Prospective Study of Scheuermann's Kyphosis (PSK)

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

Study Overview

• Status: Completed
• Conditions: Scheuermann's Kyphosis

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• Germany
  • Karlsbad
    • Lagensteinbach, Karlsbad, Germany
      • Rehabilitationskrankenhaus Lagensteinbach
• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • A.I. DePont Hospital for Children
  • Florida
    • Miami, Florida, United States, 33155
      • Miami Children's Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21287-0882
      • John's Hopkins Medical Institute
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • University Physicians
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital, Cincinnati, OH
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140-4131
      • Shriners Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
radiographic outcomes	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical outcomes	2 years
Health related quality of life outcomes	2 years

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 18, 2008
• First Submitted That Met QC Criteria: August 19, 2008
• First Posted (Estimate): August 20, 2008

Study Record Updates

• Last Update Posted (Estimate): April 19, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Treatment Outcomes; Spinal Deformity; Scheuermann's Kyphosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Osteochondrosis; Kyphosis; Scheuermann Disease; Spinal Osteochondrosis
• Other Study ID Numbers: 2006HSGDEF13