Assessement of Vertebroplasty-related Cement Leakage

NCT04867577 | Unknown

• 1 other identifier: 202012233RIND
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Vertebral compression fracture is a common disorder in elderly patients. Vertebroplasty or surgical fixation are therefore commonly performed, in which bone cement is injected and help to provide additional support for unstable fracture to ease the pain. Cement leakage to paraspinal vein is very common and often taken as indicator of endpoint of the procedure. However, the leaked cement entering venous system can go to right heart and cause pulmonary embolism sometimes. The prevalence and pattern of this problem is largely unknown, especially subclinical condition. In this project, we intend to perform in vivo investigation of the cement distribution under different injection conditions. We also plan to conduct a clinical study to investigate the pattern, prevalence, and risk factor of cement venous leakage and pulmonary embolism. The study is a prospective cohort design, in which we plan to recruit 60 patients who receive vertebroplasty or cemented pedicle screws fixation for vertebral compression fracture. Plain X ray and computed tomography (CT) will be performed after operation. For CT, plain CT for operated site and dual energy acquisition for pulmonary vasculature will be performed, in which the pulmonary perfusion will be detected precisely. The different modalities can help delineate of radiological pattern of cement leakage. Spine surgeon, interventional radiologist, neuroradiologist, and thoracic radiologist will participate in this project. Experience on the optimal technique for cement use under fluoroscope is expected. The knowledge obtained in this study can be used in clinical ground and translate into academic outcome and clinical patient care.

Conditions

Vertebral Fracture

Keywords

vertebra

Outcome Measures

Primary Outcomes (1)

• prevalence of pulmonary embolism

  detection of cement pulmonary embolism on contrast enhanced dual energy CT

  6 months

Secondary Outcomes (1)

• prevalence of paraspinal venous leakage

  6 months

Study Arms (1)

vertebral osteoporotic compression fracture

Patients with osteoporotic vertebral compression receiving vertebroplasty or cemented screws reconstruction

Diagnostic Test: CT scan of lung and spine

Interventions

CT scan of lung and spine DIAGNOSTIC_TEST

Dual energy CT scan of thorax and spine

vertebral osteoporotic compression fracture

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with vertebral compression fracture requiring vertebroplasty or cemented transpedicular screws fixation

You may qualify if:

• vertebral compression fracture requiring vertebroplasty or cemented transpedicular screws fixation
• older than 20 year old

You may not qualify if:

• active infection
• progressive neurological deterioration,
• coagulopathy
• renal insufficiency (serum creatinine \> 1.5 mg/dL
• severe allergic reaction to contrast medium
• pregnant or breast-feeding women

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Yen-Heng Lin, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen-Heng Lin, MD

CONTACT

886-02-23123456; cryhungry@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: April 30, 2021
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: May 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)