A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures

Study Description

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Brief Summary:

The objective of this study is to gather data regarding the efficacy, safety and cost-effectiveness of percutaneous vertebroplasty in the acute fracture group with fractures less than 6 weeks old. The AVAMAX vertebroplasty kits (Care Fusion) will be used for all vertebroplasties.

The primary effectiveness analysis will be based on the number of patients whose numeric rating pain score drops from above 7 out of 10 at baseline to below 4 out of 10 at two weeks post-intervention. Our hypothesis is that the vertebroplasty group will have a significantly larger proportion of patients achieving pain reduction than the control group. A secondary analysis will compare the change in mean pain scores and specific activity related pain scores between the two groups at 3 days, 14 days and at 1, 3 and 6 months. Another secondary effectiveness analysis will include the mean change in the back-pain specific limitation in function as quantified by the Roland Scale at these same data collection time points.

Condition or disease	Intervention/treatment	Phase
Vertebral Compression Fractures; Osteoporotic Vertebral Compression Fractures; Acute Vertebral Fractures	Procedure: Vertebroplasty	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures.
Study Start Date :	November 2011
Actual Primary Completion Date :	May 2015
Actual Study Completion Date :	May 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: AVAMAX; Avamax vertebroplasty kits provided by Care Fusion	Procedure: Vertebroplasty; AVAmax radiopaque bone cement is injected into the vertebral body using a 13 G or 11 G vertebroplasty needle.
No Intervention: Simulated injection procedure; Patient will be unaware as to whether the control procedure or vertebroplasty had been performed since full sterile preparation, sedation and simulated injection procedure will be used.

Outcome Measures

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Primary Outcome Measures :

1. Patient rated pain intensity [ Time Frame: two weeks ]

Secondary Outcome Measures :

1. Functional Disability [ Time Frame: two weeks ]
   Functional Disability (Roland Morris disability score) will be measured at 3 days, 7 days, 1 month, 3 and 6 months.

Eligibility Criteria

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Ages Eligible for Study:	60 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria/Exclusion Criteria:

• Patient is greater than 60 years of age.
• Patient has pain which is not adequately controlled by oral analgesia or which has required hospitalisation and prevents early mobilisation
• Patient has pain from one or two compression fractures of the vertebrae in the areas T4 to L5 confirmed with a sagittal STIR (short tau inversion recovery) and sagittal T1 weighted MRI scan of the spine. Patients with three or more recent fractures are excluded.
• Clinical history verifies that patient's fracture occurred in the previous 6 weeks.
• Patient does not have a known coagulopathy. If on warfarin, the INR should be less than 2.5 within the last three days.
• Patient has no contraindications for conscious sedation.
• Patient reports pain during ambulation or movement from the compression fracture(s) of at least seven (7) out of ten (10) on a numerical pain scale.
• Patient has access to a telephone.
• Patient speaks English well enough to answer all health questions via telephone.
• Patient has a confirmed diagnosis of osteoporosis via a BMD within 6 months of baseline or a QCT at baseline.
• Patient does not have a history of debilitating chronic back pain which requires regular analgesia.
• Patients with chronic back pain who regularly use medication containing any narcotic for a period greater than 6 weeks, that is prior to the acute fracture.
• Patient does not have significant retropulsed fragment or spinal canal compromise of greater than 20% by retropulsed fragment.
• Patient has no mental incapacity or dementia that makes him/her unable to give informed consent.
• Patient has no history of vertebral osteomyelitis.
• Patient has vertebral body collapse not greater than 60% relative to closest intact vertebra.
• Patient has no pedicle fractures.
• Patient has no active local or systemic infection.
• Patient has not had surgery (within the last 60 days).
• Patient has no concomitant hip fracture.
• Patient has no malignant tumour deposit (multiple myeloma), tumour mass, or tumour extension into the epidural space at the level of the fracture to be treated on MRI.
• Patient does not have severely immunocompromised health status (including any patient who is HIV positive, currently on chemotherapy, taking high doses of long term corticosteroids - defined as a dose of prednisone exceeding 10mg for greater than 3 months in the last 12 months, has a hematologic malignancy, or a transplant recipient.)
• Patient able to attend face to face visits.

Contacts and Locations

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Locations

Australia, New South Wales
Optimus Clinical Research
Sydney, New South Wales, Australia, 2217

Sponsors and Collaborators

Optimus Clinical Research

CareFusion

Investigators

Principal Investigator:	William Clark	St George Private Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Clark W, Bird P, Gonski P, Diamond TH, Smerdely P, McNeil HP, Schlaphoff G, Bryant C, Barnes E, Gebski V. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 1;388(10052):1408-1416. doi: 10.1016/S0140-6736(16)31341-1. Epub 2016 Aug 17. Erratum in: Lancet. 2017 Feb 11;389(10069):602.

Clark W, Bird P, Diamond T, Gonski P. Vertebroplasty for acute painful osteoporotic fractures (VAPOUR): study protocol for a randomized controlled trial. Trials. 2015 Apr 12;16:159. doi: 10.1186/s13063-015-0671-8.

Responsible Party:	Paul Bird, Principal Investigator, Optimus Clinical Research
ClinicalTrials.gov Identifier:	NCT01482793 History of Changes
Other Study ID Numbers:	WGT4P; VAPOUR ( Other Identifier: Other )
First Posted:	December 1, 2011
Last Update Posted:	July 13, 2015
Last Verified:	July 2015

Additional relevant MeSH terms:

Fractures, Bone; Spinal Fractures; Fractures, Compression; Osteoporotic Fractures	Wounds and Injuries; Spinal Injuries; Back Injuries