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

JRCT ID: jRCT1050240107

Registered date:08/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Osteoporotic Vertebral Fractures
• Date of first enrollment: 08/08/2024
• Target sample size: 90
• Study type: Interventional
• Intervention(s): Patients with severe osteoporotic vertebral fractures are randomly allocated to vertebroplasty and posterior spinal fusion.

Outcome(s)

• Primary Outcome: Oswestry Dissability Index (ODI) 24 weeks after surgery
• Secondary Outcome: Incidence 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 maximum: Not applicable
• Gender: Both

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Takahashi Shinji