Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures

NCT06670404 | Recruiting FDA Device

• 1 other identifier: THU-2023-010
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Compression Fractures; Pathological Fracture; Facet Joint Arthropathy

Keywords

vertebroplasty; CONFIDENCE High Viscosity Spinal Cement; observational post-market study

Outcome Measures

Primary Outcomes (1)

• Improvement of sagittal balance

  measurement of sagittal vertical axis (SVA)

  Up to 12 months post index surgery

Secondary Outcomes (3)

• Improvement in Back Pain

  Up to 12 months post index surgery

• Quebec Score

  6-12 months post index surgery

• Complications

  Up to 12 months post-index surgery

Study Arms (1)

Vertebroplasty cohort

Patients with vertebral compression fractures treated with vertebroplasty

Device: Vertebroplasty

Interventions

Vertebroplasty DEVICE

Vertebral compression fractures treated with CONFIDENCE High Viscosity Cement

Vertebroplasty cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• Unable or unwilling to follow the standard of care prescribed follow-up visits

Sponsors & Collaborators

• Prof Nicolas Theumann: lead
• Johnson & Johnson: collaborator
• Dr Danoob Dalili: collaborator

Study Sites (1)

Clinique Bois Cerf

Lausanne, Switzerland

RECRUITING

MeSH Terms

Conditions

Fractures, Spontaneous

Interventions

Vertebroplasty

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Nicolas Prof Theumann, Medical Doctor

CONTACT

0041795251859; nicolas.theumann@hirslanden.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

CH (1)