JOURNEY™ II CR Total Knee System

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02440672
• Other study ID #: 13-4049-06
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: February 2027

Study information

• Verified date: June 2023
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: February 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• JOURNEY™ II CR Total Knee System (J II CR TKS)
TKA with Journey II CR Total Knee System

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  Spain,  United Kingdom, 

Outcome

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