High viscosity PMMA bone cement reduces the occurrence of cement leakage comprared to low viscosity PMMA bone cement.
ID
Bron
Aandoening
painful osteoporotic vertebral fractures
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Incidence of cement leakage.
Achtergrond van het onderzoek
Percutaneous 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.
Doel van het onderzoek
High viscosity PMMA bone cement reduces the occurrence of cement leakage comprared to low viscosity PMMA bone cement.
Onderzoeksopzet
Preoperative, 1, 4, 12, 26, 52 and 104 weeks.
Onderzoeksproduct en/of interventie
Percutaneous vertebroplasty with either high or low viscosity PMMA bone cement.
Publiek
Orthopedic surgery<br>
P.O. box 9600
M.J. Nieuwenhuijse
Leiden 2300 RC
The Netherlands
+31 (0)71 5263795
M.J.Nieuwenhuijse@lumc.nl
Wetenschappelijk
Orthopedic surgery<br>
P.O. box 9600
M.J. Nieuwenhuijse
Leiden 2300 RC
The Netherlands
+31 (0)71 5263795
M.J.Nieuwenhuijse@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Refusal of participation.
Opzet
Deelname
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In overige registers
Register | ID |
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NTR-new | NL3138 |
NTR-old | NTR3282 |
Ander register | METC LUMC : P10.055 |
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