A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures

NCT01482793 | Completed DMC

• 2 other identifiers: WGT4PVAPOUR
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Compression Fractures; Osteoporotic Vertebral Compression Fractures; Acute Vertebral Fractures

Outcome Measures

Primary Outcomes (1)

• Patient rated pain intensity

  two weeks

Secondary Outcomes (1)

• Functional Disability

  two weeks

Study Arms (2)

AVAMAX

ACTIVE COMPARATOR

Avamax vertebroplasty kits provided by Care Fusion

Procedure: Vertebroplasty

Simulated injection procedure

NO INTERVENTION

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.

Interventions

Vertebroplasty PROCEDURE

AVAmax radiopaque bone cement is injected into the vertebral body using a 13 G or 11 G vertebroplasty needle.

AVAMAX

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Optimus Clinical Research: lead
• C. R. Bard: collaborator

Study Sites (1)

Optimus Clinical Research

Sydney, New South Wales, 2217, Australia

Location

Related Publications (2)

• 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.

  PMID: 27544377 DERIVED

• 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.

  PMID: 25873274 DERIVED

MeSH Terms

Interventions

Vertebroplasty

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• William Clark

  St George Private Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 1, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 13, 2015

Record last verified: 2015-07

Locations

AU (1)