Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine

NCT ID: NCT02085811

Last Updated: 2014-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thoracolumbar Spine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients

radiography standard

Intervention Type OTHER

Interventions

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radiography standard

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de DIJON

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Frederic RICOLFI

Role: CONTACT

3.80.29.37.44 ext. +33

Facility Contacts

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Frederic RICOLFI

Role: primary

3.80.29.37.44 ext. +33

Pierre THOUANT

Role: backup

3.80.29.37.44 ext. +33

Other Identifiers

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THOUANT-RICOLFI AOI 2012

Identifier Type: -

Identifier Source: org_study_id

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