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PMMA bone cement viscosity in vertebroplasty.


- candidate number11124
- NTR NumberNTR3282
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-feb-2012
- Secondary IDsP10.055 METC LUMC
- Public TitlePMMA bone cement viscosity in vertebroplasty.
- Scientific TitleViscosity of PMMA Bone Cement in Percutaneous Vertebroplasty for Osteoporotic Vertebral Compression Fractures: A Randomized Controlled Trial.
- ACRONYM
- hypothesisHigh viscosity PMMA bone cement reduces the occurrence of cement leakage comprared to low viscosity PMMA bone cement.
- Healt Condition(s) or Problem(s) studiedPainful osteoporotic vertebral fractures
- Inclusion criteriaAll consecutive patients with one or more osteoporotic vertebral compression fractures attending our clinic and considered suitable candidates for PVP will be asked to take participate in this study.
- Exclusion criteriaRefusal of participation.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-jan-2014
- Target number of participants86
- InterventionsPercutaneous vertebroplasty with either high or low viscosity PMMA bone cement.
- Primary outcomeIncidence of cement leakage.
- Secondary outcome1. Incidence and clinical relevance of pulmonary and cardiac cement emboli;
2. Incidence of new (adjacent) OVCFs during the first year after PVP;
3. Postoperative pain and health-related quality of Life.
- TimepointsPreoperative, 1, 4, 12, 26, 52 and 104 weeks.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. M.J. Nieuwenhuijse
- CONTACT for SCIENTIFIC QUERIESMD. M.J. Nieuwenhuijse
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryPercutaneous VertebroPlasty (PVP), the percutaneous injection of acrylic bone cement in a fractured vertebral body, is nowadays a generally accepted treatment modality in painful osteoporotic vertebral compression fractures. Methods to reduce complications, like cement leakage and its sequelae such as pulmonary cement emboli and new vertebral fractures, should be explored in order to improve patient safety. Viscosity of bone cement is one crucial parameters which influence the occurrence of cement leakage, the interdigitation of the bone cement with the trabecular bone and the spatial distribution of the cement inside the fractured vertebral body, and hence the clinical outcome after PVP. To what extent, however, is currently unknown and will be determined in this single-blinded, randomized, controlled trial comparing PVP with either a low or a high viscosity bone cement in the treatment of painful osteoporotic vertebral fractures.
- Main changes (audit trail)
- RECORD14-feb-2012 - 2-mrt-2012


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