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. 2018 Nov 6;2018(11):CD006349. doi: 10.1002/14651858.CD006349.pub4

Laredo (STIC2).

Methods Randomised controlled trial, open‐label
Participants N = 97 (planned sample size 200)
Inclusion criteria
  • Patient is able to undergo the vertebroplasty or balloon kyphoplasty procedure

  • Patient has read and signed informed consent

  • 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) older 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

  • Persistent pain despite medical treatment according to VAS = 5 or a last resort to morphine treatment

  • The patient will be able to receive the selected protocol treatment 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.


Exclusion criteria
  • Patient with a vertebral fracture of less than 6 weeks 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

  • Patient with more than 2 fractures corresponding to the inclusion criteria (old fractures are not taken into account)

  • 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 AMOVIBLE 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

Outcomes Follow‐up to one year
Primary outcome
  • Modification of the kyphotic angle of every treated vertebra (between the preoperative angle and measured after 1‐year follow‐up)


Secondary outcomes
  • Analgesics intake according to the WHO classification (Classes 1, 2 and 3)

  • Evaluation of kyphotic angle and global thoracic and lumbar angulations

  • Evaluation of pain through the VAS

  • Evaluation of quality of life (QUALEFFO ‐ SF 12)

  • Follow‐up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements, on 3 cuts CT‐scan on the sagittal level : lateral right, median and lateral left

  • Functional scale (EIFEL) for lumbar pain

  • Intensity of signal with T2 sequence

  • Measurement of anterior, median and posterior height of the discs adjacent to the fracture

  • Measurement of disc angles adjacent to the fracture

  • Medico‐economic follow‐up on 10% of the randomly selected patients: cost of intervention; cost of prescribed medicines; cost of follow‐up visits; cost of subsequent hospitalisation; cost of complications.

  • Number of new vertebral fractures documented radiologically

Study name Prospective randomized study of balloon kyphoplasty and vertebroplasty in subacute (older than 6 weeks) osteoporotic vertebral fractures (STIC2)
Starting date December 2007
Contact information Principal Investigator: Jean‐Denis Laredo
Notes Trial Registration: NCT0749086 ('STIC2')
Primary sponsor: Assistance Publique ‐ Hôpitaux de Paris, France; Secondary sponsor: Ministry of Health, France
Completed June 2012