NCT02085811

Brief Summary

The aim of this retrospective study is to show that kyphoplasty is a reliable technique in the treatment of certain traumatic vertebral fractures. Patients will be selected from medical records archived at the Neuroradiology Department of Dijon CHU. An information sheet and questionnaire will be sent to patients together with a letter to ask them to have a radiographic examination. The radiographic images will be interpreted by two independent experts to evaluate the angle pf vertebral kyphosis.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Last Updated

March 13, 2014

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

March 5, 2014

Last Update Submit

March 12, 2014

Conditions

Thoracolumbar Spine

Keywords

Kyphoplastyat a single level(between T11 and L5)associated surgery

Outcome Measures

Primary Outcomes (1)

  • Measure of Spinal kyphosis angle

    Between the post-operative period (D1) and a minimum of one year of follow-up

Secondary Outcomes (4)

  • Evaluation of pain (VAS)

    At least 1 year after the kyphoplasty

  • Number of new vertebral fractures

    At least 1 year after the kyphoplasty

  • Evaluation of quality of life (OSWESTRY and EIFEL)

    At least 1 year after the kyphoplasty

  • Evolution of the regional angle of vertebral kyphosis

    At least 1 year after the kyphoplasty

Study Arms (1)

Patients

Other: radiography standard

Interventions

radiography standardOTHER
Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have undergone kyphoplasty

You may qualify if:

  • Men or women aged at least 18;
  • who underwent Kyphoplasty between T11 and L5,
  • Patients who had Kyphoplasty at a single level without associated surgery,
  • Magerl type-A fracture.
  • Non-tumoral and non-osteoporotic cause.

You may not qualify if:

  • Compression fracture outside the T11-L5 segment, or fracture other than Magerl type A.
  • Osteoporotic vertebral fracture
  • Association with other post-traumatic fractures.
  • History of Balloon Kyphoplasty, or of thoracic or lumbar spine surgery except simple discectomy.
  • Pregnant or breast-feeding women
  • Patients not covered by national health insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de DIJON

Dijon, 21079, France

RECRUITING

Central Study Contacts

Frederic RICOLFI

CONTACT

3.80.29.37.44frederic.ricolfi@chu-dijon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 13, 2014

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Last Updated

March 13, 2014

Record last verified: 2013-06

Locations

FR(1)