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A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01482793
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : July 13, 2015
Information provided by (Responsible Party):
Paul Bird, Optimus Clinical Research

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 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

Resource links provided by the National Library of Medicine

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.

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01482793

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Australia, New South Wales
Optimus Clinical Research
Sydney, New South Wales, Australia, 2217
Sponsors and Collaborators
Optimus Clinical Research
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Principal Investigator: William Clark St George Private Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Paul Bird, Principal Investigator, Optimus Clinical Research Identifier: NCT01482793    
Other Study ID Numbers: WGT4P
VAPOUR ( Other Identifier: Other )
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: July 13, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Fractures, Bone
Spinal Fractures
Fractures, Compression
Osteoporotic Fractures
Wounds and Injuries
Spinal Injuries
Back Injuries