Multicenter Retrospective Evaluation of the Surgical Management of Spinal Growth Dystrophy
DRC
1 other identifier
observational
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2016
CompletedFirst Submitted
Initial submission to the registry
August 31, 2016
CompletedFirst Posted
Study publicly available on registry
September 19, 2016
CompletedSeptember 6, 2017
September 1, 2017
2 months
August 31, 2016
September 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Surgery complication type
Statement from the database keops
Day 30
Secondary Outcomes (3)
Assessment od the clinical results based on surgical strategies
Day 30
Assessment of sagittal balance and correction Score obtained
Day 30
Assessment of correction Score obtained
Day 30
Interventions
Eligibility Criteria
Patients operated on for an arthrodesis Dystrophy Spinal Growth (DRC)
You may qualify if:
- patients operated on for an arthrodesis Dystrophy Spinal Growth (DRC)
- Age\> 10 years
- monitoring of minimum one year
You may not qualify if:
- deformation in the frontal plane
- kyphosis malformation
- osteoporotic or degenerative kyphosis
- post laminectomy kyphosis
- constitutional bone disease
- connective Tissue Disease
- myopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2016
First Posted
September 19, 2016
Study Start
December 1, 2014
Primary Completion
January 30, 2015
Study Completion
April 15, 2016
Last Updated
September 6, 2017
Record last verified: 2017-09