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

Primary Purpose

Osteoarthritis, Knee

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TKA with Journey II BCS Total Knee System
Sponsored by
Smith & Nephew, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Degenerative Knee Disease, TKA

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Joint Replacement Institute at St. Vincent Medical Center
  • Fort Wayne Orthopedics
  • Methodist Sports Medicine/The Orthopedic Specialist
  • Hospital for Special Surgery
  • OrthoCarolina
  • Wake Forest University
  • Wellington Orthopaedics
  • Cincinnati Orthopaedic Research Institute
  • Minimally Invasive Orthopaedics
  • Tennessee Orthopaedic Clinics
  • San Antonio Orthopaedic Specialists
  • Evergreen Orthopaedic Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Journey II BCS TKA

Arm Description

Subjects having TKA with Journey II BCS Total Knee System

Outcomes

Primary Outcome Measures

Rate of ITB Friction Pain

Secondary Outcome Measures

Adverse Events
Radiographic Evaluation
Knee Society Score

Full Information

First Posted
June 21, 2012
Last Updated
January 17, 2023
Sponsor
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01705067
Brief Title
Safety and Efficacy of the Journey II BCS Total Knee System
Acronym
NIMBLE
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 Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Degenerative Knee Disease, TKA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
209 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Journey II BCS TKA
Arm Type
Other
Arm Description
Subjects having TKA with Journey II BCS Total Knee System
Intervention Type
Device
Intervention Name(s)
TKA with Journey II BCS Total Knee System
Other Intervention Name(s)
Journey II BCS
Intervention Description
TKA with Journey II BCS Total Knee System
Primary Outcome Measure Information:
Title
Rate of ITB Friction Pain
Time Frame
6 months post-operatively
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachael Winter
Organizational Affiliation
rachael.winter@smith-nephew.com
Official's Role
Study Director
Facility Information:
Facility Name
Joint Replacement Institute at St. Vincent Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Fort Wayne Orthopedics
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Methodist Sports Medicine/The Orthopedic Specialist
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021-4892
Country
United States
Facility Name
OrthoCarolina
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1070
Country
United States
Facility Name
Wellington Orthopaedics
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Cincinnati Orthopaedic Research Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Minimally Invasive Orthopaedics
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Tennessee Orthopaedic Clinics
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
San Antonio Orthopaedic Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Evergreen Orthopaedic Clinic
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy of the Journey II BCS Total Knee System

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