Vertebral Body Augmentation Clinical Trial
| NCT number | NCT01269359 |
| Other study ID # | BARZ-003HMO-CTIL |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | January 3, 2011 |
| Last updated | March 21, 2013 |
Modern orthopedic and spine surgeons strive towards minimizing surgical exposure and towards
increased precision in the placement of implants. This trend requires an increased use of
fluoroscopic guidance, which leads to increased exposure of the patient, surgeon and the
operating room staff to radiation.
Robotic assisted spine surgery is routinely performed in the authors' institution for a
variety of indications such as degenerative conditions, trauma, tumors , infections and
deformity correction11. The objective of this study is to compare the radiation exposure
time during robotic guided vertebral body augmentation to the published results for similar
surgeries.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Men and Women - Ages 18-85 Exclusion Criteria: - Unwillingness to participate the study |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hadassah Medical Organizaton | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | amount of radiation | amount of radiation is calculated from the DLP (Dose Length Product) | Yes |