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Completed

NCT Number: NCT00738309

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.

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Key information

Conditions

Scheuermann's Kyphosis Bone Diseases Kyphosis Musculoskeletal Diseases Osteochondrosis Scheuermann Disease Spinal Curvatures Spinal Diseases Spinal Osteochondrosis

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rehabilitationskrankenhaus Lagensteinbach, Lagensteinbach, Karlsbad, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. radiographic outcomes

    Time frame: 2 years

Secondary outcomes

  1. Clinical outcomes

    Time frame: 2 years

  2. Health related quality of life outcomes

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Setting Scoliosis Straight Foundation

Other

Collaborators

  • DePuy Spine

Registry information

Acronym: PSK

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Aug 20, 2008
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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