Viscosity of PMMA Bone Cement in Percutaneous Vertebroplasty for Osteoporotic Vertebral Compression Fractures: A Randomized Controlled Trial

Phase 4

Completed

Conditions: broken back
vertebral fractures
10052547
10017322
10009720

Registration Number: NL-OMON34964

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 86

Inclusion Criteria

(I) Presence of an Osteoporotic VCF, (II) focal back pain in the midline refractive to at least eight weeks of appropriate conservative treatment, (III) back pain related to the location of the VCF on radiography, (IV) the presence of bone marrow edema on MRI T2-weighted short tau inversion recovery (STIR) sequences in the corresponding collapsed VB, (V) age over 40 years and (VI) written informed consent.

Exclusion Criteria

(I) VCFs due to other causes than osteoporosis, (II) spinal cord compression or stenosis of the vertebral canal > 30% of the local canal diameter, (III) neurological deficits, (IV) incorrectable bleeding disorders, (V) infections related to the vertebral column, (VI) inability to lie prone for two hours, (VI) an American Society of Anesthesiologists (ASA)-score >= 4

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of cement leakage per treated vertebra.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> * Incidence and clinical relevance of pulmonary and cardiac<br /><br>cement emboli. The association between emboli and (type of)detected<br /><br>(local) cement leakage will be assessed.<br /><br>* Incidence of new (adjacent) OVCFs during the first year after<br /><br>PVP. The association between new OVCFs and (type of) detected<br /><br>cement leakage will be assessed.<br /><br>* Sensitivity and specificity of conventional radiography of<br /><br>the thoracic region in detection of cement leakage compared to CT-<br /><br>scanning of this region (gold standard).</p><br>