Clinical trial NCT06670404: Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Official title: PROTECT - Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vertebral Compression Fractures
Pathological Fracture
Facet Joint Arthropathy
Keywords: vertebroplasty
CONFIDENCE High Viscosity Spinal Cement
observational post-market study
Lead sponsor: Hirslanden Clinique Bois-Cerf Lausanne
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
name: Dr Danoob Dalili
First posted: 2024-11-01
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients with vertebral compression fractures from osteoporosis or tumor eligible to be treated with vertebroplasty.

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

Primary outcomes:
measure: Improvement of sagittal balance
timeFrame: Up to 12 months post index surgery
Secondary outcomes:
measure: Improvement in Back Pain
timeFrame: Up to 12 months post index surgery
measure: Quebec Score
timeFrame: 6-12 months post index surgery
measure: Complications
timeFrame: Up to 12 months post-index surgery
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Clinique Bois Cerf
Study officials:
References: