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

Osteoporotic Vertebral Fracture Clinical Trial

— OSTEO-6  

Official title:

Prospective Randomized Comparative Study of Balloon Kyphoplasty,Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures of Less Than 6 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749060
• Other study ID #: P060107
• Status: Completed
• Phase: N/A
• First received: September 8, 2008
• Last updated: December 13, 2014
• Start date: December 2007
• Est. completion date: June 2012

Study information

• Verified date: December 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Between T5 and L5
• Fractures, Bone
• of Less Than 6 Weeks Duration
• Osteoporotic Vertebral Fracture
• Spinal Fractures

Intervention

Other:
• conventional treatment
with our without brace

Procedure:
• kyphoplasty with balloons
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 is injected with low pressure into the created cavity.
• vertebroplasty
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

Locations

Country	Name	City	State
France	Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Vertebral Kyphotic angle between preoperative and one-year follow-up measurements.		1 year	Yes
Secondary	1° - Pain evaluation using a visual analogic scale		J-20 à J-7 / J6 / J45 /J90 /J180 / J360	Yes
Secondary	questionnaire (Eifel) for back pain evaluation		J-20 à J-7 / J6 / J45 /J90 /J180 / J360	Yes
Secondary	Quality of life evaluation (QUALEFFO - Short-Form SF12).		J-20 à J-7 / J6 / J45 /J90 /J180 / J360	Yes
Secondary	Analgesics intake according to the WHO classification (Classes 1, 2 and 3).		J-20 à J-7 / J6 / J45 /J90 /J180 / J360	Yes
Secondary	Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle		J-20 à J-7 / J6 / J45 /J90 /J180 / J360	Yes
Secondary	Changes in anterior, mid and posterior vertebral heights of the treated vertebral body		J-20 à J-7 / J6 / J45 /J90 /J180 / J360	Yes
Secondary	Changes in height of the intervertebral disc spaces adjacent to the treated vertebra		J-20 à J-7 / J6 / J45 /J90 /J180 / J360	Yes
Secondary	Number of new vertebral fractures occurring during the one year follow-up period		J-20 à J-7 / J6 / J45 /J90 /J180 / J360	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Intensity of signal with T2 sequence		preoperative and at J360	No