NCT06670404 Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
| NCT ID | NCT06670404 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prof Nicolas Theumann |
| Condition | Vertebral Compression Fractures |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-11-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2024-11-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06670404 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vertebral Compression Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06670404 currently recruiting?
Yes, NCT06670404 is actively recruiting participants. Contact the research team at nicolas.theumann@hirslanden.ch for enrollment information.
Where is the NCT06670404 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT06670404 clinical trial?
NCT06670404 is sponsored by Prof Nicolas Theumann. The trial plans to enroll 130 participants.