NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1050240107

Registered date:08/08/2024

Vertebral Augumentation versus Posterior Spinal Fusion for Severe Osteoporotic Vertebral Fractures: A Multicenter Randomized Controlled Trial

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedOsteoporotic Vertebral Fractures
Date of first enrollment08/08/2024
Target sample size90
Countries of recruitment
Study typeInterventional
Intervention(s)Patients with severe osteoporotic vertebral fractures are randomly allocated to vertebroplasty and posterior spinal fusion.

Outcome(s)

Primary OutcomeOswestry Dissability Index (ODI) 24 weeks after surgery
Secondary OutcomeIncidence of complications, Spinal alignment, Clinical outcomes such as EQ5D-5L, visual analog scale and surgical satisfaction

Key inclusion & exclusion criteria

Age minimum>= 65age old
Age maximumNot applicable
GenderBoth
Include criteria1. Patients diagnosed with osteoporotic vertebral fractures (OVF) using X-ray, MRI, or CT from the date of jRCT registration until March 2028. 2. Patients with OVF who visited Osaka Metropolitan University Hospital or participating institutions. 3. Patients aged 65 or older at the time of consent. 4. Patients with fresh OVF within 2 months of injury. 5. Patients with severe low back pain (VAS >= 40). 6. Patients with OVF between T10 and L2 levels. 7. Patients who have poor prognostic factors with conservative treatment (e.g., cases with confined high signal intensity areas or diffused low signal intensity areas in the fractured vertebra on T2-weighted MR images, or cases with endplate injury on both sides). 8. Patients with severe mobility of the fractured vertebra (vertebral motion angle >= 14 degrees) or patients with endplate injury on both sides.
Exclude criteria1. Patients who injured by high-energy trauma. 2. Patients with OVF unsuitable for vertebroplasty, such as those with diffuse idiopathic skeletal hyperostosis or ankylosing spondylitis. 3. Patients with stable OVF (vertebral motion angle < 14 degrees) or without endplate injury on both sides, for whom posterior fusion surgery is not indicated. 4. Patients with neurological deficits due to OVF. 5. Patients suspected of pathological fractures (e.g., OVF due to metastatic spinal tumors or pyogenic spondylitis). 6. Patients diagnosed with dementia. 7. Patients treated for psychiatric disorders, including those with strong psychosocial factors. 8. Patients treated for neurological disorders such as Parkinson's disease. 9. Patients seemed unsuitable for participation in the study by the primary physicians.

Related Information

Contact

Public contact
Name Shinji Takahashi
Address 1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Osaka, Japan Osaka Japan 545-8585
Telephone +81-6-6645-3851
E-mail stakahashi@omu.ac.jp
Affiliation Osaka Metropolitan University Graduate School of Medicine, Department of Orthopaedic Surgery
Scientific contact
Name Shinji Takahashi
Address 1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Osaka, Japan Osaka Japan 545-8585
Telephone +81-6-6645-3851
E-mail stakahashi@omu.ac.jp
Affiliation Osaka Metropolitan University Graduate School of Medicine, Department of Orthopaedic Surgery