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

August 18, 2008
December 20, 2013
May 2006
December 2013   (final data collection date for primary outcome measure)
radiographic outcomes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00738309 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prospective Study of Scheuermann's Kyphosis
Prospective Study of Scheuermann's Kyphosis

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

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study.

Scheuermann's Kyphosis
Not Provided
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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
146
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00738309
2006HSGDEF13
No
Setting Scoliosis Straight Foundation
Setting Scoliosis Straight Foundation
DePuy Spine
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
Setting Scoliosis Straight Foundation
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP