A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (Vertos V)

NCT01963039 | Completed DMC

• 1 other identifier: EZTilburg2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Background The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a relatively new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs in patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses on acute VCFs defined as ≤ 6 weeks. VERTOS III focused on conservative treatment and found that half of patients still had disabling pain after 3 months or longer. These patients with sustained pain after 3 months may benefit from PV. Objective To compare pain relief after PV with a sham intervention in selected patients with a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria as in VERTOS II an IV. Secondary outcome measures are back pain related disability and quality of life. Methods The VERTOS V study is a prospective RCT with pain relief as primary endpoint. Inclusion criteria are a VCF of thoracic level 5 or lower with focal tenderness at fracture level, assessed by an internist on physical examination and a Visual Analogue Scale (VAS) score ≥ 5 for three months or longer, decreased bone density defined as T score ≤ -1 and age 50 years or older. 94 patients will be included, 47 in each arm. Crossovers are not allowed. Follow-up is at regular intervals during one year period with VAS score for pain as primary endpoint. Secondary endpoints are back pain related disability and quality of life measured with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and physical function measured with the Roland Morris Disability questionnaire. Conclusion Vertos V is a methodologically sound masked randomised sham controlled trial of vertebroplasty in patients with sustained pain 3 months or longer after a vertebral compression fracture.

Conditions

Osteoporosis; Vertebral Fracture

Outcome Measures

Primary Outcomes (1)

• Pain relief

  Primary outcome will be pain score at 1 day, 1 week, and 1,3, 6 and 12 months after PV compared to baseline pain score. 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)

percutaneous 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). For the vertebroplasty procedure, 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement (PMMA) 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.

Device: 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(PMMA) 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 DEVICE

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 the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein.

Also known as: § 888.302713 Polymethylmethacrylate (PMMA) Bone Cement.

percutaneous 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 (PMMA) 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 ≥ 12 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
• Stryker Medical: collaborator
• Medtronic: collaborator

Study Sites (1)

Elisabeth Tweesteden Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

Related Publications (1)

• Carli D, Venmans A, Lodder P, Donga E, van Oudheusden T, Boukrab I, Schoemaker K, Smeets A, Schonenberg C, Hirsch J, de Vries J, Lohle P. Vertebroplasty versus Active Control Intervention for Chronic Osteoporotic Vertebral Compression Fractures: The VERTOS V Randomized Controlled Trial. Radiology. 2023 Jul;308(1):e222535. doi: 10.1148/radiol.222535.

  PMID: 37462495 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

• Dennis Carli, drs

  Elisabeth Tweesteden Ziekenhuis/ SJG Weert

  PRINCIPAL INVESTIGATOR

• Paul Lohle, dr.

  Elisabeth-TweeSteden Ziekenhuis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: October 16, 2013
• Study Start: May 1, 2013
• Primary Completion: September 3, 2020
• Study Completion: September 3, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)