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

February 13, 2025 updated by: Prof Nicolas Theumann

PROTECT - 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vertebroplasty cohort
Patients with vertebral compression fractures treated with vertebroplasty
Device: Vertebroplasty
Vertebral compression fractures treated with CONFIDENCE High Viscosity Cement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of sagittal balance
Time Frame: Up to 12 months post index surgery
measurement of sagittal vertical axis (SVA)
Up to 12 months post index surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Back Pain
Time Frame: Up to 12 months post index surgery
Measured as NRS scale for back pain
Up to 12 months post index surgery
Quebec Score
Time Frame: 6-12 months post index surgery
Measured as the standard Quebec Score
6-12 months post index surgery
Complications
Time Frame: Up to 12 months post-index surgery
Up to 12 months post-index surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof Nicolas Theumann

Collaborators

Johnson & Johnson
Dr Danoob Dalili

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Actual)

November 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THU-2023-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pathological Fracture

Clinical Trials on Vertebroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe