Clinical trial NCT02370628: Vertebroplasty In The Treatment Of Acute Fracture Trial - The VITTA Trial
Official title: Vertebroplasty In The Treatment Of Acute Fracture Trial (The VITTA Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vertebral Compression Fractures
Keywords: percutaneous vertebroplasty
facet block
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2015-02-25
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Achieving a score of 75 or higher on the Barthel Index functional evaluation score
timeFrame: 30 days after treatment
Secondary outcomes:
measure: Rate of cross-over to the alternative treatment
timeFrame: 15 days after treatment
measure: Level of pain as measured by the visual analogue pain scale
timeFrame: at 15 days and 30 days
measure: Proportion of patients located at home
timeFrame: 15 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: CHUM
name: Jean Raymond, MD
role: PRINCIPAL_INVESTIGATOR
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