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NCT04867577
Assessement of Vertebroplasty-related Cement Leakage
trial testing CT scan of lung and spine in Vertebral Fracture in 60 participants. Status unknown.
29 March 2022
Quick facts
| Lead sponsor | National Taiwan University Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 30 April 2021 |
| Primary completion | 29 March 2022 |
| Estimated completion | 29 March 2022 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- CT scan of lung and spine
Conditions studied
- Vertebral Fracture — all drugs for Vertebral Fracture →
Sponsor
National Taiwan University Hospital
Who can join
20 and older, any sex, with Vertebral Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04867577
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04867577 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Taiwan University Hospital
- Last refreshed: 6 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04867577.
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