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Clinical Study on the Treatment of Osteoporotic Thoracolumbar Vertebral Fractures in the Elderly Using Bone Cement Filling Mesh Bag Technique

Clinical Study on the Treatment of Osteoporotic Thoracolumbar Vertebral Fractures in the Elderly Using Bone Cement Filling Mesh Bag Technique

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113559
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Geriatric osteoporotic thoracolumbar vertebral fractures

Interventions

Exposure group: Net technique:None
Non-exposure group: PKP technique:None

Sponsors

Shanghai First People's Hospital, South Branch - Trauma Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age > 60 years, with radiographic evidence (X-ray, CT, and MRI) of a significant compressive or burst fracture (T10-L2), loss of >50% of vertebral body height in the mid or anterior portion, and at least one intact pedicle in the injured vertebra. 2.Bone mineral density (BMD) T-score < -2.5 SD, as measured by dual-energy X-ray absorptiometry (DXA) at the hip or other vertebral bodies. 3.Presence of significant thoracolumbar pain, but without symptoms of nerve root compression. 4.Scheduled to undergo either percutaneous kyphoplasty (PKP) or the bone cement filling mesh bag technique as per the clinical treatment plan. 5.Provision of signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Age -2.5 SD, as measured by dual-energy X-ray absorptiometry (DXA) at the hip or other vertebral bodies. 4.Spinal canal encroachment > 20%, presence of severe neurological symptoms requiring surgical decompression. 5.Multiple comorbidities rendering the patient unfit to tolerate the surgical procedure.

Design outcomes

Primary

MeasureTime frame
the degree of improvement in the leakage;Vertebral height restoration rate;ODI score;

Secondary

MeasureTime frame
VAS score;

Countries

China

Contacts

Public ContactWang An

Shanghai First People's Hospital, South Branch - Trauma Center

dr_wangan@163.com+86 139 1824 4937

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026