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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00749229
Other study ID # P060109
Secondary ID
Status Terminated
Phase Phase 4
First received September 8, 2008
Last updated January 3, 2017
Start date December 2007
Est. completion date March 2011

Study information

Verified date December 2014
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 17
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Service de Radiologie, Hôpital Lariboisière Paris

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Loss of less than 10 degrees in spine kyphosis angle at one year follow-up after surgery compared to postoperative measurements 1 year Yes
Secondary Pain evaluation using a visual analogic scale J-20 to J-7 - J6 - J45 - J90 - J180 - J360 Yes
Secondary EIFEL questionnaire for back pain evaluation J-20 to J-7 - J6 - J45 - J90 - J180 - J360 Yes
Secondary Quality of life evaluation (SF 12). J-20 to J-7 - J6 - J45 - J90 - J180 - J360 No
Secondary Analgesics intake according to the WHO classification (Classes 1, 2 and 3). J-20 to J-7 - J6 - J45 - J90 - J180 - J360 Yes
Secondary Regional spine Kyphosis angle and global thoracic and lumbar Kyphosis angle. J-20 to J-7 - J6 - J45 - J90 - J180 - J360 No
Secondary Changes in anterior, mid and posterior vertebral heights of the treated vertebral body J-20 to J-7 - J6 - J45 - J90 - J180 - J360 No
Secondary Changes in height of the intervertebral disc spaces adjacent to the treated vertebra. J-20 to J-7 - J6 - J45 - J90 - J180 - J360 No
Secondary Number of new vertebral fractures occurring during the one year follow-up period. J-20 to J-7 - J6 - J45 - J90 - J180 - J360 Yes
Secondary 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 Yes
Secondary 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 No