NCT02904681

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

2 months

First QC Date

August 31, 2016

Last Update Submit

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

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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

Locations