UMIN-CTR Clinical Trial

Public title

A Multicenter Study to Evaluate the Safety and Effectiveness of SJ-11001-A and SJ-11001-B against Acute Spinal Compression Fracture Due to Primary Osteoporosis

Acronym

SJ-11001

Scientific Title

A Multicenter Study to Evaluate the Safety and Effectiveness of SJ-11001-A and SJ-11001-B against Acute Spinal Compression Fracture Due to Primary Osteoporosis

Scientific Title:Acronym

SJ-11001

Region

Japan

Condition

Patients with acute spinal compression fracture due to primary osteoporosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety and effectiveness of SJ-11001-A and SJ-11001-B in patients with acute spinal compression fracture due to primary osteoporosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1) Restoration rate of vertebral height measured using standing or sitting X-ray images from immediately before to 1 month after procedure
2) Changes in the degree of low back pain based on the NRS pain scores at screening and 7 days after procedure

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Balloon-expanding stent for vertebral body and bone cement

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

40

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients in whom bone density of the lumbar spine (L2-L4) measured by DEXA is less than 80% of YAM or bone atrophy is assessed as Grade 1 or higher by lateral X-ray views and who have painful acute spinal compression fracture in one thoracic or lumbar vertebra: the fifth thoracic vertebra to the fifth lumbar vertebra (T5-L5). As a condition of acute fracture, it has to be confirmed to be fresh fracture by MRI prior to enrollment.
(2) The vertebral height measured at the anterior border part or the central part of the indicated vertebral body has to be decreased to 80% or lower of the mean of the most proximal normal (unfractured) vertebral bodies above and below the indicated vertebra body.
(3) Patients with the number of fractured vertebral body other than the indicated vertebral body is not more than two.
(4) Patients in whom low back pain has not been relieved despite 3 months (12 weeks) of conservative therapy after the onset [including patients in whom low back pain has continued for at least 3 months (12 weeks) with or without treatment]. The following patients who do not respond to conservative therapy are considered eligible even if the onset was within 3 months (12 weeks).
(5) Patients in whom the NRS pain score is 4 or higher for low back pain at screening.
(6) Patients aged 40 years or older from whom written consent can be obtained.

Key exclusion criteria

(1) Patients with any previous spinal surgery.
(2) Patients with spinal fracture that prevents use of the study device.
(3) Patients with pedicle fracture of the indicated vertebral body.
(4) Patients with fracture of the posterior wall of the indicated vertebral body, which has been confirmed by X-ray, CT or MRI.
(5) Patients with pre-existing neurological abnormal findings.
(6) Patients with neurologic symptoms due to spinal cord compression or spinal canal stenosis requiring decompression.
(7) Patients with low back pain that is difficult to resolve due to causes other than the target disease.
(8) Patients with spinal fracture due to vertebral or spinal neoplastic disease or multiple myeloma.
(9) Patients with spinal fracture due to secondary osteoporosis.
(10) Patients in whom anticoagulant therapy cannot be withdrawn.
(11) Patients with systemic infection, local infection of fractured vertebral body, hemorrhagic diathesis.
(12) Patients to whom general anesthesia is inappropriate.
(13) Patients with a previous history of hypersensitivity to bone cement (PMMA) or contrast agents.
(14) Patients in whom a QOL survey is difficult due to dementia or other disorders.
(15) Patients incapable of walking or standing before injury.
(16) Patients in whom MRI is contraindicated.
(17) Patients who are pregnant or plan to become pregnant during the study period.
(18) Patients in whom spinal reconstruction with internal fixation cannot be indicated.
(19) Patients with known hypersensitivity to cobalt-chromium alloy.

Target sample size

87

Name of lead principal investigator

1st name	Ryuichi
Middle name
Last name	Takemasa

Organization

Kochi Medical School Hospital

Division name

Department of Orthopaedic Surgery

Zip code

783-0043

Address

185-1 Kohasu, Oko-cho, Nankoku-shi, Kochi, Japan

TEL

088-866-5811

Email

takemasar@yahoo.co.jp

Name of contact person

1st name	Kumiko
Middle name
Last name	Yagi

Organization

Johnson and Johnson K.K. Medical Company

Division name

Clinical Research

Zip code

101-0065

Address

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo, Japan

TEL

03-4411-6789

Homepage URL

Email

kyagi1@its.jnj.com

Institute

Johnson and Johnson K.K. Medical Company

Institute

Department

Personal name

Organization

Johnson and Johnson K.K. Medical Company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kochi Medical School Hospital IRB

Address

185-1 Kohasu, Oko-cho, Nankoku-shi, Kochi, Japan

Tel

088-880-2627

Email

im67@kochi-u.ac.jp

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

2022

Year

08

Month

01

Day

URL releasing protocol

NA

Publication of results

Unpublished

URL related to results and publications

NA

Number of participants that the trial has enrolled

89

Results

The restoration rates of vertebral height at 1 month after procedure (anterior and central part) were 31.671 +/- 26.462% and 31.835 +/- 24.622%, indicating the clinically significant restoration rate.

The change in NRS pain score was - 4.5 +/- 2.4 at 7 days after operation showing a significant change from screening, indicating the clinically significant decrease.

Results date posted

2022

Year

07

Month

28

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Gender: 25 male (28.4%) and 63 female (71.6%).
Age: the mean age was 77.4+/- 8.3 years old.

Participant flow

Agreement was obtained from 97 patients and among them, 89 subjects were enrolled and 8 subjects were not enrolled in the study. Among the enrolled subjects, 88 subjects were operated.

Adverse events

Adverse events of which relationship with malfunction cannot be denied developed in 18 subjects (20.5%, 19 cases) and among them, adverse events of which relationship with malfunction of SJ-11001-A cannot be denied was 17 subjects (19.3%, 18 cases) and adverse events of which relationship with malfunction of SJ-11001-B cannot be denied was 18 subjects (20.5%, 19 cases).

Outcome measures

The restoration rates of vertebral height at 1 month after procedure (anterior and central part) were 31.671+/-26.462% and 31.835+/-24.622%, and corresponding one-sided 95% confidence intervals (lower limits) for mean values were 26.778% and 27.194%. They were exceeded 20%, predefined criterion, indicating the clinically significant restoration rate.

The change in NRS pain score was - 4.5 +/- 2.4 at 7 days after operation showing a significant change from screening. In addition, the one-sided 95% confidence interval (upper limit) for mean value of changes at 7 days after operation was - 4.0, and this was below - 2.0, predefined criterion, indicating the clinically significant decrease.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2011

Year

10

Month

28

Day

Date of IRB

2012

Year

03

Month

26

Day

Anticipated trial start date

2012

Year

05

Month

21

Day

Last follow-up date

2015

Year

03

Month

23

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

07

Month

29

Day

Last modified on

2022

Year

07

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055273