CompletedPhase 4

Comparative Study of Balloon Kyphoplasty and Conservative Treatment

France41 participantsStarted 2007-12

Plain-language 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 Orthopedic Management consisting of brace and pain medication. 2. Percutaneous Balloon Kyphoplasty, a variant of Vertebroplasty, in which a balloon is first placed into the fractured vertebra and inflated with fluid in order to create a cavity. This may restore part of the vertebral height loss due to the fracture and facilitate the injection of the cement with low pressure. The primary outcome will be the variation in the angle of Regional Vertebral Kyphosis (or, in the case of asymmetrical fractures, the angle of lateral vertebral inclination) between inclusion and one year follow-up. It will indicate if Balloon Kyphoplasty is able to restore vertebral height of the fractured vertebra better than Conservative Orthopedic Management.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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 …

What they're measuring

The primary outcome is the variation of the angle of Vertebral Kyphosis or, in the case of asymmetrical fractures, the angle of lateral vertebral inclination between inclusion and one year follow-up examination

Timeframe: 1 year

Trial details

NCT IDNCT00749242

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-06