Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

NCT01402167 | Withdrawn

• 1 other identifier: LOCAL/2011/PK-04
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The volume (cm^3) of injected ciment

  The volume of injected ciment is measured by catscan extrapolated data.

  Baseline (Day 0)

Secondary Outcomes (32)

• Recovery of vertebral volume (%)

  Day 1 to Day 7

• Change from baseline of the cyphotic angle (°)

  Days 1 to 7

• Change from baseline of the cyphotic angle (°)

  1 month

• Change from baseline of the cyphotic angle (°)

  3 months

• Change from baseline in vertebral height (mm)

  Days 1 to 7

Study Arms (2)

Kyphoplasty

EXPERIMENTAL

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

Procedure: Kyphoplasty

Vertebroplasty

ACTIVE COMPARATOR

Patients randomized to this arm will be treated via vertebroplasty.

Procedure: Vertebroplasty

Interventions

Kyphoplasty PROCEDURE

Patients will be treated via a balloon kyphoplasty surgical procedure

Kyphoplasty

Vertebroplasty PROCEDURE

Patients will be treated via a transcutaneous vertebroplasty procedure.

Vertebroplasty

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

MeSH Terms

Interventions

Kyphoplasty; Vertebroplasty

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Pascal Kouyoumdjian, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 26, 2011
• Study Start: September 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 25, 2015

Record last verified: 2015-03