JOURNEY II XR Safety and Effectiveness PMCF

NCT ID: NCT03136887

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 176 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-28
• Study Completion Date: 2029-04-30

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.

Conditions

Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee; Unilateral Post-Traumatic Osteoarthritis of Knee; Knee Osteoarthritis; Degenerative Arthritis Peripheral Joint; Failed Osteotomies; Failed Unicompartmental Replacement

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

JOURNEY II XR TKA

This is a single arm study, all subjects will receive JOURNEY II XR TKA

JOURNEY II XR Total Knee System

Intervention Type: DEVICE

JOURNEY II XR Total Knee System

Interventions

JOURNEY II XR Total Knee System

JOURNEY II XR Total Knee System

Intervention Type: DEVICE

Eligibility 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.).

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Loma Linda University Dept. of Orthopaedic Surgery

Loma Linda, California, United States

Holy Cross Orthopedic Institute

Fort Lauderdale, Florida, United States

Castle Orthopaedics & Sports Medicine, S.C.

Aurora, Illinois, United States

Midwest Orthopaedics at Rush

Chicago, Illinois, United States

Anne Arundel Medical Center

Annapolis, Maryland, United States

DeClaire LaMacchia Orthopaedic Institute

Rochester, Michigan, United States

Reno Orthopaedic Center

Reno, Nevada, United States

Mercer Bucks Orthopaedics

Hamilton, New Jersey, United States

NYU Hospital for Joint Diseases / NYU Langone Medical Center

New York, New York, United States

Hospital for Special Surgery

New York, New York, United States

Columbia University Center for Hip & Knee Replacement

New York, New York, United States

The Lindner Research Center at the Christ Hospital

Cincinnati, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Providence Regional Medical Center Everett

Everett, Washington, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 24249702 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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. doi: 10.1136/ard.2003.011742.

Reference Type: BACKGROUND

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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. doi: 10.2106/00004623-200406000-00031. No abstract available.

Reference Type: BACKGROUND

PMID: 15173310 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24792950 (View on PubMed)

Gidwani S, Fairbank A. The orthopaedic approach to managing osteoarthritis of the knee. BMJ. 2004 Nov 20;329(7476):1220-4. doi: 10.1136/bmj.329.7476.1220. No abstract available.

Reference Type: BACKGROUND

PMID: 15550426 (View on PubMed)

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. doi: 10.2106/00004623-200403000-00003.

Reference Type: BACKGROUND

PMID: 14996871 (View on PubMed)

Other Identifiers

U1111-1191-7751

Identifier Type: OTHER

Identifier Source: secondary_id

16-4049-06

Identifier Type: -

Identifier Source: org_study_id