Feasibility Study of Balloon Kyphoplasty in Traumatic Vertebral Fractures Needing Surgical Fixation (TRAUMAA3B1C1)

Prospective Cohort Study on the Feasibility and Reliability of 'Open' Balloon Kyphoplasty in Types A3.2, A3.3, B1 and C1 MAGERL Classification Vertebral Fractures(STIC 4)

Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two session surgery with a first operation carried out immediately to achieve posterior fixation and a second surgery which is performed some days later to stabilize the anterior spine and restore stress resistance.

Goal of the present study is to show that percutaneous Balloon Kyphoplasty is able to restore anterior spine strength and replace second session surgery.

Study Overview

• Status: Terminated
• Conditions: One or Two Traumatic Vertebral Fractures; Located Between T11 and L5; Balloon Kyphoplasty
• Intervention / Treatment: Device: balloon kyphoplasty

Detailed Description

Patients with traumatic vertebral fractures type A3.2, A3.3, B1 and C1 of the MAGERL classification will be enrolled in this open study. They will be operated on in emergency to perform spinal canal decompression, fracture reduction and posterior fixation using fixation plates with pedicular screws combined with bone graft.

During the same surgery or some days later on, percutaneous Balloon kyphoplasty of the fractured vertebral body (ies) using polymethylmetacrylate cement injection through a posterior transpedicular approach will be carried out in replacement of anterior spine surgery to restore vertebral body strength.Patients will be followed up for one year.

Expected advantages of this management compared the conventional two session surgery include the following:

• decreased morbidity due to suppression of the anterior surgery
• improve final spine alignment and vertebral Kyphotic angle avoiding the loss in kyphotic angle which often occurs between the posterior and anterior surgery with the conventional two session surgery.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Service de Radiologie, Hôpital Lariboisière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Preliminary clinical examination (the anaesthesist must have provided his approval for the surgical procedure)
• Patient must have signed the consent form
• Male or female patient aged 18 or over
• One or two traumatic vertebral fractures located between T11 and L5 and type A3.2, A3.3, B1 or C1 in the MAGERL classification, and with a regional kyphotic angle > 15° and treated by osteosynthesis through a posterior surgical approach with or without spinal decompression
• Fracture with or without neurological difficulties
• Non tumoral origin: Confirmed by biopsy at the same time of the Balloon Kyphoplasty procedure.

Exclusion Criteria:

• Non- traumatic, malignant or osteoporotic vertebral fractures
• History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
• Known allergy to a contrast media or to one of the cement components used for kyphoplasty.
• 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.
• Vertebral fracture with loss of 90%or more of the vertebral body height
• Patient presenting a non correctable spontaneous or therapeutic coagulation disorder.
• Evolutive cardiac disease nonreactive to medical treatment
• Non compliant patient: Impossibility to participate to the study and to be followed up for 1 year.
• Pregnant or breast feeding women
• Patient not affiliated to social security

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Balloon kyphoplasty	Device: balloon kyphoplasty; During the same surgery or some days later on, percutaneous Balloon kyphoplasty of the fractured vertebral body (ies) using polymethylmetacrylate cement injection through a posterior transpedicular approach will be carried out in replacement of anterior spine surgery to restore vertebral body strength

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Loss of less than 10 degrees in spine kyphosis angle at one year follow-up after surgery compared to postoperative measurements	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Analgesics intake according to the WHO classification (Classes 1, 2 and 3).	J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements, on 3 cuts tomodensitometry (TDM) on the sagittal level : lateral right, median and lateral left	preoperative, at J6 and at J360
Pain evaluation using a visual analogic scale	J-20 to J-7 - J6 - J45 - J90 - J180 - J360
EIFEL questionnaire for back pain evaluation	J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Quality of life evaluation (SF 12).	J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle.	J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Changes in anterior, mid and posterior vertebral heights of the treated vertebral body	J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Changes in height of the intervertebral disc spaces adjacent to the treated vertebra.	J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Number of new vertebral fractures occurring during the one year follow-up period.	J-20 to J-7 - J6 - J45 - J90 - J180 - J360
Cost evaluation in a sample of 10% of patients randomly selected including the following costs : o Intervention cost.o Medical treatment costs o Consultation costs. o Hospitalization cost o Complication costs	J-20 to J-7 - J6 - J45 - J90 - J180 - J360

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Jean-Denis LAREDO, M.D.,PR., AP/HP Assistance Publique-Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: September 8, 2008
• First Submitted That Met QC Criteria: September 8, 2008
• First Posted (Estimate): September 9, 2008

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Balloon Kyphoplasty; Traumatic vertebral fracture; type A3.2, or A3.3 or B1 or C1 in the MAGERL CLASSIFICATION
• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Spinal Fractures
• Other Study ID Numbers: P060109