A Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures

NCT01200277 | Completed Phase 3

• 1 other identifier: EZTilburg1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), is a new minimally invasive technique for pain treatment in which bone cement is injected in the fractured vertebra. Recent RCTs provide conflicting results: two sham-controlled studies show no benefit of PV while an unmasked but controlled RCT found significantly better pain relief after PV at acceptable costs.

Conditions

Osteoporosis; Vertebral Fracture

Keywords

osteoporosis; vertebral fracture; vertebroplasty; percutaneous

Outcome Measures

Primary Outcomes (1)

• pain relief

  Primary outcome will be pain relief at 1 day, 1 week, and 1,3, 6 and 12 months. The questionnaire consist of the VAS score and questions about use of pain medication, pain location, and pain type. Other medical treatment and visits to alternative medical specialists, GP's and physical therapists are recorded and compared between groups. Patients are asked to fill out the VAS score and use of analgesics is recorded on a daily basis during the first month after randomization.

  12 months

Secondary Outcomes (2)

• back pain related disability

  0, 1day, 1 week, 1,3,6,12 months

• Quality of Life

  1 week, 1,3,6,12 months

Study Arms (2)

vertebroplasty

EXPERIMENTAL

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). For the vertebroplasty procedure, 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

sham procedure

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). During the sham intervention, verbal and physical cues, such as pressure on the patient's back, are given, and the bone cement is prepared to simulate the odor associated with mixing of polymethacrylate , but the needle is not placed and cement is not injected.

Procedure: sham procedure

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. For the vertebroplasty procedure, 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

sham procedure 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. During the sham intervention, verbal and physical cues, such as pressure on the patient's back, are given, and the methacrylate monomer is opened to simulate the odor associated with mixing of cement, but the needle is not placed and cement is not injected.

sham procedure

Eligibility Criteria

• Age: 50 Years - 95 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 Th5 or lower
• back pain ≤ 6 weeks at time of X-ray
• ≥ 50 years of age
• bone edema on MRI of the fractured vertebral body
• focal tenderness on VCF level
• decreased bone density T-scores ≤ -1

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

• Elisabeth-TweeSteden Ziekenhuis: lead

Study Sites (4)

Albert Schweitzer Ziekenhuis

Dordrecht, 3300AK, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623EJ, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500KA, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, 5022GC, Netherlands

Location

Related Publications (3)

• Firanescu CE, de Vries J, Lodder P, Schoemaker MC, Smeets AJ, Donga E, Juttmann JR, Klazen CAH, Elgersma OEH, Jansen FH, van der Horst I, Blonk M, Venmans A, Lohle PNM. Percutaneous Vertebroplasty is no Risk Factor for New Vertebral Fractures and Protects Against Further Height Loss (VERTOS IV). Cardiovasc Intervent Radiol. 2019 Jul;42(7):991-1000. doi: 10.1007/s00270-019-02205-w. Epub 2019 Apr 2.

  PMID: 30941490 DERIVED

• Firanescu CE, de Vries J, Lodder P, Venmans A, Schoemaker MC, Smeets AJ, Donga E, Juttmann JR, Klazen CAH, Elgersma OEH, Jansen FH, Tielbeek AV, Boukrab I, Schonenberg K, van Rooij WJJ, Hirsch JA, Lohle PNM. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ. 2018 May 9;361:k1551. doi: 10.1136/bmj.k1551.

  PMID: 29743284 DERIVED

• Firanescu C, Lohle PN, de Vries J, Klazen CA, Juttmann JR, Clark W, van Rooij WJ; VERTOS IV study group. A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV). Trials. 2011 Apr 5;12:93. doi: 10.1186/1745-6215-12-93.

  PMID: 21466679 DERIVED

MeSH Terms

Conditions

Osteoporosis; Spinal Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Willem Jan van Rooij, PhD

  St. Elisabeth Ziekenhuis

  STUDY DIRECTOR

• Paul N Lohle, PhD

  St Elisabeth Ziekenhuis

  PRINCIPAL INVESTIGATOR

• Jolanda De Vries, PhD

  St Elisabeth Ziekenhuis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: WJ van Rooij, St. Elisabeth Ziekenhuis.

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 13, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

NL (4)