Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

Centre Hospitalier Universitaire de Nīmes

Status: Withdrawn

Conditions: Vertebral Body Compression Fractures

Treatments: Procedure: Kyphoplasty; Procedure: Vertebroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01402167

LOCAL/2011/PK-04

Details and patient eligibility

About

The primary objective of this study is to compare the volume of injected ciment (polymethyl methacrylate) between a group of patients treated with vertebroplasty and a group of patients treated via kyphoplasty. Secondary evaluation will compare the restoration of vertebral height, volume and cyphotic angle between the two techniques, as well as extravation of ciment and functional and quality of life aspects related to these techniques.

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 3 months of follow-up
• Fracture type according to Magerl Classification (1994) must be one of the following: A1, A2.1, A3.1, A3.2
• Cyphose of >10°
• Spinal pain
• Vertebral fracture < 3 weeks old located between D5 and L5
• If fragments in the canal, they must protrude less than 40%
• Absence of other lesions, including cancer

Exclusion criteria

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• Patient cannot read French
• Patient is pregnant or breast feeding
• Patient has a fracture on an adjacent vertebra
• Patient has a contra-indication for a treatment used in this study
• ASA class IV or V
• Patient has a neurological deficit
• Previous spinal surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Kyphoplasty

Experimental group

Description:

Patients randomized to this arm will be treated via balloon kyphoplasty.

Treatment:

Procedure: Kyphoplasty

Vertebroplasty

Active Comparator group

Description:

Patients randomized to this arm will be treated via vertebroplasty.

Treatment:

Procedure: Vertebroplasty