JOURNEY II XR Safety and Effectiveness PMCF

• ClinicalTrials.gov Identifier: NCT03136887
• Recruitment Status: Active, not recruiting
• First Posted: May 2, 2017
• Last Update Posted: January 18, 2020
• Sponsor: Smith & Nephew, Inc.
• Information provided by (Responsible Party): Smith & Nephew, Inc.

Study Description

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.

Condition or disease	Intervention/treatment
Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee; Unilateral Post-Traumatic Osteoarthritis of Knee; Knee Osteoarthritis; Degenerative Arthritis Peripheral Joint; Failed Osteotomies; Failed Unicompartmental Replacement	Device: 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 Design

• Study Type: Observational
• Actual Enrollment: 176 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective, Multicenter, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of the JOURNEY™ II XR Total Knee System
• Actual Study Start Date: July 28, 2017
• Estimated Primary Completion Date: April 2029
• Estimated Study Completion Date: April 2029

Groups and Cohorts

Group/Cohort	Intervention/treatment
JOURNEY II XR TKA; This is a single arm study, all subjects will receive JOURNEY II XR TKA	Device: JOURNEY II XR Total Knee System; JOURNEY II XR Total Knee System

Outcome Measures

Primary Outcome Measures :

1. Implant survival rate [ Time Frame: 10 years ]
   Did knee survive with no revision through 10 years

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from their orthopedic surgeons practice.

Criteria

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.).

Contacts and Locations

Locations

United States, California

Loma Linda University Dept. of Orthopaedic Surgery

Loma Linda, California, United States, 92354

United States, Florida

Holy Cross Orthopedic Institute

Fort Lauderdale, Florida, United States, 33334

United States, Illinois

Castle Orthopaedics & Sports Medicine, S.C.

Aurora, Illinois, United States, 60504

Midwest Orthopaedics at Rush

Chicago, Illinois, United States, 60612

United States, Maryland

Anne Arundel Medical Center

Annapolis, Maryland, United States, 21401

United States, Michigan

DeClaire LaMacchia Orthopaedic Institute

Rochester, Michigan, United States, 48307

United States, Nevada

Reno Orthopaedic Center

Reno, Nevada, United States, 89503

United States, New Jersey

Mercer Bucks Orthopaedics

Hamilton, New Jersey, United States, 08691

United States, New York

NYU Hospital for Joint Diseases / NYU Langone Medical Center

New York, New York, United States, 10003

Hospital for Special Surgery

New York, New York, United States, 10021

Columbia University Center for Hip & Knee Replacement

New York, New York, United States, 10032

United States, Ohio

The Lindner Research Center at the Christ Hospital

Cincinnati, Ohio, United States, 45219

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

United States, Washington

Providence Regional Medical Center Everett

Everett, Washington, United States, 98201

Sponsors and Collaborators

Smith & Nephew, Inc.

Investigators

• Study Chair: Stacy Leake-Gardner; Smith & Nephew, Inc.

More Information

Publications:

Singh JA, Lewallen DG. Time trends in the characteristics of patients undergoing primary total knee arthroplasty. Arthritis Care Res (Hoboken). 2014 Jun;66(6):897-906. doi: 10.1002/acr.22233.

Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6. Review.

Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. Epub 2007 Aug 27. Review.

Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15.

Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. Review.

NIH Consensus Panel. NIH Consensus Statement on total knee replacement December 8-10, 2003. J Bone Joint Surg Am. 2004 Jun;86(6):1328-35. Review.

Dowsey MM, Gunn J, Choong PF. Selecting those to refer for joint replacement: who will likely benefit and who will not? Best Pract Res Clin Rheumatol. 2014 Feb;28(1):157-71. doi: 10.1016/j.berh.2014.01.005. Review.

Gidwani S, Fairbank A. The orthopaedic approach to managing osteoarthritis of the knee. BMJ. 2004 Nov 20;329(7476):1220-4. Review.

Parvizi J, Hanssen AD, Spangehl MJ. Total knee arthroplasty following proximal tibial osteotomy: risk factors for failure. J Bone Joint Surg Am. 2004 Mar;86(3):474-9.

• Responsible Party: Smith & Nephew, Inc.
• ClinicalTrials.gov Identifier: NCT03136887
• Other Study ID Numbers: 16-4049-06; U1111-1191-7751 ( Other Identifier: WHO )
• First Posted: May 2, 2017
• Last Update Posted: January 18, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Arthritis; Osteoarthritis; Osteoarthritis, Knee; Rheumatoid Vasculitis; Vasculitis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis, Rheumatoid; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases; Systemic Vasculitis