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
Conditions the study is for: Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee, Unilateral Post-Traumatic Osteoarthritis of Knee, Knee Osteoarthritis
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

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

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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.

City, postcode or hospital

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

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.

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
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 group	Role	What they receive
JOURNEY II XR TKA		This 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.

Implant survival rate
Did knee survive with no revision through 10 years
Measured: 10 years

Secondary outcomes (10)

Knee function
Lateral Step-Up Test
Measured: 10 years
Quality of Life - EQ-5D - 3L
Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire
Measured: 10 years
Quality of Life - FJS
Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire
Measured: 10 years
Quality of Life - KOOS
Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS) questionnaire
Measured: 10 years
Quality of Life - ABC scale
Patient Reported Outcomes using Activities-specific Balance Confidence (ABC) questionnaire
Measured: 10 years
Quality of Life - SAPSS
Patient Reported Outcomes using Self-Administered Patient Satisfaction Score (SAPSS) questionnaire
Measured: 10 years
Physiotherapy (PT) utilization - No. of visits
Number of PT visits required up to 6 months after surgery
Measured: 6 Months Post-operatively
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
Radiographic outcomes
X-rays of index joint
Measured: 10 years
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.

28 Jul 2017Apr 2029

First posted2 May 2017
Study start28 Jul 2017
Primary completionApr 2029 (estimated)
Study completionApr 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Rheumatoid Vasculitis With Rheumatoid Arthritis of KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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