CompletedNot Applicable

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

Denmark52 participantsStarted 2012-02

Plain-language 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

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 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

What they're measuring

Pain relief

Timeframe: 12 Months

Trial details

NCT IDNCT01537770

SponsorSpine Centre of Southern Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04

View on ClinicalTrials.gov More Osteoporotic Fractures trials