Facet Joint Arthropathy, Pathological Fracture, Vertebral Compression Fractures
Conditions
Keywords
vertebroplasty, CONFIDENCE High Viscosity Spinal Cement, observational post-market study
Brief summary
The purpose of this study is to collect clinical and radiographic outcomes in patients undergoing vertebroplasty procedures for the treatment of osteoporotic or pathological fractures of the vertebral body to understand the role of sagittal balance in patient outcomes. To support this objective, the sagittal balance measurement of sagittal vertical axis (SVA), NRS back pain, Quebec Back Pain Disability Scale (Quebec) score, and complications will be collected. The secondary purpose of the study is to review the role of sagittal balance and adjacent facet joint arthropathy treatment in patients with vertebral body fractures due to osteoporosis or tumor.
Interventions
DEVICEVertebroplasty
Vertebral compression fractures treated with CONFIDENCE High Viscosity Cement
Sponsors
Johnson & Johnson
Dr Danoob Dalili
Prof Nicolas Theumann
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>18 years. * Patients requiring vertebroplasty for the fixation of symptomatic pathological fractures of the thoracic or lumbar vertebral body resulting from osteoporosis or tumor. * Symptomatic vertebral compression fracture(s) confirmed by MRI with bone marrow oedema on T2/STIR sequences. * Diagnosis of osteoporosis (clinically and confirmed on DXA with quantifiable BMD) or pathological fracture due to tumor * Patients with 1 or more vertebral compression fractures of the thoracic or lumbar spine Note: Patients with a current vertebral compression fracture who also have a previous history of vertebral compression fractures of the thoracic or lumbar spine may be included. Study Specific Inclusion Criterion • Signed informed consent
Exclusion criteria
* Infection * Vertebral body collapse to less than 1/3 (33%) of original height * Vertebral plana (\>90% vertebral body collapse) * Spinal stenosis (retro pulsed fragments). * Unstable spine warranting surgical stabilization * Prophylactic treatment of any vertebrae with vertebroplasty * Irreversible life threating bleeding disorders * End stage kidney disease * Drug dependence (IVDU) * Pregnancy Study Specific Exclusion Criterion: • Unable or unwilling to follow the standard of care prescribed follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of sagittal balance | Up to 12 months post index surgery | measurement of sagittal vertical axis (SVA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Back Pain | Up to 12 months post index surgery | Measured as NRS scale for back pain |
| Quebec Score | 6-12 months post index surgery | Measured as the standard Quebec Score |
| Complications | Up to 12 months post-index surgery | — |
Countries
Switzerland
Contacts
Primary ContactNicolas Prof Theumann, Medical Doctor
Outcome results
None listed