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

Thoracolumbar Spine Clinical Trial

— KIPHO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02085811
• Other study ID #: THOUANT-RICOLFI AOI 2012
• Status: Recruiting
• Phase: N/A
• First received: March 5, 2014
• Last updated: March 12, 2014
• Start date: June 2013

Study information

• Verified date: June 2013
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Frederic RICOLFI
• Phone: 3.80.29.37.44
• Email: frederic.ricolfi[@]chu-dijon.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Fractures, Compression
• Thoracolumbar Spine

Intervention

Other:
• radiography standard

Locations

Country	Name	City	State
France	CHU de DIJON	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Spinal kyphosis angle		Between the post-operative period (D1) and a minimum of one year of follow-up	No
Secondary	Evaluation of pain (VAS)		At least 1 year after the kyphoplasty	No
Secondary	Number of new vertebral fractures		At least 1 year after the kyphoplasty	No
Secondary	Evaluation of quality of life (OSWESTRY and EIFEL)		At least 1 year after the kyphoplasty	No
Secondary	Evolution of the regional angle of vertebral kyphosis		At least 1 year after the kyphoplasty	No