An interventional study of Percutaneous vertebroplasty and Facet block in Vertebral Compression Fractures, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-14.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment
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.
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.
50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.
This study's enrollment of 2 is below the median of 73 across 32 interventional studies indexed under Fractures, Compression.
Browse Fractures, Compression studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
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if timing of the fracture is unclear, the following criteria are required for inclusion in the trial
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The procedure involves percutaneous application of bone cement (polymethylmethacrylate) into collapsed vertebrae.
Procedure: Percutaneous vertebroplasty · Procedure: Facet block
injection of anti-inflammatory and analgesic drugs
Procedure: Facet block
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.
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.
Achieving a score of 75 or higher on the Barthel Index functional evaluation score
Time frame: 30 days after treatment
Rate of cross-over to the alternative treatment
Time frame: 15 days after treatment
Level of pain as measured by the visual analogue pain scale
Time frame: at 15 days and 30 days
Proportion of patients located at home
Time frame: 15 days
Ran from Apr 2015 to primary completion in Jun 2018, 37 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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