UMIN-CTR Clinical Trial

Basic information
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
Condition	Patients with acute spinal compression fracture due to primary osteoporosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Johnson and Johnson K.K. Medical Company
Institute
Department

Funding Source
Organization	Johnson and Johnson K.K. Medical Company
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 08 Month 01 Day

Related information
URL releasing protocol	NA
Publication of results	Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date	2022 Year 07 Month 29 Day
Last modified on	2022 Year 07 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055273