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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34964

Enrollment

Registered

2010-05-12

Start date

2010-12-01

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

"broken back" vertebral fractures

Interventions

PVP with usage of either conventional (low-medium) viscosity PMMA bone cement or high viscosity PMMA bone cement. The PVP-procedure is performed on a biplane angiography unit using conscious sedati

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Incidence of cement leakage per treated vertebra.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)