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Vertebroplasty In The Treatment Of Acute Fracture Trial - The VITTA Trial

NCT02370628 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-06-14

No results posted yet for this study

Summary

The VITTA trial is a randomized, controlled, single-blinded, cross-over trial comparing percutaneous vertebroplasty with facet block in patients with acute (\<1month) and painful vertebral compression fractures.

The treatment offered for vertebral compression fractures (VCFs) in the interventional arm of the trial is vertebroplasty, which will be performed in accordance with the standardized protocol of the Canadian Association of Radiologists. Patients in the control arm will receive facet block, where a long-acting local anesthetic agent and corticosteroids are injected in the spinal articular facets at the affected level.

Conditions

  • Vertebral Compression Fractures

Interventions

PROCEDURE

Percutaneous vertebroplasty

The procedure involves percutaneous application of bone cement (polymethylmethacrylate) into collapsed vertebrae, and has been used for treatment of patients with osteoporosis who have severe or prolonged pain following vertebral compression fracture, as well as those with painful, aggressive hemangiomas and osteolytic neoplasms. In our trial, vertebroplasty shall be performed in two steps: * Step 1: facet block * Step 2: cement infusion Therefore, patients in both arms will undergo Step 1 since our control intervention serves as a routine first part of our active intervention.

PROCEDURE

Facet block

A long-acting local anesthetic agent and corticosteroids are injected in the spinal articular facets at the affected level. All patients will undergo facet block since it serves as a routine first part to percutaneous vertebroplasty.

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Jean Raymond, MD · CHUM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-17
Primary Completion
2018-06-05
Completion
2018-06-05

Countries

  • Canada

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 NCT02370628 on ClinicalTrials.gov