with Journey II BCS Total Knee System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 209 participants
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 : June 2012
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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 Name: Journey II BCS




Primary Outcome Measures :
  1. Rate of ITB Friction Pain [ Time Frame: 6 months post-operatively ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively ]
  2. Radiographic Evaluation [ Time Frame: 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 [ Time Frame: 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705067


Locations
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United States, California
Joint Replacement Institute at St. Vincent Medical Center
Los Angeles, California, United States, 90057
United States, Indiana
Fort Wayne Orthopedics
Fort Wayne, Indiana, United States, 46804
Methodist Sports Medicine/The Orthopedic Specialist
Indianapolis, Indiana, United States, 46280
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021-4892
United States, North Carolina
OrthoCarolina
Charlotte, North Carolina, United States, 28207
Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1070
United States, Ohio
Wellington Orthopaedics
Cincinnati, Ohio, United States, 45220
Cincinnati Orthopaedic Research Institute
Cincinnati, Ohio, United States, 45249
Minimally Invasive Orthopaedics
Columbus, Ohio, United States, 43215
United States, Tennessee
Tennessee Orthopaedic Clinics
Knoxville, Tennessee, United States, 37923
United States, Texas
San Antonio Orthopaedic Specialists
San Antonio, Texas, United States, 78229
United States, Washington
Evergreen Orthopaedic Clinic
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Study Chair: Omar Merhi Smith & Nephew, Inc.

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01705067     History of Changes
Other Study ID Numbers: 2011JBCK151
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Smith & Nephew, Inc.:
Osteoarthritis, Degenerative Knee Disease, TKA
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases