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

NCT01537770 | Completed DMC

• 1 other identifier: 2010-024050-10
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vertebroplasty; Low energy osteoporotic vertebral fractures; of the thoracic and/or lumbar spine

Outcome Measures

Primary Outcomes (1)

• Pain relief

  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.

  12 Months

Secondary Outcomes (4)

• Quality of life EQ5D

  12 months

• Physical function, disability etc.

  12 months

• Lung capacity

  12 months

• Subsidence of the affected vertebral bodies and local kyphosis

  12

Study Arms (2)

Vertebroplasty

ACTIVE COMPARATOR

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

lidocaine injection

SHAM COMPARATOR

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

Interventions

Percutaneous vertebroplasty PROCEDURE

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.

Vertebroplasty

Lidocaine injection PROCEDURE

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.

lidocaine injection

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead
• Odense University Hospital: collaborator

Study Sites (1)

Middelfart Spinesurgery research department

Middelfart, Region Syddanmark, 5500, Denmark

Location

MeSH Terms

Conditions

Osteoporotic Fractures

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mikkel Ø Andersen, MD, associate Professor

  Sygehus Lillebaelt

  STUDY CHAIR

• Emil J Hansen, MD, PhD student

  Sygehus Lillebaelt

  PRINCIPAL INVESTIGATOR

• Rikke Rousing, PhD

  Sygehus Lillebaelt

  STUDY DIRECTOR

• Hans Tropp, MD, Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: February 23, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2015
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

DK (1)