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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000048506
Receipt No. R000055273
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
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/28

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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