Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT06141187

Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.

Led by Spine Centre of Southern Denmark · Updated on 2025-01-06

240

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this randomized double-blind clinical trial is to determine the efficacy of percutaneous vertebroplasty (PVP) in relieving severe pain in patients with MRI-verified acute or sub-acute osteoporotic vertebral compression fractures (OVCFs) compared to sham as well as examine the socio-economic implications associated with performing vertebroplasty. The primary outcome is improvement of pain intensity as measured on a Visual Analog Scale (VAS, 0 to100) 12 weeks after treatment. Secondary outcomes include patient-reported back-related disability, patient-reported quality of life, spinal sagittal balance, complications associated with the procedure, incidence of new OVCFs and socioeconomic costs.

CONDITIONS

Official Title

Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 50 years or older with symptomatic osteoporotic spinal compression fractures between T6 and L5
  • Focal tenderness at the level of the vertebral fracture
  • Fractures confirmed by MRI showing vertebral edema
  • Osteoporotic fractures type 1 to 4
  • Fracture involves no more than 4 vertebral levels
  • Vertebroplasty can be performed in one session
  • Back pain score of 60 or higher on Visual Analog Scale (VAS 0-100)
  • Ability to understand and read Danish
  • Written informed consent provided
  • Relevant pain started within 3 months before enrollment
Not Eligible

You will not qualify if you...

  • Contraindications for spine surgery
  • Platelet count below 30 mia/l
  • Osteoporotic fractures type 5 and Pincer-type
  • Complete collapse of vertebral body preventing needle insertion
  • Presence of neurologic deficit
  • Contraindications for MRI scanning
  • Psychological or psychiatric disorders expected to affect compliance
  • Active malignancy
  • Mini Mental State Examination (MMSE) score below 24
  • History of chronic back pain requiring ongoing opiate use
  • Systemic or local spine infection

AI-Screening

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Trial Site Locations

Total: 1 location

1

Rygcenter Syddanmark

Middelfart, Fyn, Denmark, 5500

Actively Recruiting

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Research Team

M

Mikkel Ø Andersen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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