Prospective Study of Scheuermann's Kyphosis

Scheuermann's Kyphosis Clinical Trial

— PSK  

Official title:

Prospective Study of Scheuermann's Kyphosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738309
• Other study ID #: 2006HSGDEF13
• Status: Completed
• Phase: N/A
• First received: August 18, 2008
• Last updated: April 18, 2016
• Start date: May 2006
• Est. completion date: December 2013

Study information

• Verified date: April 2016
• Source: Setting Scoliosis Straight Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study to determine the radiographic and clinical outcomes of spinal deformity surgical treatment in patients with Scheuermann's Kyphosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• Patient age < 21 years

• Male or female

• Diagnosis of classical Scheuermann's Kyphosis (3 successive vertebrae wedged 5 degrees or more, +/- end plate deformities) or idiopathic structural Kyphosis (rigid structural kyphosis without classic Scheuermann's Kyphosis findings).

• for which surgical treatment is recommended to prevent progression of the curvature or to correct trunk deformity (unacceptable cosmesis) - any deformity magnitude.

OR

• for which surgical treatment is not being undertaken (and alternate treatment, i.e. bracing, or observation) is being pursued for any curve magnitude of clinical concerns of Scheuermann's Kyphosis.

• Inclusion Criteria for Anterior Release (for those surgeons performing anterior release surgery): Deformity magnitude = any degree and any other criteria defined by the individual surgeon.

• Posterior disc herniation is not an exclusion criteria from being in the study, only from being in the Posterior surgery group - these patients will be defaulted to Ant/Post Surgery.

• Only patients that have had a pre-op MRI performed as a part of their routine care, should be included in this study.

Exclusion Criteria:

• Previous operated Kyphosis, Scoliosis or Spondylolisthesis

• Neuromuscular co-morbidity

• Post laminectomy kyphosis

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kyphosis
• Scheuermann Disease
• Scheuermann's Kyphosis
• Spinal Osteochondrosis

Locations

Country	Name	City	State
Germany	Rehabilitationskrankenhaus Lagensteinbach	Lagensteinbach	Karlsbad
United States	John's Hopkins Medical Institute	Baltimore	Maryland
United States	University Physicians	Camden	New Jersey
United States	Cincinnati Children's Hospital, Cincinnati, OH	Cincinnati	Ohio
United States	Miami Children's Hospital	Miami	Florida
United States	Shriners Hospital for Children	Philadelphia	Pennsylvania
United States	UC Davis	Sacramento	California
United States	Rady Children's Hospital	San Diego	California
United States	A.I. DePont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Setting Scoliosis Straight Foundation	DePuy Spine

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiographic outcomes		2 years	Yes
Secondary	Clinical outcomes		2 years	Yes
Secondary	Health related quality of life outcomes		2 years	No