No registrations found.
ID
Source
Health condition
painful osteoporotic vertebral fractures
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of cement leakage.
Secondary outcome
1. 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.
Background summary
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.
Study objective
High viscosity PMMA bone cement reduces the occurrence of cement leakage comprared to low viscosity PMMA bone cement.
Study design
Preoperative, 1, 4, 12, 26, 52 and 104 weeks.
Intervention
Percutaneous vertebroplasty with either high or low viscosity PMMA bone cement.
Orthopedic surgery<br>
P.O. box 9600
M.J. Nieuwenhuijse
Leiden 2300 RC
The Netherlands
+31 (0)71 5263795
M.J.Nieuwenhuijse@lumc.nl
Orthopedic surgery<br>
P.O. box 9600
M.J. Nieuwenhuijse
Leiden 2300 RC
The Netherlands
+31 (0)71 5263795
M.J.Nieuwenhuijse@lumc.nl
Inclusion criteria
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.
Exclusion criteria
Refusal of participation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3138 |
| NTR-old | NTR3282 |
| Other | METC LUMC : P10.055 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |