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Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures | Clinical Trials | Clareo Health

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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

NCT00749060•Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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
+11 more criteria

Locations (1)

Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire

Paris, France

Key Dates

Start Date

December 1, 2007

Primary Completion Date

June 1, 2012

Completion Date

June 1, 2012

Last Updated

December 16, 2014

Enrollment

ACTUAL participants

Conditions

Osteoporotic Vertebral FractureBetween T5 and L5of Less Than 6 Weeks Duration

Interventions

conventional treatment

OTHER

kyphoplasty with balloons

PROCEDURE

vertebroplasty

PROCEDURE

Construction and Validation of a Risk Prediction Model for Secondary Vertebral Fracture in Patients With Osteoporotic Vertebral Compression Fractures After Percutaneous Vertebroplasty

NCT06172179

Osteoporotic Vertebral FracturePrediction Model

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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