NCT00749060

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
PROCEDURE	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

Timeline

• Start date: 2007-12-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2008-09-09
• Last updated: 2014-12-16

Locations

1 site across 1 country: France