JOURNEY II XR Safety and Effectiveness PMCF

Active, not recruiting

• Conditions: Unilateral Post-Traumatic Osteoarthritis of Knee; Knee Osteoarthritis; Degenerative Arthritis Peripheral Joint; Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee; Failed Unicompartmental Replacement; Failed Osteotomies
• Interventions: Device: JOURNEY II XR Total Knee System

• Registration Number: NCT03136887
• Lead Sponsor: Smith & Nephew, Inc.

Brief Summary

This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants will be implanted with the JOURNEY II XR total knee system.

Detailed Description

Total knee arthroplasty (TKA) is considered the most beneficial and cost-effective treatment for end-stage knee arthritis and is the most frequently performed joint replacement surgery. TKA is also indicated for earlier osteoarthritis (OA) interventions, such as osteotomy or unicompartmental replacement, when additional treatment is warranted. One device option available once the decision is made to perform TKA is the JOURNEY II XR Total Knee System. The JOURNEY II XR Total Knee System is designed to be a more "natural feeling" total knee replacement. The goal of the JOURNEY II XR is to enable a higher level of function after total knee replacement by relieving pain and restoring the ability to participate in active lifestyles. The main aim of this study is to generate long-term safety and performance data for the JOURNEY™ II XR Total Knee System. Effectiveness information such as short- and long-term function, subject satisfaction, and quality of life will also be measured.

Study Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-02
• Study Start: 2017-07-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Primary Completion: 2029-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

1. require TKA due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, failed osteotomies, or failed unicompartmental replacement
2. have all cruciate and collateral ligaments intact in the index joint
3. adult patients that in the judgement of the Investigator are skeletally mature
4. be willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
5. consent to participate in the study by signing the IRB/EC approved informed consent form

Exclusion Criteria

1. have any of the following conditions in the index joint:

   • Intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment
   • Significant varus or valgus deformities (>15º)
   • Incomplete or insufficient tissue surrounding the knee
   • Collateral ligament insufficiency
   • Inadequate bone stock to support the device (e.g., severe osteopenia/osteoporosis) or will require use of femoral and tibial stems
   • History of prior TKA

2. have any of the following conditions in the contralateral joint:

   • a previous TKA as a revision for a failed total or unicondylar knee arthroplasty
   • a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning as determined by the Investigator

3. have any of the following conditions of the hip:

   • a previous contralateral or ipsilateral revision hip arthroplasty
   • ipsilateral hip arthritis resulting in flexion contracture
   • previously received an ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty that is not fully healed and well-functioning as determined by the Investigator

4. have a diagnosis of an immunosuppressive disorder

5. have an active infection, treated or untreated, systemic or at the site of the planned surgery

6. have conditions that may interfere with the TKA survival or outcome, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease

7. have a BMI > 40

8. be facing current or impending incarceration

9. have a known allergy to study device or one or more of its components

10. be pregnant or have plans to become pregnant during the course of the study

11. have, in the opinion of the Investigator, an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse

12. be enrolled in another drug, biologic, or device study within 30 days of screening

13. be known to be at risk for lost to follow-up or failure to return for scheduled visits

14. during the surgery, have a cruciate ligament tibial bone island that is secured with any fixative device (e.g. screw, plate, etc.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
JOURNEY II XR TKA	JOURNEY II XR Total Knee System	This is a single arm study, all subjects will receive JOURNEY II XR TKA

Primary Outcome Measures

Name	Time	Method
Implant survival rate	10 years	Did knee survive with no revision through 10 years

Secondary Outcome Measures

Name	Time	Method
Quality of Life - FJS	10 years	Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire
Quality of Life - KOOS	10 years	Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS) questionnaire
Physiotherapy (PT) utilization - Period of visits	6 Months Post-operatively	Time period during which PT appointments are required up to 6 months after surgery
Quality of Life - ABC scale	10 years	Patient Reported Outcomes using Activities-specific Balance Confidence (ABC) questionnaire
Radiographic outcomes	10 years	X-rays of index joint
Adverse Events (AEs)	10 years	All AEs will be collected and reported
Knee function	10 years	Lateral Step-Up Test
Quality of Life - EQ-5D - 3L	10 years	Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire
Quality of Life - SAPSS	10 years	Patient Reported Outcomes using Self-Administered Patient Satisfaction Score (SAPSS) questionnaire
Physiotherapy (PT) utilization - No. of visits	6 Months Post-operatively	Number of PT visits required up to 6 months after surgery

Trial Locations

Locations (14)

DeClaire LaMacchia Orthopaedic Institute; 🇺🇸 Rochester, Michigan, United States

Anne Arundel Medical Center; 🇺🇸 Annapolis, Maryland, United States

Mercer Bucks Orthopaedics; 🇺🇸 Hamilton, New Jersey, United States

Reno Orthopaedic Center; 🇺🇸 Reno, Nevada, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

The Lindner Research Center at the Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Columbia University Center for Hip & Knee Replacement; 🇺🇸 New York, New York, United States

Loma Linda University Dept. of Orthopaedic Surgery; 🇺🇸 Loma Linda, California, United States

Midwest Orthopaedics at Rush; 🇺🇸 Chicago, Illinois, United States

Castle Orthopaedics & Sports Medicine, S.C.; 🇺🇸 Aurora, Illinois, United States

Holy Cross Orthopedic Institute; 🇺🇸 Fort Lauderdale, Florida, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

NYU Hospital for Joint Diseases / NYU Langone Medical Center; 🇺🇸 New York, New York, United States

Providence Regional Medical Center Everett; 🇺🇸 Everett, Washington, United States