UMIN-CTR Clinical Trial

Public title

A Prospective, Multicenter, Study to Evaluate the Safety and Effectiveness of the JOURNEY II XR Total Knee System with VERILAST Technology

Acronym

JOURNEY II XR with VERILAST in Japan

Scientific Title

A Prospective, Multicenter, Study to Evaluate the Safety and Effectiveness of the JOURNEY II XR Total Knee System with VERILAST Technology

Scientific Title:Acronym

JOURNEY II XR with VERILAST in Japan

Region

Japan

Condition

The subject components are indicated for total knee arthroplasty performed for rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, or failed unicompartmental replacement.

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to provide short-term safety and performance data on the JOURNEY II XR Total Knee System.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary objective of this study is to demonstrate the safety and performance of the JOURNEY II XR by evaluating implant survival rates.

Key secondary outcomes

The EuroQol Five Dimensions Questionnaire (EQ-5D-5L)
The Forgotten Joint Score-Knee (FJS-12)
The Knee injury and Osteoarthritis Outcome Scores (KOOS)
Radiographic outcomes
Range of Motion (RoM)
Adverse Events (AEs)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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. be an adult patient that in the judgement of the Investigator is 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
6. be patient with the JURNEY II XR Knee system as determined by the principal investigator, independent of this study, to be the best treatment for the patient, independent of this study

Key exclusion criteria

1. have any of the following conditions in the index joint:
a. Intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment
b. Significant varus or valgus deformities (>15 angle)
c. Incomplete or insufficient tissue surrounding the knee
d. Collateral ligament insufficiency
e. Inadequate bone stock to support the device (e.g., severe osteopenia/osteoporosis) or will require use of femoral and tibial stems
f. History of prior TKA
2. have any of the following conditions in the contralateral joint:
a. a previous TKA as a revision for a failed total or unicondylar knee arthroplasty
b. 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. a previous contralateral or ipsilateral revision hip arthroplasty
b. ipsilateral hip arthritis resulting in flexion contracture
c. 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. 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

Target sample size

106

Name of lead principal investigator

1st name	Osamu
Middle name
Last name	Nishiike

Organization

Kushiro Sanjikai Hospital

Division name

Orthopaedic Surgery

Zip code

0850836

Address

4-30, Nusamai-cho, Kushiro city, Hokkaido

TEL

0154-41-2299

Email

n.osamu@sanjikai.net

Name of contact person

1st name	Seigo
Middle name
Last name	Itoh

Organization

Smith & Nephew KK

Division name

Clinical Strategy and Operation

Zip code

1055114

Address

14th Floor, World Trade Center Building South Tower 2-4-1 Hamamatsucho, Minato-ku, Tokyo

TEL

03-5403-8811

Homepage URL

Email

seigo.itoh@smith-nephew.com

Institute

Smith & Nephew KK

Institute

Department

Personal name

Organization

Smith & Nephew KK

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kushiro Sanjikai Hospital Ethics Committee

Address

4-30 Shimaicho, Kushiro City, Hokkaido

Tel

0154-41-2299

Email

ikyoku@sanjikai.net

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

106

Results

Clinical success of the JOURNEY II XR Total Knee System met the primary objective as it is no worse than the 98% historical control with a margin of 7% (i.e. 91% non-inferiority limit), p=0.006.

Results date posted

2024

Year

03

Month

30

Day

Results Delayed

Delay expected

Results Delay Reason

When the analysis results were presented at a Investigator's meeting on 21st July, Investigators pointed out issues such as the coding of ROM values, X-ray image data, and names of adverse events, and data entry errors were confirmed at the sites. Due to the need to correct the CRFs, Unlock of DB, Re-lock, and re-analyze the database, there will be a delay from the initial publication timeline of the results. (As of September 21, 2023)

Date of the first journal publication of results

Baseline Characteristics

Overall, 94 subjects (106 knees) were enrolled, and the mean age of the subjects was 71.7 years old (SD = 6.8, range 46-83), with 3 subjects (3.2%) under 65 years old and 91 subjects (96.8%) over 65 years old. Regarding gender, 68 subjects (72.3%) were female and 26 subjects (27.7%) were male. Regarding Race/ Ethnicity, 93 subjects (98.9%) were Japanese and 1 subject (1.1%) was Asian. The primary diagnosis was osteoarthritis in 105 knees (99.1%) and rheumatoid arthritis in 1 knee (0.9%).

