VERTOS V.

Trial name or title	VERTOS V
Methods	Randomised controlled trial, participant blinded
Participants	Planned sample size = 94 Inclusion criteria 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 Age 50 to 90 years Bone oedema 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, spondylodisciitis) Suspected alternative underlying disease (malignancy) Radicular and/or cauda compression syndrome Contra‐indication for MRI
Interventions	Vertebroplasty Sham procedure (verbal and physical cues (e.g. pressure on the back) and the methacrylate monomer is opened to simulate the odour of mixing the bone cement, but the needle is not placed and the no cement is injected)
Outcomes	Duration of follow‐up to 12 months Primary outcome Pain score using VAS and questions relating to use of pain medication, pain location and type of pain (recorded daily for first month after randomisation) Other medical treatment and visits to alternative medical specialists, GP's and physical therapists are recorded Secondary outcomes Disability related to back pain with RMDQ questionnaire Quality of life measured with QoLQ of European foundation for osteoporosis Physical function measured with RMDQ questionnaire
Starting date	May 2013
Contact information	Dr Dennis Carli
Notes	Trial registration: NCT01963039 Primary sponsor: St. Elisabeth Hospital, Tilburg, the Netherlands Study completed June 2015 (as reported at clinicaltrials.gov in September 2016); no study results posted. Status changed 12 January 2017: study now 'enrolling by invitation', with a new estimated completion date of July 2018

MRI: magnetic resonance imaging
 ODI: Oswestry disability index
 OVCF: osteoporotic vertebral compression fracture
 RMDQ: Roland‐Morris Disability Questionnaire
 QUALEFFO: Quality of Life Questionnaire of the European Foundation for Osteoporosis
 VAS: visual analogue scale
 VCF: vertebral compression fracture