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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02085811
First Posted: March 13, 2014
Last Update Posted: March 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
  Purpose

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.


Condition Intervention
Thoracolumbar Spine Other: radiography standard

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

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

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

Estimated Enrollment: 250
Study Start Date: June 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients Other: radiography standard

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have undergone kyphoplasty
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085811


Contacts
Contact: Frederic RICOLFI 3.80.29.37.44 ext +33 frederic.ricolfi@chu-dijon.fr

Locations
France
CHU de DIJON Recruiting
Dijon, France, 21079
Contact: Frederic RICOLFI    3.80.29.37.44 ext +33    frederic.ricolfi@chu-dijon.fr   
Contact: Pierre THOUANT    3.80.29.37.44 ext +33    pierre.thouant@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02085811     History of Changes
Other Study ID Numbers: THOUANT-RICOLFI AOI 2012
First Submitted: March 5, 2014
First Posted: March 13, 2014
Last Update Posted: March 13, 2014
Last Verified: June 2013

Keywords provided by Centre Hospitalier Universitaire Dijon:
Kyphoplasty
at a single level
(between T11 and L5)
associated surgery

Additional relevant MeSH terms:
Fractures, Compression
Kyphosis
Fractures, Bone
Wounds and Injuries
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases