Table 1.

Criteria for Enrollment.

Inclusion criteria
	Criteria
1	Bone density of the lumbar spine (L2–L4) measured using DEXA was <80% of the young adult mean or bone atrophy was assessed as Grade 1 or higher on lateral radiographs, and there was a painful acute compression fracture of one thoracic or lumbar vertebra (T5–L5). To confirm that all acute fractures were fresh fractures before enrollment, MRI was performed.
2	Vertebral height measured at the anterior border or the central part of the indicated vertebral body was decreased to 80% or lower of the mean of the most proximal normal (unfractured) vertebral bodies above and below the indicated vertebral body. Nevertheless, if the indicated vertebral body was the fifth lumbar vertebra (L5), the vertebral height measured at the anterior border or the central part of the indicated vertebral body had to be decreased to 80% or lower of the most proximal normal (unfractured) vertebral body above the indicated vertebral body.
3	No more than two fractured vertebral bodies other than the indicated vertebral body.
4	Low back pain was not relieved despite 3 months (12 weeks) of conservative therapy after onset (including patients for whom low back pain continued for at least 3 months [12 weeks] without treatment). The following patients who did not respond to conservative therapy were considered eligible even if the onset was within 3 months (12 weeks):
	a) Patients for whom conservative therapy could not be continued due to the pain that was not reduced by maximum medication (NRS ≥ 4).
	b) Patients for whom back bracing could not be continued.
	c) Patients who could not tolerate or had adverse reactions to analgesic medications.
5	NRS pain score of ≥4 for low back pain at screening.
6	Either gender.
7	Age ≥40 years and provision of written informed consent.
8	Treatment with SJ-11001-A and SJ-11001-B was deemed possible by the primary investigator/subinvestigator.
Exclusion criteria (patients meeting any of the following conditions were excluded)
1	Previous spinal surgery
2	Difficulty using SJ-11001-A and SJ-11001-B due to the status of the spinal fracture (e.g., the upper endplate of the indicated vertebral body was located below the pedicle).
3	Pedicle fracture of the indicated vertebral body.
4	Fracture of the posterior wall of the indicated vertebral body confirmed by X-ray, CT, or MRI.
5	Pre-existing (but unrelated to the fracture of the indicated vertebral body) abnormal neurological findings or radiculopathy with unstable symptoms.
6	Low back pain that was difficult to resolve due to causes other than the target disease.
7	Spinal fracture due to vertebral or spinal neoplastic disease or multiple myeloma.
8	Spinal fracture due to secondary osteoporosis.
9	Inability to withdraw anticoagulant therapy.
10	Systemic infection, local infection of a fractured vertebral body, or hemorrhagic diathesis.
11	Inability to tolerate general anesthesia.
12	History of hypersensitivity to bone cement (PMMA) or contrast agents.
13	Inability to complete a QOL survey due to dementia or other disorders.
14	Inability to walk or stand before the injury occurred (walking with assistance was permitted).
15	Contraindications to MRI.
16	Pregnancy or planning to become pregnant during the study period.
17	Current participation in another clinical trial or participation in another clinical trial in the past 3 months.
18	Contraindications to spinal reconstruction with internal fixation.
19	Known hypersensitivity to cobalt–chromium alloys.
20	Study participation deemed inappropriate by the primary investigator/subinvestigator.

CI, confidence interval; CT, computed tomography; DEXA, dual-energy X-ray absorptiometry; L, lumbar vertebra; MRI, magnetic resonance imaging; NRS, numerical rating scale; QOL, quality of life; T, thoracic vertebra; VB, vertebral body; vertebral body stenting