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 (KIPHO)

March 12, 2014 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have undergone kyphoplasty

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Other: radiography standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of Spinal kyphosis angle
Time Frame: Between the post-operative period (D1) and a minimum of one year of follow-up
Between the post-operative period (D1) and a minimum of one year of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of pain (VAS)
Time Frame: At least 1 year after the kyphoplasty
At least 1 year after the kyphoplasty
Number of new vertebral fractures
Time Frame: At least 1 year after the kyphoplasty
At least 1 year after the kyphoplasty
Evaluation of quality of life (OSWESTRY and EIFEL)
Time Frame: At least 1 year after the kyphoplasty
At least 1 year after the kyphoplasty
Evolution of the regional angle of vertebral kyphosis
Time Frame: At least 1 year after the kyphoplasty
At least 1 year after the kyphoplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THOUANT-RICOLFI AOI 2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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