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Vertebroplasty Compared With a Sham-procedure for Painful Acute Osteoporotic Vertebral Fractures

NCT01537770 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-05-06

No results posted yet for this study

Summary

The main purpose of this study:

\- to determine whether vertebroplasty has a pain palliating effect superior to a sham-procedure for acute painful osteoporotic vertebral fractures of the thoracic and lumbar spine.

Secondary purposes:

* To determine if there are differences in the two methods on preventing forward tilting of the spine and/or shortening of the total height of the spine.
* measure if there are differences in change of lung capacity between the two methods

Conditions

  • Osteoporotic Fractures

Interventions

PROCEDURE

Percutaneous vertebroplasty

Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the PMMA reaches to the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein.

PROCEDURE

Lidocaine injection

Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. 2 ml of 1% Lidocaine is injected in each needle. Bone cement is prepared on the bench simulating the vertebroplasty-procedure.

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Spine Centre of Southern Denmark

    lead OTHER

Principal Investigators

  • Mikkel Ø Andersen, MD, associate Professor · Sygehus Lillebaelt

  • Emil J Hansen, MD, PhD student · Sygehus Lillebaelt

  • Rikke Rousing, PhD · Sygehus Lillebaelt

  • Hans Tropp, MD, Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-04-30
Completion
2015-04-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01537770 on ClinicalTrials.gov