Clinical trial NCT03136887: JOURNEY II XR Safety and Effectiveness PMCF
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-02
Enrollment: 176
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from their orthopedic surgeons practice.

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.

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.).

Primary outcomes:
measure: Implant survival rate
timeFrame: 10 years
Secondary outcomes:
measure: Knee function
timeFrame: 10 years
measure: Quality of Life - EQ-5D - 3L
timeFrame: 10 years
measure: Quality of Life - FJS
timeFrame: 10 years
measure: Quality of Life - KOOS
timeFrame: 10 years
measure: Quality of Life - ABC scale
timeFrame: 10 years
measure: Quality of Life - SAPSS
timeFrame: 10 years
measure: Physiotherapy (PT) utilization - No. of visits
timeFrame: 6 Months Post-operatively
measure: Physiotherapy (PT) utilization - Period of visits
timeFrame: 6 Months Post-operatively
measure: Radiographic outcomes
timeFrame: 10 years
measure: Adverse Events (AEs)
timeFrame: 10 years
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Dept. of Orthopaedic Surgery
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Orthopedic Institute
state: Florida
city: Aurora
country: United States
facility: Castle Orthopaedics & Sports Medicine, S.C.
state: Illinois
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush
state: Illinois
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Rochester
country: United States
facility: DeClaire LaMacchia Orthopaedic Institute
state: Michigan
city: Reno
country: United States
facility: Reno Orthopaedic Center
state: Nevada
city: Hamilton
country: United States
facility: Mercer Bucks Orthopaedics
state: New Jersey
city: New York
country: United States
facility: NYU Hospital for Joint Diseases / NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Columbia University Center for Hip & Knee Replacement
state: New York
city: Cincinnati
country: United States
facility: The Lindner Research Center at the Christ Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.