A Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures - Full Text View

Purpose

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.

Condition	Intervention	Phase
Osteoporosis Vertebral Fracture	Procedure: percutaneous vertebroplasty Procedure: sham procedure	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Randomised Sham Controlled Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures Osteoporosis

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by St. Elisabeth Hospital, Tilburg, Netherlands:

Primary Outcome Measures:

pain relief [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

back pain related disability [ Time Frame: 0, 1day, 1 week, 1,3,6,12 months ] [ Designated as safety issue: No ]
Back pain related disability as measured with the Roland Morris Disability (RMD) Questionnaire. The Qualeffo is developed specifically for patients with osteoporosis. This questionnaire consists of 41 questions about: pain, physical function, social function, general health perception, and mental function. The RMD questionnaire is a disability questionnaire that measures the functional status of patients with back pain.
Quality of Life [ Time Frame: 1 week, 1,3,6,12 months ] [ Designated as safety issue: No ]
QOL as measured with the Questionnaire of the European Foundation for Osteoporosis (Qualeffo). The Qualeffo is developed specifically for patients with osteoporosis. This questionnaire consists of 41 questions about: pain, physical function, social function, general health perception, and mental function. The Qualeffo score ranges from 0 (best quality of life) to 100 (worst quality of life). This questionnaire will be completed at five measurement moments (before and at 1, 3, 6, and 12 months after the procedure).

Estimated Enrollment:	80
Study Start Date:	January 2011
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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). 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 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.
Sham Comparator: sham 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 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 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.

Arms

Assigned Interventions

Experimental: 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). 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

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.

Sham Comparator: sham 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 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

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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	50 Years to 95 Years
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 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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200277

Contacts

Contact: Willem Jan van Rooij, PhD	+313135391313	wjjvanrooij@gmail.com
Contact: Paul N Lohle, PhD	+313135391313	paullohle@hetnet.nl

Locations

Netherlands
Albert Schweitzer Ziekenhuis	Not yet recruiting
Dordrecht, Netherlands, 3300AK
Contact: Dirk R Halkema, PhD +3178 6541111 d.r.halkema@asz.nl
Contact: Otto E Elgersma, PhD +3178 6541111 ottoelgersma@hotmail.com
Sub-Investigator: F Meenhorst
Catharina Ziekenhuis	Not yet recruiting
Eindhoven, Netherlands, 5623EJ
Contact: Frits Jansen, PhD +31402399111 frits.jansen@catharina-ziekenhuis.nl
Contact: Marion Blonk, PhD +31402399111 marion.blonk@catharina-ziekenhuis.nl
Sub-Investigator: monique vos
Medisch Spectrum Twente	Not yet recruiting
Enschede, Netherlands, 7500KA
Contact: Caroline A Klazen, PhD 05348720 00 cahklazen@hotmail.com
Contact: H Franke, PhD 05348720 00 H.Franke@mst.nl
Principal Investigator: Caroline Klazen, PhD
St. Elisabeth Ziekenhuis	Recruiting
Tilburg, Netherlands, 5022GC
Contact: Willem Jan van Rooij, PhD +313135391313 wjjvanrooij@gmail.com
Principal Investigator: Paul N Lohle, PhD
Sub-Investigator: Jolanda De Vries, PhD
Sub-Investigator: Willem Jan van Rooij, PhD
Sub-Investigator: Job R Juttmann, PhD

Sponsors and Collaborators

St. Elisabeth Hospital, Tilburg, Netherlands

Investigators

Study Director:	Willem Jan van Rooij, PhD	St. Elisabeth Ziekenhuis
Principal Investigator:	Paul N Lohle, PhD	St Elisabeth Ziekenhuis
Study Director:	Jolanda De Vries, PhD	St Elisabeth Ziekenhuis

More Information

No publications provided by St. Elisabeth Hospital, Tilburg, Netherlands

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	WJ van Rooij, St. Elisabeth Ziekenhuis
ClinicalTrials.gov Identifier:	NCT01200277 History of Changes
Other Study ID Numbers:	EZTilburg1
Study First Received:	September 7, 2010
Last Updated:	August 1, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by St. Elisabeth Hospital, Tilburg, Netherlands:

osteoporosis
vertebral fracture
vertebroplasty
percutaneous

Additional relevant MeSH terms:

Fractures, Bone
Osteoporosis
Spinal Fractures
Wounds and Injuries
Bone Diseases, Metabolic

Bone Diseases
Musculoskeletal Diseases
Spinal Injuries
Back Injuries

ClinicalTrials.gov processed this record on May 21, 2013

A Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures (VertosIV)