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

NCT02370628 | Terminated DMC

• 1 other identifier: CE14.334
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Compression Fractures

Keywords

percutaneous vertebroplasty; facet block

Outcome Measures

Primary Outcomes (1)

• Achieving a score of 75 or higher on the Barthel Index functional evaluation score

  30 days after treatment

Secondary Outcomes (3)

• Rate of cross-over to the alternative treatment

  15 days after treatment

• Level of pain as measured by the visual analogue pain scale

  at 15 days and 30 days

• Proportion of patients located at home

  15 days

Study Arms (2)

Percutaneous vertebroplasty (PV)

EXPERIMENTAL

The procedure involves percutaneous application of bone cement (polymethylmethacrylate) into collapsed vertebrae.

Procedure: Percutaneous vertebroplasty; Procedure: Facet block

Facet block

ACTIVE COMPARATOR

injection of anti-inflammatory and analgesic drugs

Procedure: Facet block

Interventions

Percutaneous vertebroplasty PROCEDURE

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.

Percutaneous vertebroplasty (PV)

Facet block PROCEDURE

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.

Facet block; Percutaneous vertebroplasty (PV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• an MRI scan showing edema at the fracture level(s) or
• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (27)

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  BACKGROUND

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  BACKGROUND

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Study Officials

• Jean Raymond, MD

  CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 25, 2015
• Study Start: April 17, 2015
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

CA (1)