JOURNEY™ II CR Total Knee System

NCT02440672 | Active Not Recruiting FDA Device

• 1 other identifier: 13-4049-06
• Study Type: observational
• Target: 170
• Locations: 3 countries
• Sites: 9

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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; TKA; Degenerative Knee Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

Study Arms (1)

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)

Interventions

JOURNEY™ II CR Total Knee System (J II CR TKS) DEVICE

TKA with Journey II CR Total Knee System

Also known as: JOURNEY™ II CR, (J II CR TKS)

Device:JOURNEY™ II CR Total Knee System (J II CR TKS)

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who present with DJD of the knee will be screened to determine if they meet all inclusion and no exclusion criteria. If all entry criteria are achieved, the subject will be eligible to participate in the study. All general and indication-specific entry criteria must be met prior to study entry.

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (9)

Orthopedic Institute of the West

Phoenix, Arizona, 85054, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Anne Arundel Health System Research Institute, Inc

Annapolis, Maryland, 21401, United States

Location

Center for Hip and Knee Replacement at Columbia University Medical Center

New York, New York, 10032, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

The Lindner Research Center, Musculo-Skeletal Division - The Christ Hospital Health Network

Cincinnati, Ohio, 45219, United States

Location

Hospital Parc Taulí Servei de Cirurgia Ortopèdica I Traumatologia

Barcelona, Spain

Location

Royal National Orthopaedic Hospital NHS Trust

Stanmore, United Kingdom

Location

Barts Health NHS Trust

Whitechapel, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Lucy O'Mara

  Smith & Nephew, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 12, 2015
• Study Start: September 1, 2015
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

GB (2); US (6); ES (1)