Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06670404

Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Vertebral Compression Fractures Facet Joint Arthropathy Fractures, Bone Fractures, Spontaneous Pathological Fracture Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Bois Cerf

Lausanne, Switzerland

Location status: Recruiting

Location contact

Nicolas Prof Theumann, Medical Doctor

CONTACT

[email protected]

0041795251859

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vertebroplasty

Device

Vertebral compression fractures treated with CONFIDENCE High Viscosity Cement

Primary outcomes

  1. Improvement of sagittal balance

    Time frame: Up to 12 months post index surgery

    measurement of sagittal vertical axis (SVA)

Secondary outcomes

  1. Improvement in Back Pain

    Time frame: Up to 12 months post index surgery

    Measured as NRS scale for back pain

  2. Quebec Score

    Time frame: 6-12 months post index surgery

    Measured as the standard Quebec Score

  3. Complications

    Time frame: Up to 12 months post-index surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas Prof Theumann, Medical Doctor

CONTACT

[email protected]

0041795251859

Sponsors and collaborators

Lead sponsor

Prof Nicolas Theumann

Other

Collaborators

  • Dr Danoob Dalili
  • Johnson & Johnson

Registry information

Official study title

PROTECT - Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures

Acronym: PROTECT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.