Clinical Trials Directory

Trials / Completed

CompletedNCT02904681

Multicenter Retrospective Evaluation of the Surgical Management of Spinal Growth Dystrophy

Status
Completed
Phase
Study type
Observational
Enrollment
16 (actual)
Sponsor
Fondation Hôpital Saint-Joseph · Academic / Other
Sex
All
Age
10 Years
Healthy volunteers
Not accepted

Summary

Spinal growth dystrophy (CRD), also called Scheuermann's disease, corresponding to impaired vertebral structure occurring in children and adolescents with involvement of the growth cartilage causing impaired growth and kyphosis. There are forms thoracolumbar and thoracic conventional forms of DRC with variable clinical expressions; the most important being kyphosis with spinal stiffness associated with painful elements. The radiographic definition according Sorenson is uniformisation 5 ° affecting at least three adjacent vertebrae. Scheuermann's disease and three problems. First, the thoracic kyphosis generates back pain which may be thoracic or lumbar indirectly attributed to compensatory lordosis. Moreover disruption sagittal balance frequently causes a significant aesthetic discomfort. Finally, scalability because the curvature may increase the likelihood of degenerative lesions disc degeneration or lumbar spinal stenosis for example. When the disease is diagnosed early, treatment is most often associated with orthopedic physiotherapy. However, for patients with active deformation, despite an orthopedic brace treatment with chronic pain, neurological deficit or for aesthetic reasons, surgical decision can be taken. The goal of surgical treatment of DRC is a correction of the thoracic kyphosis. It goes through a spinal fusion must be released from his column stiffness in a bad position, changing the equilibrium profile and ensure that it remains in a good position. This surgery usually requires a prior operative time (thoracic surgery to remove the intervertebral discs) and a posterior surgical time (blockage of the vertebrae together with a bone graft and osteosynthesis). Currently different surgical strategies are practiced there is no real consensus between the teams.

Detailed description

objectives: 1. Evaluation of the rate and type of complications in different age categories and surgical strategies. 2. Evaluation of clinical results based on surgical strategies. 3. Evaluation of sagittal balance and correction obtained based surgical strategies Methodology and duration of the research This is a multicenter retrospective cohort on the assessment of surgical practices cited objectives. Also, this research is in Chapter X of the Data Protection Act and allows the collection of personal data for the purpose of evaluation of care and prevention practices with authorization request to the CNIL; the opinion of CCTIRS therefore not required in this case. This study concerns the data of patients operated with the techniques mentioned in addition with a decline of more than 20 years. Patients are aware of the potential use of their data in their files for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery and most recently contained in the Home booklet setting for patients. Nature of the data collected The data is anonymous and not identifiable (for each subject a number of inclusion is given). The name of the surgeon is also anonymized. The data collected concern the characteristics of the patient, as well as its history, the operating data including technical, suites and possible post-operative complications and patient monitoring. Data collection will be done on the basis KEOPS https://www.keops-spine.fr

Conditions

Interventions

TypeNameDescription
OTHERNo intervention. Observational and descriptive study

Timeline

Start date
2014-12-01
Primary completion
2015-01-30
Completion
2016-04-15
First posted
2016-09-19
Last updated
2017-09-06

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02904681. Inclusion in this directory is not an endorsement.