Trial record 1 of 3 for:    "Scheuermann disease"
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Prospective Study of Scheuermann's Kyphosis (PSK)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
Setting Scoliosis Straight Foundation
ClinicalTrials.gov Identifier:
NCT00738309
First received: August 18, 2008
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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


Condition
Scheuermann's Kyphosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Study of Scheuermann's Kyphosis

Resource links provided by NLM:


Further study details as provided by Setting Scoliosis Straight Foundation:

Primary Outcome Measures:
  • radiographic outcomes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical outcomes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Health related quality of life outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 146
Study Start Date: May 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Operative
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).

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738309

Locations
United States, California
UC Davis
Sacramento, California, United States, 95817
Rady Children's Hospital
San Diego, California, United States, 92123
United States, Delaware
A.I. DePont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, Florida
Miami Children's Hospital
Miami, Florida, United States, 33155
United States, Maryland
John's Hopkins Medical Institute
Baltimore, Maryland, United States, 21287-0882
United States, New Jersey
University Physicians
Camden, New Jersey, United States, 08103
United States, Ohio
Cincinnati Children's Hospital, Cincinnati, OH
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Shriners Hospital for Children
Philadelphia, Pennsylvania, United States, 19140-4131
Germany
Rehabilitationskrankenhaus Lagensteinbach
Lagensteinbach, Karlsbad, Germany
Sponsors and Collaborators
Setting Scoliosis Straight Foundation
DePuy Spine
Investigators
Principal Investigator: Baron Lonner, MD Scoliosis Associates - New York, NY
Study Director: Peter Newton, MD Rady Children's Hospital, San Diego
Study Chair: Michelle C Marks, PT, MA Harms Study Group
  More Information

No publications provided

Responsible Party: Setting Scoliosis Straight Foundation
ClinicalTrials.gov Identifier: NCT00738309     History of Changes
Other Study ID Numbers: 2006HSGDEF13
Study First Received: August 18, 2008
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Setting Scoliosis Straight Foundation:
Treatment Outcomes
Spinal Deformity
Scheuermann's Kyphosis

Additional relevant MeSH terms:
Kyphosis
Scheuermann Disease
Spinal Osteochondrosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Osteochondrosis

ClinicalTrials.gov processed this record on July 20, 2014