Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures (PROTECT)

Prof Nicolas Theumann

Status: Enrolling

Conditions: Pathological Fracture; Vertebral Compression Fractures; Facet Joint Arthropathy

Treatments: Device: Vertebroplasty

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06670404

THU-2023-010

Details and patient eligibility

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

130 participants in 1 patient group

Vertebroplasty cohort

Description:

Patients with vertebral compression fractures treated with vertebroplasty

Treatment:

Device: Vertebroplasty