Status:
COMPLETED
Comparative Study of Balloon Kyphoplasty and Conservative Treatment
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
SPINAL Fracture
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will compare two treatments in acute stable traumatic vertebral fractures (types A1, A2 and A3.1 in MAGERL Classification). The two treatments are the followings: 1. Conservative Orthopedi...
Detailed Description
There is no reported frequency of stable thoracic or lumbar fractures traumatic fractures. However, the number of cases has been evaluated to be 61,425 yearly in Europe. Types A1 and A3.1 represent 61...
Eligibility Criteria
Inclusion
- Preliminary clinical exam (the anesthetist must have provided his approval for the surgical procedure)
- Patient must have signed the consent form (ZELEN Randomization protocol)
- Male or Female, 18 years or older;
- One to three traumatic fractures, non pathological, painful, less than 10 days of age, between T11 and L5 MAGERL A1 or A2 or A3.1. all the fractures should meet the inclusion criteria(deformity, aetiology, technical possibility of doing procedure). All fractures should received the same treatment
- Thoracic vertebral Kyphosis \>15° or Lumbar vertebral Kyphosis \> 10°, or Lateral angulation \> 10°.
- Pain with VAS ≥ 5.
- The benign nature of the vertebral fracture has to be confirmed by the results of the biopsy performed during balloon kyphoplasty, or by one year follow-up in the Böhler Brace Group.
- Technical feasibility of a balloon kyphoplasty and Bohler bracing within 7 days after patient randomization.
Exclusion
- Vertebral fracture of more than 10 day duration
- Vertebral fracture not located between T11 and L5
- Vertebral fracture type different from types A1, A2 and A3.1 according to MAGERL classification.
- Thoracic vertebral Kyphosis ≤ 15° or Lumbar vertebral Kyphosis ≤ 10°, or Lateral angulation ≤ 10°.
- Osteoporotic vertebral fracture
- Association to other post traumatic fractures.
- Neurological signs or symptoms related to the vertebral fracture
- History of spine fracture, kyphoplasty, spine surgery at thoracic or lumbar levels with low back pain.
- History of surgery is not per sue a contraindication if there is no residual low back pain. However, in case of spinal fusion history, the fracture to be treated should be at minimum of two disc space from the most proximal or distal end of the fusion.
- Current infection
- Impossibility to perform the percutaneous approach of the vertebra to treat.
- Known allergy to the contrast product used during the Kyphoplasty procedure or to any of the cement components
- 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
- Malignant and traumatic vertebral fractures
- Contraindication to MRI :
- Metallic implant : pacemaker, non-movable auditive implant, metallic vascular or cardiac device Metallic surgical clips Claustrophobia
- Evolutive cardiac disease nonreactive to medical treatment
- Patient presenting a non correctable spontaneous or therapeutic coagulation disorder.
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00749242
Start Date
December 1 2007
End Date
June 1 2012
Last Update
December 16 2014
Active Locations (1)
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1
Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire
Paris, France, 75010