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Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures

NCT03617094 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-01-06

No results posted yet for this study

Summary

The aim of this study is to evaluate the efficacy of carrying out early vertebroplasty procedure, compared to the standard conservative treatment (corset), in order to prevent residual deformations that could occur in complications of vertebral fractures that are medically treated using a corset.

This is a monocentric, randomized, parallel group, prospective and open-label study.

Conditions

  • Vertebral Fracture

Interventions

DEVICE

Early percutaneous vertebroplasty (EPV)

Treatment consists of percutaneous acrylic bone cement injection using a trocar under scope control and general anesthesia.

DEVICE

Standard Conservative treatment (CT)

Treatment consists of using a made-to-measure 3 point thoracolumbar corset,that is worn for 3 months: night and day during the first 6 week period of the treatment, and then only the day for the next 6 week period.

Sponsors & Collaborators

  • Clinical Investigation Centre for Innovative Technology Network

    collaborator NETWORK

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Mehdi Boudissa, MD · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-05
Primary Completion
2020-10-17
Completion
2020-10-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03617094 on ClinicalTrials.gov