NCT00738309

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

7.6 years

First QC Date

August 18, 2008

Last Update Submit

April 18, 2016

Conditions

Scheuermann's Kyphosis

Keywords

Treatment OutcomesSpinal DeformityScheuermann's Kyphosis

Outcome Measures

Primary Outcomes (1)

  • radiographic outcomes

    2 years

Secondary Outcomes (2)

  • Clinical outcomes

    2 years

  • Health related quality of life outcomes

    2 years

Study Arms (2)

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.

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • Only patients that have had a pre-op MRI performed as a part of their routine care, should be included in this study.
  • Previous operated Kyphosis, Scoliosis or Spondylolisthesis
  • Neuromuscular co-morbidity
  • Post laminectomy kyphosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UC Davis

Sacramento, California, 95817, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

A.I. DePont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

John's Hopkins Medical Institute

Baltimore, Maryland, 21287-0882, United States

Location

University Physicians

Camden, New Jersey, 08103, United States

Location

Cincinnati Children's Hospital, Cincinnati, OH

Cincinnati, Ohio, 45229, United States

Location

Shriners Hospital for Children

Philadelphia, Pennsylvania, 19140-4131, United States

Location

Rehabilitationskrankenhaus Lagensteinbach

Lagensteinbach, Karlsbad, Germany

Location

MeSH Terms

Conditions

Scheuermann Disease

Condition Hierarchy (Ancestors)

Spinal OsteochondrosisOsteochondrosisBone DiseasesMusculoskeletal DiseasesKyphosisSpinal CurvaturesSpinal Diseases

Study Officials

  • Baron Lonner, MD

    Scoliosis Associates - New York, NY

    PRINCIPAL INVESTIGATOR

  • Peter Newton, MD

    Rady Children's Hospital, San Diego

    STUDY DIRECTOR

  • Michelle C Marks, PT, MA

    Harms Study Group

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

May 1, 2006

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

DE(1)US(8)