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

Vertebral Augmentation versus Posterior Spinal Fusion for Severe Osteoporotic Vertebral Fractures: A Multicenter Randomized Controlled Trial - VERSUS study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1050240107

Enrollment

Registered

2024-08-08

Start date

2024-09-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporotic Vertebral Fractures Osteoporotic Vertebral Fracture, Osteoporosis, Vertebral Fracture

Interventions

Patients with severe osteoporotic vertebral fractures are randomly allocated to vertebroplasty and posterior spinal fusion.

C000599360

Randomized Controlled Trial, Vertebroplasty, Posterior Spinal Fusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Oswestry Dissability Index (ODI) 24 weeks after surgery	—

Secondary

Measure	Time frame
Incidence of complications, Spinal alignment, Clinical outcomes such as EQ5D-5L, visual analog scale and surgical satisfaction	—

Contacts

Public ContactShinji Takahashi

Osaka Metropolitan University Graduate School of Medicine, Department of Orthopaedic Surgery

stakahashi@omu.ac.jp+81-6-6645-3851

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026