None listed
Conditions
Interventions
Medical Device : 1. with osteoporotic vertebral compression fractures requiring thoracolumbosacral orthosis bracing will be referred to this clinical trial. 2. Subjects who provide voluntary written i
subjects confirmed eligible based on the eligibility assessment may be fitted with the investigational orthosis immediately thereafter.
[Intervention Details]
? Experimental Group
Subjects randomized
Sponsors
Soon Chun Hyang University Hospital Seoul
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for participation in this clinical trial. Subject has provided written, signed, and dated informed consent prior to any study procedures. Subject is willing to comply with all study procedures for the duration of the study. Adult male or female aged 50 years or older. One to two vertebral compression fractures meeting all of the following criteria: Osteoporosis confirmed by bone mineral density (T-score < -1.0) Fracture located between T7 and L5 Acute fracture confirmed by MRI, or by bone scan or SPECT if MRI is not feasible Fracture sustained within 3 weeks (new/acute fracture)
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from this clinical trial. Active infection Severe or uncontrolled systemic disease Pathologic fracture associated with a mass within the spinal canal Neurologic injury due to the vertebral fracture Pregnant or lactating women Vertebral fracture requiring surgery due to high-energy trauma Pathologic fracture due to metastatic cancer, solitary cancer, hematologic malignancy, etc. Clinically unstable neurologic deficit Myelopathy or radiculopathy that makes conservative treatment difficult Body mass index (BMI) > 40 Serious cardiopulmonary disease Psychiatric disorder, mental retardation, or dementia that impairs communication Life expectancy shorter than the study duration Inability to ambulate prior to the acute fracture due to causes unrelated to the current injury Prior surgical history at the index level Any other condition that, in the investigator's judgment, makes participation ethically inappropriate or could affect the results of the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Oswestry Disability Index (ODI) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in 100mm Visual Analogue Scale (VAS) score for back pain;Change from baseline in vertebral body compression (collapse) on spinal X-ray | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Woo Choi
Soon Chun Hyang University Hospital Seoul
Outcome results
None listed