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

Smith & Nephew, Inc.9 sites in 3 countries170 target enrollmentSeptember 1, 2015

ConditionsOsteoarthritis, Knee

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: Smith & Nephew, Inc.
Enrollment: 170
Locations: 9
Primary Endpoint: 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
Status: Active, Not Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2015

End Date

June 1, 2028

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Smith & Nephew, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Exclusion Criteria

•1\. 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:

Outcomes

Primary Outcomes

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

Time Frame: Up to 10 year post-operative analysis

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

Time Frame: 1 year post-op analysis

Secondary Outcomes

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