JOURNEY™ II CR Total Knee System

A Prospective, Non-randomized, Single Cohort, Multicenter Study to Evaluate the Clinical Outcomes of Total Knee Arthroplasty (TKA) Using the JOURNEY™ II CR Total Knee System

The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: JOURNEY™ II CR Total Knee System (J II CR TKS)

Detailed Description

This is a prospective, non-randomized, single cohort, multicenter study to evaluate the clinical outcomes of TKA using the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement. One hundred and seventy (170) subjects will be enrolled at up to 18 clinical sites globally. Follow-up clinical assessments will be performed at 3 months, 1 year, 2 years, 5 years, and 10 years post-operatively.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Parc Taulí Servei de Cirurgia Ortopèdica I Traumatologia
• United Kingdom
  • Stanmore, United Kingdom
    • Royal National Orthopaedic Hospital NHS Trust
  • Whitechapel, United Kingdom
    • Barts Health NHS Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Orthopedic Institute of the West
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Health System Research Institute, Inc
  • New York
    • New York, New York, United States, 10032
      • Center for Hip and Knee Replacement at Columbia University Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Research Center, Musculo-Skeletal Division - The Christ Hospital Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Subjects MUST meet ALL of the following criteria for inclusion in the study:

• Has signed the IRB/EC approved ICF specific to this study prior to study participation
• Is a male or female ≥ 22 and ≤ 75 years of age presenting with degenerative joint disease (DJD) of the knee

• Is a candidate for primary total knee arthroplasty with the JOURNEY™ II CR Total Knee System due to DJD, defined by one of the following:

  • Post-traumatic arthritis
  • Osteoarthritis
  • Degenerative arthritis
• Is able to read and understand the approved Informed Consent Form and Patient Reported Outcome (PRO) assessments (written and oral)
• Is in general good health (as determined by the Investigator) based on screening assessments and medical history
• Is independent, ambulatory, and can comply with all post-operative evaluations
• plans to be available through ten (10) years post-operative follow-up

Exclusion Criteria:

• Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:

• Any of the following conditions in the index joint:

  • does not require patella resurfacing
  • has received a TKA or unicondylar arthroplasty
  • has inadequate bone stock to support the device (e.g. severe osteopenia/osteoporosis)

• Any of the following conditions in the contralateral joint:

  • has enrolled in the study for the contralateral knee
  • has received TKA as a revision for a failed total or unicondylar knee arthroplasty
  • has received a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning, as determined by Investigator

• Any of the following conditions of the hip:

  • received contralateral or ipsilateral revision hip arthroplasty
  • has ipsilateral hip arthritis resulting in flexion contracture
  • has received a ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty, that is not fully healed and well-functioning, as determined by Investigator
• Has diagnosis of an immunosuppressive disorder
• Has presence of malignant tumor, metastatic, or neoplastic disease
• Has family history of severe osteoporosis/osteopenia
• Has a known allergy to study device or one or more of its components
• Has conditions that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
• Is receiving medication for the diagnosis of fibromyalgia
• has a lower extremity condition causing abnormal or restricted ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture)
• Is pregnant or plans to become pregnant during the study
• Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study and complete PROs, as determined by Investigator
• Has a BMI>40
• Is currently enrolled in or has participated in another investigational drug, biologic, or device study within 3 months of enrollment
• Is currently involved in personal injury litigation or a worker's compensation claim
• Is facing current or impending incarceration
• Is known to be at risk for lost to follow-up, or failure to return for scheduled visits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Device:JOURNEY™ II CR Total Knee System (J II CR TKS); Subjects having TKA with JOURNEY™ II CR Total Knee System	Device: JOURNEY™ II CR Total Knee System (J II CR TKS); TKA with Journey II CR Total Knee System; Other Names: JOURNEY™ II CR; (J II CR TKS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Equivalence in 1 year post-operative mean Range of Motion (ROM) in subjects receiving the J II CR TKS as compared to the literature reference mean ROM	1 year post-op analysis
Non-inferiority of the survival rate of the J II CR TKS with the reference survival rate of a literature reference at 5 and 10-years post-operatively	Up to 10 year post-operative analysis

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical Outcomes: EuroQol 5D (EQ-5D) scale	Pre-Op to 10 yrs
Clinical Outcomes: 2011 Knee Society Score (2011 KSS) clinical evaluation	Pre-Op to 10 yrs
Clinical Outcomes: Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty (SAPSS	Pre-Op to 10 yrs
Health Economic Endpoints : Physical therapy visit quantification/duration	30, 60, and 90-day hospital re-admission rate
Health Economic Endpoints: Discharge destination(s)/length of stay	30, 60, and 90 days
Health Economic Endpoints: Unscheduled professional visits (e.g. hospital, emergency room, orthopedic clinic, primary care physician)	30, 60, and 90 days
Health Economic Endpoints: Concomitant medications/procedures associated with the knee	30, 60, and 90 days
Safety Endpoints:Adverse events, to be evaluated by type, frequency, severity, and relatedness to the study treatment.	Pre-Op to 10 yrs
Safety Endpoints: Manipulations under anesthesia	Pre-Op to 10 yrs
Safety Endpoints: Radiographic analysis	Pre-Op to 10 yrs

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Rebecca McDonald, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimated): May 12, 2015

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; TKA; Degenerative Knee Disease
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 13-4049-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes