Actively Recruiting
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Led by Prof Nicolas Theumann · Updated on 2025-02-17
130
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
Sponsors
P
Prof Nicolas Theumann
Lead Sponsor
J
Johnson & Johnson
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Patients needing vertebroplasty for symptomatic pathological fractures of the thoracic or lumbar vertebral body caused by osteoporosis or tumors
- Symptomatic vertebral compression fractures confirmed by MRI with bone marrow edema on T2/STIR sequences
- Diagnosis of osteoporosis confirmed clinically and by DXA with measurable bone mineral density or pathological fracture due to tumor
- Patients with one or more vertebral compression fractures of the thoracic or lumbar spine, including those with previous fractures
- Signed informed consent
You will not qualify if you...
- Infection
- Vertebral body collapse to less than one-third (33%) of original height
- Vertebral plana (over 90% vertebral body collapse)
- Spinal stenosis with retro pulsed fragments
- Unstable spine that requires surgical stabilization
- Prophylactic vertebroplasty treatment of any vertebrae
- Irreversible life-threatening bleeding disorders
- End-stage kidney disease
- Intravenous drug use dependence
- Pregnancy
- Unable or unwilling to follow prescribed follow-up visits
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clinique Bois Cerf
Lausanne, Switzerland
Actively Recruiting
Research Team
N
Nicolas Prof Theumann, Medical Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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