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 range

18 Years

Sex

ALL

See this in plain English?

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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