Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures

Not Applicable

Completed

Conditions: of Less Than 6 Weeks Duration
Between T5 and L5
Osteoporotic Vertebral Fracture

Interventions: Other: conventional treatment
Procedure: kyphoplasty with balloons
Procedure: vertebroplasty

Brief Summary: This study aims to compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.

Detailed Description: The three treatments are the following: 1/Conventional medical treatment including rest and pain medications2/Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement) through a posterior route through the vertebral pedicles under radiological guidance.3/Balloon Kyphoplasty which consists of placing through a percutaneous posterior approach under radiological guidance, into the fractured vertebra a balloon which is inflated with fluid and creates a cavity. This may restore part of the vertebral height loss due to the fracture. In addition, after balloon deflation, polymethylmetacrylate cement may be injected with low pressure into the created cavity. The study will indicate if balloon kyphoplasty is able to restore vertebral height of the fractured vertebra better than medical treatment and vertebroplasty.

Recruitment & Eligibility

Inclusion Criteria

Patient is able to undergo the vertebroplasty or Balloon kyphoplasty procedure
Patient must have signed the consent form (ZELEN Randomization protocol)
Male or female, 50 years or older
One or two non-traumatic vertebral fracture(s):
- 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 The 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 randomization.
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 movable auditive implant, metallic vascular or cardiac device
- Metallic surgical clips
- Claustrophobia
Evolutive cardiac disease nonreactive to medical treatment
Patient presenting a non correctable spontaneous or therapeutic coagulation disorder.
Presence of an unexplained biological inflammatory syndrome with NFS≥20
Non compliant 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

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change in Vertebral Kyphotic angle between preoperative and one-year follow-up measurements.	1 year

Secondary Outcome Measures

Name	Time	Method
Analgesics intake according to the WHO classification (Classes 1, 2 and 3).	J-20 à J-7 / J6 / J45 /J90 /J180 / J360
1° - Pain evaluation using a visual analogic scale	J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Quality of life evaluation (QUALEFFO - Short-Form SF12).	J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle	J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Changes in anterior, mid and posterior vertebral heights of the treated vertebral body	J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Changes in height of the intervertebral disc spaces adjacent to the treated vertebra	J-20 à J-7 / J6 / J45 /J90 /J180 / J360
questionnaire (Eifel) for back pain evaluation	J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Number of new vertebral fractures occurring during the one year follow-up period	J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements, on 3 cuts tomodensitometry (tdm) on the sagittal level : lateral right, median and lateral left	preoperative, at J6 and at J360
Cost evaluation in a sample of 10% of patients randomly selected including the following costs : o Intervention cost. o Medical treatment costs o Consultation costs. o Hospitalization cost o Complication costs	J-20 à J-7 / J6 / J45 /J90 /J180 / J360
Intensity of signal with T2 sequence	preoperative and at J360

Locations (1): Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire
🇫🇷
Paris, France