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Prospective Study of Scheuermann's Kyphosis (PSK)

S

Setting Scoliosis Straight Foundation

Status

Completed

Conditions

Scheuermann's Kyphosis

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00738309
2006HSGDEF13

Details and patient eligibility

About

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

Enrollment

147 patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

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

Trial design

147 participants in 2 patient groups

Operative
Description:
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
Description:
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.

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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