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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Centre Hospitalier Universitaire Dijon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT02085811
First received: March 5, 2014
Last updated: March 12, 2014
Last verified: June 2013
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of pain (VAS) [ Time Frame: At least 1 year after the kyphoplasty ] [ Designated as safety issue: No ]
  • Number of new vertebral fractures [ Time Frame: At least 1 year after the kyphoplasty ] [ Designated as safety issue: No ]
  • Evaluation of quality of life (OSWESTRY and EIFEL) [ Time Frame: At least 1 year after the kyphoplasty ] [ Designated as safety issue: No ]
  • Evolution of the regional angle of vertebral kyphosis [ Time Frame: At least 1 year after the kyphoplasty ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02085811     History of Changes
Other Study ID Numbers: THOUANT-RICOLFI AOI 2012
Study First Received: March 5, 2014
Last Updated: March 12, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Fractures, Compression
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014