A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Optimus Clinical Research.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Care Fusion
Information provided by (Responsible Party):
Paul Bird, Optimus Clinical Research
ClinicalTrials.gov Identifier:
NCT01482793
First received: November 28, 2011
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

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 Intervention
Vertebral Compression Fractures
Osteoporotic Vertebral Compression Fractures
Acute Vertebral Fractures
Procedure: Vertebroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures.

Resource links provided by NLM:


Further study details as provided by Optimus Clinical Research:

Primary Outcome Measures:
  • Patient rated pain intensity [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Disability [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    Functional Disability (Roland Morris disability score) will be measured at 3 days, 7 days, 1 month, 3 and 6 months.


Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482793

Locations
Australia, New South Wales
Optimus Clinical Research Recruiting
Sydney, New South Wales, Australia, 2217
Contact: Wendy Gellatley    61 2 9587 0238    wgellatley@optimusresearch.com.au   
Principal Investigator: Paul Bird         
Sponsors and Collaborators
Optimus Clinical Research
Care Fusion
Investigators
Principal Investigator: William Clark St George Private Hospital
  More Information

No publications provided

Responsible Party: Paul Bird, Principal Investigator, Optimus Clinical Research
ClinicalTrials.gov Identifier: NCT01482793     History of Changes
Other Study ID Numbers: WGT4P, VAPOUR
Study First Received: November 28, 2011
Last Updated: November 30, 2011
Health Authority: Australia: Therapeutic Goods Administration

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Compression
Osteoporotic Fractures
Spinal Fractures
Back Injuries
Spinal Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 29, 2014