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Comparison of Balloon Kyphoplasty and Vertebroplasty in Subacute Osteoporotic Vertebral Fractures

NCT00749086 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2014-12-16

No results posted yet for this study

Summary

This study aims to compare two treatments in subacute (more than 6 week duration) non-traumatic (usually osteoporotic) vertebral fractures. The two treatments are the following:

1. Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement) through a posterior route through the vertebral pedicles under radiological guidance.
2. Balloon Kyphoplasty which consists of placing through a percutaneous posterior approach under radiological guidance, into the fractured vertebra a balloon which is inflated with fluid and creates a cavity. This may restore part of the vertebral height loss due to the fracture. In addition, after balloon deflation, polymethylmetacrylate cement is injected with low pressure into the created cavity to fix fracture reduction. The study will indicate if balloon kyphoplasty is able to restore vertebral height of the fractured vertebra better than vertebroplasty.

Conditions

  • Osteoporotic Vertebral Fracture
  • Between T5 and L5
  • Chronic Arthritis, Longer Than Six Weeks Duration

Interventions

DEVICE

balloon kyphoplasty

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. Then, the balloon are deflated and removed. This may restore part of the vertebral height loss due to the fracture and facilitate the injection of the cement with low pressure.

PROCEDURE

vertebroplasty

Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement) through a posterior route through the vertebral pedicles under radiological guidance

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Denis LAREDO, M.D.,PR. · AP-HP Assistance Publique- Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00749086 on ClinicalTrials.gov