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Prospective Study of Scheuermann's Kyphosis (PSK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00738309
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : April 19, 2016
Sponsor:
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
Setting Scoliosis Straight Foundation

Tracking Information
First Submitted Date August 18, 2008
First Posted Date August 20, 2008
Last Update Posted Date April 19, 2016
Study Start Date May 2006
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 19, 2008)
radiographic outcomes [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 19, 2008)
  • Clinical outcomes [ Time Frame: 2 years ]
  • Health related quality of life outcomes [ Time Frame: 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Study of Scheuermann's Kyphosis
Official Title Prospective Study of Scheuermann's Kyphosis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Scheuermann's Kyphosis
Intervention Not Provided
Study 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).
  • Non-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 was not undertaken.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 18, 2016)
147
Original Estimated Enrollment
 (submitted: August 19, 2008)
240
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00738309
Other Study ID Numbers 2006HSGDEF13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Setting Scoliosis Straight Foundation
Study Sponsor Setting Scoliosis Straight Foundation
Collaborators 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
PRS Account Setting Scoliosis Straight Foundation
Verification Date April 2016