Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

NCT ID: NCT01402167

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-08-31

Brief Summary

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.

Conditions

Vertebral Body Compression Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Kyphoplasty

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

Group Type: EXPERIMENTAL

Kyphoplasty

Intervention Type: PROCEDURE

Patients will be treated via a balloon kyphoplasty surgical procedure

Vertebroplasty

Patients randomized to this arm will be treated via vertebroplasty.

Group Type: ACTIVE_COMPARATOR

Vertebroplasty

Intervention Type: PROCEDURE

Patients will be treated via a transcutaneous vertebroplasty procedure.

Interventions

Kyphoplasty

Patients will be treated via a balloon kyphoplasty surgical procedure

Intervention Type: PROCEDURE

Vertebroplasty

Patients will be treated via a transcutaneous vertebroplasty procedure.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal Kouyoumdjian, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Other Identifiers

LOCAL/2011/PK-04

Identifier Type: -

Identifier Source: org_study_id