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

This study has been terminated.
(the number of patients recruited at present is sufficient for analysis.)
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00749229
First received: September 8, 2008
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
One or Two Traumatic Vertebral Fractures
Located Between T11 and L5,
Balloon Kyphoplasty
Device: balloon kyphoplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain evaluation using a visual analogic scale [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: Yes ]
  • EIFEL questionnaire for back pain evaluation [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: Yes ]
  • Quality of life evaluation (SF 12). [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: No ]
  • Analgesics intake according to the WHO classification (Classes 1, 2 and 3). [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: Yes ]
  • Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle. [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: No ]
  • Changes in anterior, mid and posterior vertebral heights of the treated vertebral body [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: No ]
  • Changes in height of the intervertebral disc spaces adjacent to the treated vertebra. [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: No ]
  • Number of new vertebral fractures occurring during the one year follow-up period. [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: J-20 to J-7 - J6 - J45 - J90 - J180 - J360 ] [ Designated as safety issue: Yes ]
  • Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements, on 3 cuts TDM on the sagittal level : lateral right, median and lateral left [ Time Frame: preoperative, at J6 and at J360 ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: December 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749229

Locations
France
Service de Radiologie, Hôpital Lariboisière
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Jean-Denis LAREDO, M.D.,PR. AP/HP Assistance Publique-Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00749229     History of Changes
Other Study ID Numbers: P060109
Study First Received: September 8, 2008
Last Updated: November 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Traumatic vertebral fracture
Balloon Kyphoplasty
type A3.2, or A3.3 or B1 or C1 in the MARGERL CLASSIFICATION

Additional relevant MeSH terms:
Fractures, Bone
Spinal Fractures
Wounds and Injuries
Spinal Injuries
Back Injuries

ClinicalTrials.gov processed this record on August 19, 2014