JOURNEY II XR Safety and Effectiveness PMCF

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03136887
• Other study ID #: 16-4049-06
• Secondary ID: U1111-1191-7751
• Status: Active, not recruiting
• Start date: July 28, 2017
• Est. completion date: April 2029

Study information

• Verified date: January 2024
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 176
• Est. completion date: April 2029
• Est. primary completion date: April 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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.).

Related Conditions & MeSH terms

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

Intervention

Device:
• JOURNEY II XR Total Knee System
JOURNEY II XR Total Knee System

Locations

Country	Name	City	State
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Castle Orthopaedics & Sports Medicine, S.C.	Aurora	Illinois
United States	Midwest Orthopaedics at Rush	Chicago	Illinois
United States	The Lindner Research Center at the Christ Hospital	Cincinnati	Ohio
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Holy Cross Orthopedic Institute	Fort Lauderdale	Florida
United States	Mercer Bucks Orthopaedics	Hamilton	New Jersey
United States	Loma Linda University Dept. of Orthopaedic Surgery	Loma Linda	California
United States	Columbia University Center for Hip & Knee Replacement	New York	New York
United States	Hospital for Special Surgery	New York	New York
United States	NYU Hospital for Joint Diseases / NYU Langone Medical Center	New York	New York
United States	Oregon Health & Science University	Portland	Oregon
United States	Reno Orthopaedic Center	Reno	Nevada
United States	DeClaire LaMacchia Orthopaedic Institute	Rochester	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival rate	Did knee survive with no revision through 10 years	10 years
Secondary	Knee function	Lateral Step-Up Test	10 years
Secondary	Quality of Life - EQ-5D - 3L	Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire	10 years
Secondary	Quality of Life - FJS	Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire	10 years
Secondary	Quality of Life - KOOS	Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS) questionnaire	10 years
Secondary	Quality of Life - ABC scale	Patient Reported Outcomes using Activities-specific Balance Confidence (ABC) questionnaire	10 years
Secondary	Quality of Life - SAPSS	Patient Reported Outcomes using Self-Administered Patient Satisfaction Score (SAPSS) questionnaire	10 years
Secondary	Physiotherapy (PT) utilization - No. of visits	Number of PT visits required up to 6 months after surgery	6 Months Post-operatively
Secondary	Physiotherapy (PT) utilization - Period of visits	Time period during which PT appointments are required up to 6 months after surgery	6 Months Post-operatively
Secondary	Radiographic outcomes	X-rays of index joint	10 years
Secondary	Adverse Events (AEs)	All AEs will be collected and reported	10 years