Trial record 8 of 16 for:    Open Studies | "Back Injuries"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Sygehus Lillebaelt
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Emil J Hansen, Sygehus Lillebaelt
ClinicalTrials.gov Identifier:
NCT01537770
First received: February 17, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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

Condition Intervention Phase
Osteoporotic Fractures
Procedure: Percutaneous vertebroplasty
Procedure: Lidocaine injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Study for Comparison of Percutaneous Vertebroplasty Opposite - Infiltration of the Periost and Vertebral Body With Lidocaine - as Pain Palliative Treatment of Osteoporotic Vertebral Fractures of the Thoracic and Lumbar Spine

Resource links provided by NLM:


Further study details as provided by Sygehus Lillebaelt:

Primary Outcome Measures:
  • Pain relief [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Primary outcome will be pain relief at 1 day, 1-12 weeks, and 12 months. The questionnaire consist of the VAS score and questions about use, ammount and type of pain medication. Patients are asked to fill out the VAS and NRS score, and use of analgesics is recorded once every week during the first 3 months after randomization.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Quality of life as meassured with the EuroQol 5D questionnaire at 3 and 12 months. It consists of 5 different questions.

  • Physical function, disability etc. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The patients fill out the SF-36 questionnaire at baseline and at 3 and 12 months. It consists of 36 questions containing 8 domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning,emotional role functioning, social role functioning, mental health.

  • Lung capacity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Lungcapacity as examined with a spirometer at 3 and 12 months. The patients history of lungdiseases and use of medicin affecting the lungcapacity is registered at baseline and at 3 and 12 months.

  • Subsidence of the affected vertebral bodies and local kyphosis [ Time Frame: 12 ] [ Designated as safety issue: No ]
    X-ray images of the entire spine, lateral view at 3 and 12 months.


Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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 cement 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: 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.
Sham Comparator: 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.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • VCF on X-ray of the spine (minimal 15% loss of height) level of VCF Th6 or lower
  • back pain ≤ 8 weeks at time of surgery
  • ≥ 50 years of age
  • bone edema on MRI of the fractured vertebral body
  • focal tenderness on VCF level

Exclusion Criteria:

  • severe cardio-pulmonary condition
  • untreatable coagulopathy
  • systemic or local infection of the spine (osteomyelitis, spondylodiscitis)
  • suspected alternative underlying disease (malignancy)
  • radicular and/or cauda compression syndrome
  • contra-indication for MRI
  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: NCT01537770

Contacts
Contact: Emil J Hansen, MD, PhD student +45 22136720 emil.jesper.hansen@slb.regionsyddanmark.dk
Contact: Mikkel Ø Andersen, MD +45 40344069 mikkel@dadlnet.dk

Locations
Denmark
Middelfart Spinesurgery research department Recruiting
Middelfart, Region of Southern Denmark, Denmark, 5500
Contact: Karen H Hansen, Research official    +45 63484198    karen.hoejmark.hansen@slb.regionsyddanmark.dk   
Contact: Emil J Hansen, MD, PhD student    +45 22136720    emil.jesper.hansen@slb.regionsyddanmark.dk   
Principal Investigator: Emil J Hansen, MD, PhD student         
Sponsors and Collaborators
Sygehus Lillebaelt
Odense University Hospital
Investigators
Study Chair: Mikkel Ø Andersen, MD, associate Professor Sygehus Lillebaelt
Principal Investigator: Emil J Hansen, MD, PhD student Sygehus Lillebaelt
Study Director: Rikke Rousing, PhD Sygehus Lillebaelt
Study Chair: Hans Tropp, MD, Professor
  More Information

No publications provided

Responsible Party: Emil J Hansen, MD, PhD student, Sygehus Lillebaelt
ClinicalTrials.gov Identifier: NCT01537770     History of Changes
Other Study ID Numbers: 2010-024050-10
Study First Received: February 17, 2012
Last Updated: January 14, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Sygehus Lillebaelt:
Vertebroplasty
Low energy osteoporotic vertebral fractures
of the thoracic and/or lumbar spine

Additional relevant MeSH terms:
Back Injuries
Fractures, Bone
Spinal Fractures
Osteoporotic Fractures
Wounds and Injuries
Spinal Injuries
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014