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A randomized controlled study to evaluate the safety and efficacy of acute thoracolumbar osteoporosis vertebral fracture classification

A randomized controlled study to evaluate the safety and efficacy of acute thoracolumbar osteoporosis vertebral fracture classification

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029396
Enrollment
Unknown
Registered
2020-01-29
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-02-03

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

Conditions

acute thoracolumbar osteoporosis vertebral fracture

Interventions

experimental group:Directional injection of bone cement
control group:Conventional injection of bone cement

Sponsors

Honghui Hospital Affiliated to Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Acute thoracolumbar osteoporosis vertebral fracture; 2) OTLICS is greater than 4 points; 3) The diagnosis, OTLICS and classification were based on symptoms, X-ray, CT, MRI and dual energy X-ray bone mineral density; 4) more than 60 years old.

Exclusion criteria

Exclusion criteria: 1) Simultaneous fracture of multiple vertebrae (more than or equal to 2 vertebrae); 2) Combined with neurological symptoms; 3) Intolerable to general anesthesia or / and local anesthesia; 4) Contraindications of PKP and PVP; 5) Patients with hematopoiesis cancer or serious blood diseases; 6) The patient has a history of mental, developmental and psychological diseases; 7) History of alcohol or drug abuse; 8) The patient is unable to take blood from the vein; 9) Patients refused to participate in the study.

Design outcomes

Primary

MeasureTime frame
Vertebral compression ratio;Cobb's angle;visual analogue scale, VAS;Oswestry disability index,ODI;SF-36;Mortality during follow-up;

Secondary

MeasureTime frame
mFI;Re-fracture rate;Injection volume of bone cement;X-ray exposure time;Operative time;Blood loss;bone mineral density,BMD;

Countries

China

Contacts

Public ContactDingjun Hao

Honghui Hospital Affiliated to Xi'an Jiaotong University

zjnllsy@126.com+86 13909297839

Outcome results

None listed

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