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

Primary Purpose

One or Two Traumatic Vertebral Fractures, Located Between T11 and L5, Balloon Kyphoplasty

Status

Terminated

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

balloon kyphoplasty

About this trial

This is an interventional prevention trial for One or Two Traumatic Vertebral Fractures focused on measuring Traumatic vertebral fracture, Balloon Kyphoplasty, type A3.2, or A3.3 or B1 or C1 in the MAGERL CLASSIFICATION

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Service de Radiologie, Hôpital Lariboisière

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm Description

Balloon kyphoplasty

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain evaluation using a visual analogic scale

EIFEL questionnaire for back pain evaluation

Quality of life evaluation (SF 12).

Analgesics intake according to the WHO classification (Classes 1, 2 and 3).

Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle.

Changes in anterior, mid and posterior vertebral heights of the treated vertebral body

Changes in height of the intervertebral disc spaces adjacent to the treated vertebra.

Number of new vertebral fractures occurring during the one year follow-up period.

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

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

Full Information

NCT ID

NCT00749229

First Posted

September 8, 2008

Last Updated

January 3, 2017

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France

1. Study Identification

Unique Protocol Identification Number

NCT00749229

Brief Title

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

Acronym

TRAUMAA3B1C1

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Terminated

Why Stopped

the number of patients recruited at present is sufficient for analysis.

Study Start Date

December 2007 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

One or Two Traumatic Vertebral Fractures, Located Between T11 and L5, Balloon Kyphoplasty

Keywords

Traumatic vertebral fracture, Balloon Kyphoplasty, type A3.2, or A3.3 or B1 or C1 in the MAGERL CLASSIFICATION

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Balloon kyphoplasty

Intervention Type

Device

Intervention Name(s)

balloon kyphoplasty

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Pain evaluation using a visual analogic scale

Time Frame