Laredo (OSTEO‐6).

Methods	Randomised controlled trial, open‐label
Participants	N = 48 (planned sample size 300) Inclusion criteria Patient is able to undergo the vertebroplasty or balloon kyphoplasty procedure Patient must have signed the consent form (ZELEN randomisation protocol) Male or female, 50 years or older One or two non‐traumatic vertebral fracture(s) between T5 and L5 Of osteoporotic origin (low‐speed trauma such as fall from his own height or less than 80 cm) Fracture(s) of less than 6 weeks duration after the onset of pain related to the fracture and fracture(s) exhibit(s) high signal intensity on T2‐weighted images and a benign appearance at MRI The patient will be able to receive the selected protocol treatment within 6 weeks after onset of fracture‐related symptoms and within 15 days after treatment randomisation The benign nature of the vertebral fracture has to be confirmed by the results of the biopsy performed during vertebroplasty or balloon kyphoplasty or by one year follow‐up in the conservative treatment group Exclusion criteria Patient with a vertebral fracture of more than 6‐week duration after onset of fracture‐related symptoms Neurological signs related to the vertebral fracture to treat History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain More than two recent vertebral fractures Current infection Impossibility to perform the percutaneous approach of the vertebra to treat. Reduction by more than 50% of the anteroposterior width of the bony spinal canal due to the vertebral fracture to treat. Known allergy to a contrast media or to one of the cement components used for kyphoplasty Vertebral fracture with loss of 90% or more of the vertebral body height Neurological signs or symptoms related to the vertebral fracture Malignant and traumatic vertebral fractures Contraindication to MRI: Metallic implant (pace‐maker, 'non movible auditive implant, metallic vascular or cardiac device; metallic surgical clips; claustrophobia Evolutive cardiac disease non reactive to medical treatment Patient presenting a non correctable spontaneous or therapeutic coagulation disorder. Presence of an unexplained biological inflammatory syndrome with NFS = 20 Noncompliant patient: Impossibility to participate to the study and to be followed up for 1 year. Pregnant or breast feeding women Patient not affiliated to social security
Interventions	Vertebroplasty Kyphoplasty Usual care with or without brace
Outcomes	Follow‐up to one year Primary outcome Change in Vertebral Kyphotic angle between preoperative and one‐year follow‐up measurements Secondary outcomes Pain evaluation using a VAS Analgesics intake according to the WHO classification (Classes 1, 2 and 3) Changes in anterior, mid and posterior vertebral heights of the treated vertebral body Changes in height of the intervertebral disc spaces adjacent to the treated vertebra Cost evaluation in a sample of 10% of patients randomly selected including the following costs: intervention cost; medical treatment costs; consultation costs; hospitalisation cost; complication costs EIFEL questionnaire for back pain evaluation Follow‐up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements, on 3 cuts TDM on the sagittal level : lateral right, median and lateral left Intensity of signal with T2 sequence Number of new vertebral fractures occurring during the one‐year follow‐up period Quality of life evaluation (QUALEFFO ‐ SF 12). Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle
Study name	Prospective randomized comparative study of balloon kyphoplasty, vertebroplasty and conservative management in acute osteoporotic vertebral fractures of less than 6 weeks
Starting date	December 2007
Contact information	Principal Investigator: Jean‐Denis Laredo
Notes	Trial Registration: NCT0749060 ('OSTEO‐6') Primary sponsor: Assistance Publique ‐ Hôpitaux de Paris; Secondary sponsor: Ministry of Health, France Completed June 2012.