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Rheumatoid Vasculitis With Rheumatoid Arthritis of KneeNCT03136887

JOURNEY II XR Safety and Effectiveness PMCF

An observational study of Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee and Unilateral Post-Traumatic Osteoarthritis of Knee, run by Smith & Nephew, Inc. at 14 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 to 75 years
What is being tested?
JOURNEY II XR Total Knee System
Type of treatment
Medical device
How many people
176 participants
Where
14 sitesUnited States
Study dates
28 Jul 2017to Apr 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients will be selected from their orthopedic surgeons practice.

Who may be able to join

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

Who cannot join

  • 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
Show all 25Show fewer
  • History of prior TKA
  • 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
  • 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
  • have a diagnosis of an immunosuppressive disorder
  • have an active infection, treated or untreated, systemic or at the site of the planned surgery
  • 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
  • have a BMI > 40
  • be facing current or impending incarceration
  • have a known allergy to study device or one or more of its components
  • be pregnant or have plans to become pregnant during the course of the study
  • 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
  • be enrolled in another drug, biologic, or device study within 30 days of screening
  • be known to be at risk for lost to follow-up or failure to return for scheduled visits
  • during the surgery, have a cruciate ligament tibial bone island that is secured with any fixative device (e.g. screw, plate, etc.).

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Castle Orthopaedics & Sports Medicine, S.C.

    Aurora, Illinois, 60504

  • Midwest Orthopaedics at Rush

    Chicago, Illinois, 60612

  • The Lindner Research Center at the Christ Hospital

    Cincinnati, Ohio, 45219

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201

  • Holy Cross Orthopedic Institute

    Fort Lauderdale, Florida, 33334

  • Mercer Bucks Orthopaedics

    Hamilton, New Jersey, 08691

  • Loma Linda University Dept. of Orthopaedic Surgery

    Loma Linda, California, 92354

  • NYU Hospital for Joint Diseases / NYU Langone Medical Center

    New York, New York, 10003

  • Hospital for Special Surgery

    New York, New York, 10021

  • Columbia University Center for Hip & Knee Replacement

    New York, New York, 10032

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Reno Orthopaedic Center

    Reno, Nevada, 89503

  • DeClaire LaMacchia Orthopaedic Institute

    Rochester, Michigan, 48307

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
JOURNEY II XR Total Knee System
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JOURNEY II XR Total Knee SystemDevice

    JOURNEY II XR Total Knee System

Study groups in NCT03136887
Study groupRoleWhat they receive
JOURNEY II XR TKAThis is a single arm study, all subjects will receive JOURNEY II XR TKA
Receives: Device: JOURNEY II XR Total Knee System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant survival rate

    Did knee survive with no revision through 10 years

    Measured: 10 years

Secondary outcomes (10)

  1. Knee function

    Lateral Step-Up Test

    Measured: 10 years

  2. Quality of Life - EQ-5D - 3L

    Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire

    Measured: 10 years

  3. Quality of Life - FJS

    Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire

    Measured: 10 years

  4. Quality of Life - KOOS

    Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS) questionnaire

    Measured: 10 years

  5. Quality of Life - ABC scale

    Patient Reported Outcomes using Activities-specific Balance Confidence (ABC) questionnaire

    Measured: 10 years

  6. Quality of Life - SAPSS

    Patient Reported Outcomes using Self-Administered Patient Satisfaction Score (SAPSS) questionnaire

    Measured: 10 years

  7. Physiotherapy (PT) utilization - No. of visits

    Number of PT visits required up to 6 months after surgery

    Measured: 6 Months Post-operatively

  8. Physiotherapy (PT) utilization - Period of visits

    Time period during which PT appointments are required up to 6 months after surgery

    Measured: 6 Months Post-operatively

  9. Radiographic outcomes

    X-rays of index joint

    Measured: 10 years

  10. Adverse Events (AEs)

    All AEs will be collected and reported

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2017
  2. Study start28 Jul 2017
  3. Primary completionApr 2029 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03136887
Sponsor's protocol ID
16-4049-06
Other IDs
U1111-1191-7751
Status last verified
Aug 2024
First submitted
25 Jan 2017
Last updated
12 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 24249702

  • 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.

    PubMed 22398175

  • 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. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27.

    PubMed 17719803

  • 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. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available.

    PubMed 11014340

  • 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.

    PubMed 14644851

  • 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.

    PubMed 15173310

  • 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.

    PubMed 24792950

  • 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.

    PubMed 15550426

  • 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.

    PubMed 14996871

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee and Unilateral Post-Traumatic Osteoarthritis of Knee, run by Smith & Nephew, Inc. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant survival rate (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03136887, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.

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