Participant flow

This study was a prospective, single-arm, multicenter, post-market clinical follow-up study to collect relevant clinical and radiological data from 106 knees/ 94 subjects (knees, as the study protocol allowed for a second to be enrolled) implanted with the JOURNEY II XR Total Knee System. The study did not utilize randomization or blinding procedures. Subjects enrolled into this study received a TKA as part of standard of care following a primary diagnosis of (1) rheumatoid arthritis, (2) post-traumatic arthritis, (3) osteoarthritis, (4) degenerative arthritis, (5) failed osteotomies, and/or (6) failed unicompartmental replacement. Subjects meeting all inclusion and no exclusion criteria for this study received the JOURNEY II XR device. Total study duration for study participants was two (2) years. Data was collected at Pre-op, Operative, Discharge, 3 and 6 months, 1 year and 2 year after the surgery. An interim analysis was not planned or performed for this study.
The breakdown of 10 knees/ 9 subjects excluded from the analysis were, Death: 1 knee/ 1 subject, Revision: 2 knees/ 2 subjects, and Lost to follow-up: 7 knees/ 6 subjects.

Adverse events

Ninety-four (94) subjects with 106 knees implanted were evaluable for safety. Thirty-one (31) AEs were reported from 23 (24.47%) subjects; 20 of the events were reported as not related to the study device or procedure; 24 events were serious in 18 subjects (including 1 death, not related to device/procedure). Majority of SAEs recovered/resolved with or without treatment.
There were 1 AE (1 subject) classification disagreement between Investigator assessed and Sponsor classified AEs resulting with a reclassification from 1 ADE (1 subject) to ASADE, and no change of classification to an unanticipated serious adverse device effect (USADE) that the Sponsor assessed as anticipated.
Of the 31 AEs reported, 20 were reported as not related to the study device or procedure. Including 1 death (LOSS OF BLOOD) reported as not related device/procedure. No other events that were reported as not related required subject discontinuation.
Study device related reporting totaled 6 events in 6 subjects (2 ADE in 2 subjects, 4 ASADE in 4 subjects). Two (2) of these events in 2 subjects were associated with a revision. These were the only device related events that required subject discontinuation from the study.
Study procedure related reporting totaled 5 events in 4 subjects (5 ASADE in 4 subjects). None of the procedure related events reported required subject discontinuation.
No device deficiencies were reported in the study.

Outcome measures

[Primary Efficacy Result]
- The study showed a 2-year survivorship of 94/96=97.9% (95% confidence interval 92.7, 99.8%).

[Secondary Efficacy Result]
- For EQ-VAS, at the pre-operative visit, the score had a mean of 62.0 (SD 20.7, range 10 - 95), by 2 year assessment increased to a mean of 83.7 (SD 13.8, range 28 - 100).
- For EQ Health Score, at the pre-operative visit, the score had a mean of 0.61 (SD 0.14, range 0.12 - 1), by 2 year assessment increased to a mean of 0.84 (SD 0.14, range 0.57 - 1).
- For FJS, at the 3 month visit, the score had a mean of 40.0 (SD 26.0, range 0 - 97.9), and by 2 year assessment increased to a mean of 65.4 (SD 25.9, range 10.4 - 100).
- For KOOS symptoms & stiffness, at the pre-operative visit, the score had a mean of 59.2 (SD 20.2, range 3.6 - 100), by 2 year assessment increased to a mean of 84.6 (SD 14.2, range 35.7 - 100).
- For radiolucent line, at the 3 month assessment 28 knees had presence within at least one of zone 1-21, the total length of radiolucent line (per knee) had a mean of 5.1mm (SD 6.7, 1 - 29mm range), at the 2 year assessment 35 knees had presence of radiolucent lines within at least one of zone 1-21, the total length of radiolucent line (per knee) had a mean of 2.6mm (SD 2.3, 1 - 11mm range).
- Flexion had a mean of 135.0 degree (SD 10.3, range 108 - 161 degree) at pre-operative, and at 2 years had a mean of 130.3 degree (SD 11.4, range 90 - 152 degree).
- Extension had a mean of 4.0 degree (SD 6.0, range -1 - 23 degree) at pre-operative, and at 2 years had a mean of 1.5 degree (SD 3.0, range 0 - 12 degree).
- Total range of motion had a mean of 130.9 degree (SD 12.3, range 98 - 161 degree) at pre-operative, and at 2 years had a mean of 128.8 degree (SD 11.9, range 90 - 152 degree).
- For adverse events, refer to above.

Plan to share IPD

IPD sharing Plan description

There is no IPD sharing plan.

Recruitment status

No longer recruiting

Date of protocol fixation

2018

Year

09

Month

03

Day

Date of IRB

2018

Year

11

Month

13

Day

Anticipated trial start date

2018

Year

11

Month

15

Day

Last follow-up date

2023

Year

02

Month

20

Day

Date of closure to data entry

2023

Year

09

Month

30

Day

Date trial data considered complete

2023

Year

10

Month

03

Day

Date analysis concluded

2024

Year

01

Month

09

Day

Other related information

Prospective, Multicenter, Post-market Clinical Follow-Up, Single-Arm Study
Effectiveness information, subject satisfaction, and quality of life will be measured.

Registered date

2018

Year

09

Month

05

Day

Last modified on

2024

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038421