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

June 10, 2024 updated by: Smith & Nephew, Inc.

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

209

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects receiving the JOURNEY™ II BCS Total Knee System

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Journey II BCS TKA
Subjects who previously received 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of ITB Friction Pain
Time Frame: 6 months post-operatively
6 months post-operatively

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
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
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
Time Frame: 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

June 21, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimated)

October 12, 2012

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011JBCK151

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis, Knee

Clinical Trials on TKA with Journey II BCS Total Knee System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe