Balloon Kyphoplasty Clinical Trial
— TRAUMAA3B1C1Official 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)
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.
| 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Radiologie, Hôpital Lariboisière | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Ministry of Health, France |
France,
| 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 |