Actively Recruiting
PROTECT - 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
N/A
Total Duration
On this page
Sponsors
P
Prof Nicolas Theumann
Lead Sponsor
J
Johnson & Johnson
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating clinical and radiographic outcomes in patients undergoing vertebroplasty to treat osteoporotic or pathological fractures of the vertebral body. The study aims to understand how sagittal balance affects patient outcomes. It will also examine the role of sagittal balance and adjacent facet joint arthropathy treatment in patients with vertebral fractures caused by osteoporosis or tumors. Participants will receive vertebroplasty treatment using CONFIDENCE High Viscosity Cement to fix vertebral compression fractures. This is an observational study involving patients with symptomatic pathological fractures of the thoracic or lumbar spine. Patients will be followed to assess their sagittal vertical axis (SVA), back pain levels, Quebec Back Pain Disability scores, and any complications after the procedure. During the study, participants will have their sagittal balance, pain, disability, and complications monitored for up to 12 months after surgery. Data will be collected through clinical and imaging assessments, including MRI confirmation of fractures. Researchers will track changes in sagittal balance and patient-reported outcomes over time to better understand treatment effects and patient recovery.
CONDITIONS
Brief 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 requiring vertebroplasty for symptomatic pathological fractures of the thoracic or lumbar vertebral body due to osteoporosis or tumor
- 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
- Signed informed consent
You will not qualify if you...
- Infection
- Vertebral body collapse to less than one-third (33%) of original height
- Vertebral plana (greater than 90% vertebral body collapse)
- Spinal stenosis with retro pulsed fragments
- Unstable spine requiring surgical stabilization
- Prophylactic vertebroplasty treatment of any vertebrae
- Irreversible life-threatening bleeding disorders
- End stage kidney disease
- Drug dependence (intravenous drug use)
- Pregnancy
- Unable or unwilling to follow the prescribed standard of care follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants with vertebral compression fractures receive vertebroplasty treatment using CONFIDENCE High Viscosity Cement.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for up to 12 months after the vertebroplasty to assess improvement in sagittal balance, back pain, and complications.
Follow-up visits over 12 months (schedule may vary)
Trial Site Locations
Total: 1 location
1
Clinique Bois Cerf
Lausanne, Switzerland
Actively Recruiting
Research Team
N
Nicolas Prof Theumann, Medical Doctor
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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