Prospective Study of Scheuermann's Kyphosis (PSK)
This study is enrolling participants by invitation only.
Sponsor:
Setting Scoliosis Straight Foundation
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
Setting Scoliosis Straight Foundation
ClinicalTrials.gov Identifier:
NCT00738309
First received: August 18, 2008
Last updated: July 10, 2012
Last verified: July 2012
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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: | 240 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | December 2012 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738309
Locations
| United States, California | |
| Shriners Hospital for Children | |
| Sacramento, California, United States, 95817 | |
| Rady Children's Hospital | |
| San Diego, California, United States, 92123 | |
| United States, Delaware | |
| Nemours Children's Clinic | |
| 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, 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 | |
| Childrens Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Baylor Scoliosis Center | |
| Plano, Texas, United States, 75093 | |
| 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: | July 10, 2012 |
| 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 May 23, 2013