Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vertebroplasty.
- Who it may be relevant to
- Registry conditions: Vertebral Compression Fractures, Pathological Fracture, Facet Joint Arthropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PROTECT - Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Overview
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
- Device Vertebroplasty
Vertebral compression fractures treated with CONFIDENCE High Viscosity Cement
Primary outcome measures
- Improvement of sagittal balance [Time frame: Up to 12 months post index surgery]
Secondary outcome measures (3)
- Improvement in Back Pain [Time frame: Up to 12 months post index surgery]
- Quebec Score [Time frame: 6-12 months post index surgery]
- Complications [Time frame: Up to 12 months post-index surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Switzerland · 1 center
- Clinique Bois Cerf — Lausanne
Identifiers
NCT: NCT06670404 · THU-2023-010