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

June 13, 2018 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Vertebroplasty In The Treatment Of Acute Fracture Trial (The VITTA Trial)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of acute vertebral fractures.

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

Vertebral compression fractures (VCFs) frequently result in debilitating pain, impaired functional status and bad quality of life. Percutaneous vertebroplasty (PV) is a treatment for VCFs originally developed in France in the late 1980s and first performed in America in the mid-1990s. The procedure involves percutaneous application of bone cement (polymethylmethacrylate) into collapsed vertebrae.

VCFs are a significant public health problem with approximately 750,000 new fractures occurring in the United States each year, a number that is projected to rise as the population ages. In fact, one quarter of adults over the age of 50 will suffer at least one VCF in their lifetime. VCFs cause short term and occasionally long-term pain and disability, and although not immediately life threatening, they are associated with long term mortality. Before the advent of PV, the treatment for VCFs was limited to medical therapy- addressing the pain associated with the fracture but not the fracture itself thus making VCFs practically the only skeletal fracture not treated with orthopedic surgery. Since the introduction of vertebroplasty, over 800 papers, technical notes, and reviews that address this technique have been published with the overwhelming majority reporting significant pain relief and advocating the adoption of the procedure into common practice. Unfortunately, most of these studies had low evidence level and poor scientific design until randomized clinical trials were published in 2009.

Vertebroplasty for refractory back pain (after a period of conservative management of 1 month) constituted the main indication in the overwhelming majority of studies published so far. Although those studies have largely suggested that it does not offer significant improvement in pain or functional status relative to medical therapy or infusion of local anesthesia after this acute phase, the data remains inconclusive and of poor scientific quality. The present study proposes a different rationale: the benefits of vertebroplasty may be occurring in the acute phase (before 1 month) by providing immediate pain relief to the patient, hence allowing early mobilization and preventing medical complications associated with bed rest. In other terms, vertebroplasty may be a first line, acute phase treatment. If the investigators hypothesis holds true, an adequately powered clinical trial may provide sufficient evidence to change the medical indications for vertebroplasty.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de l'Universite de Montreal (CHUM)

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years
  • Presence of:
  • at least one and at most two acute VCF (< 6 weeks) at levels caudate to T4, confirmed with physical examination and radiographic imaging

  • if timing of the fracture is unclear, the following criteria are required for inclusion in the trial

    1. an MRI scan showing edema at the fracture level(s) or
    2. a bone scan showing increased uptake
  • Physical examination showing axial back pain likely secondary to the VCF with restricted mobilization (score not maximum on any one of the following Barthel's Index items: transfer, mobility, bathing, dressing, stairs and toilet use)
  • French or English speaking patient willing to return for follow-up or capable of following up with phone interviews if needed

Exclusion Criteria:

  • Recent (<30 days) major surgery causing debilitating pain
  • Coagulopathy or thrombocytopenia precluding interventional treatment
  • Inability to provide informed consent

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Percutaneous vertebroplasty (PV)
The procedure involves percutaneous application of bone cement (polymethylmethacrylate) into collapsed vertebrae.
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.
ACTIVE_COMPARATOR: Facet block
injection of anti-inflammatory and analgesic drugs
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Achieving a score of 75 or higher on the Barthel Index functional evaluation score
Time Frame: 30 days after treatment
30 days after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of cross-over to the alternative treatment
Time Frame: 15 days after treatment
15 days after treatment
Level of pain as measured by the visual analogue pain scale
Time Frame: at 15 days and 30 days
at 15 days and 30 days
Proportion of patients located at home
Time Frame: 15 days
15 days

Collaborators and Investigators

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

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Jean Raymond, MD, CHUM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 17, 2015

Primary Completion (ACTUAL)

June 5, 2018

Study Completion (ACTUAL)

June 5, 2018

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (ESTIMATE)

February 25, 2015

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE14.334

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.

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