Clinical trial NCT00738309: Prospective Study of Scheuermann's Kyphosis
Official title: Prospective Study of Scheuermann's Kyphosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scheuermann's Kyphosis
Keywords: Treatment Outcomes
Spinal Deformity
Scheuermann's Kyphosis
Lead sponsor: Setting Scoliosis Straight Foundation
Sponsor class: OTHER
Collaborators: name: DePuy Spine
First posted: 2008-08-20
Enrollment: 147
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study.

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


Eligibility criteria: 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

Primary outcomes:
measure: radiographic outcomes
timeFrame: 2 years
Secondary outcomes:
measure: Clinical outcomes
timeFrame: 2 years
measure: Health related quality of life outcomes
timeFrame: 2 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Wilmington
country: United States
facility: A.I. DePont Hospital for Children
state: Delaware
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Baltimore
country: United States
facility: John's Hopkins Medical Institute
state: Maryland
city: Camden
country: United States
facility: University Physicians
state: New Jersey
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital, Cincinnati, OH
state: Ohio
city: Philadelphia
country: United States
facility: Shriners Hospital for Children
state: Pennsylvania
city: Lagensteinbach
country: Germany
facility: Rehabilitationskrankenhaus Lagensteinbach
state: Karlsbad
Study officials:
affiliation: Scoliosis Associates - New York, NY
name: Baron Lonner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rady Children's Hospital, San Diego
name: Peter Newton, MD
role: STUDY_DIRECTOR
affiliation: Harms Study Group
name: Michelle C Marks, PT, MA
role: STUDY_CHAIR
References: