Scheuermann's KyphosisPSKNCT00738309
Prospective Study of Scheuermann's Kyphosis
An observational study of Scheuermann's Kyphosis, run by Setting Scoliosis Straight Foundation at 9 sites in 2 countries.
Trial summary
The purpose of this study to determine the radiographic and clinical outcomes of spinal deformity surgical treatment in patients with Scheuermann's Kyphosis. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Scheuermann's Kyphosis
- How many people
- 147 participants
- Where
- 9 sitesin 2 countries
- Study dates
- May 2006to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study.
Who may be able to join
- 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.
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- 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.
Who cannot join
- Previous operated Kyphosis, Scoliosis or Spondylolisthesis
- Neuromuscular co-morbidity
- Post laminectomy kyphosis
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
John's Hopkins Medical Institute
Baltimore, Maryland, 21287-0882
University Physicians
Camden, New Jersey, 08103
Cincinnati Children's Hospital, Cincinnati, OH
Cincinnati, Ohio, 45229
Miami Children's Hospital
Miami, Florida, 33155
Shriners Hospital for Children
Philadelphia, Pennsylvania, 19140-4131
UC Davis
Sacramento, California, 95817
Rady Children's Hospital
San Diego, California, 92123
A.I. DePont Hospital for Children
Wilmington, Delaware, 19803
Germany1 site
Rehabilitationskrankenhaus Lagensteinbach
Lagensteinbach, Karlsbad
About this study
The purpose of this study to determine the radiographic and clinical outcomes of spinal deformity surgical treatment in patients with Scheuermann's Kyphosis.
- Conditions
- Scheuermann's Kyphosis
- Keywords
- Treatment Outcomes, Spinal Deformity, Scheuermann's Kyphosis
- Medical subject headings
- Scheuermann Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
radiographic outcomes
Measured: 2 years
Secondary outcomes (2)
Clinical outcomes
Measured: 2 years
Health related quality of life outcomes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startMay 2006
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scheuermann's KyphosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Setting Scoliosis Straight Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Spine
- Responsible party
- Sponsor
- Investigators
- Baron Lonner, MD, Principal investigator, Scoliosis Associates - New York, NYPeter Newton, MD, Study director, Rady Children's Hospital, San DiegoMichelle C Marks, PT, MA, Study chair, Harms Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738309
- Sponsor's protocol ID
- 2006HSGDEF13
- Acronym
- PSK
- Status last verified
- Apr 2016
- First submitted
- 18 Aug 2008
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Scheuermann's Kyphosis
- ClinicalTrials.gov ID
- NCT00738309
- Acronym / sponsor ID
- PSK / 2006HSGDEF13
- Conditions
- Scheuermann's Kyphosis
- Keywords
- Treatment Outcomes, Spinal Deformity, Scheuermann's Kyphosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Setting Scoliosis Straight FoundationUniversity, hospital or other
- Collaborators
- DePuy Spine
- Study start
- May 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study to determine the radiographic and clinical outcomes of spinal deformity surgical treatment in patients with Scheuermann's Kyphosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Previous operated Kyphosis, Scoliosis or Spondylolisthesis
- Neuromuscular co-morbidity
- Post laminectomy kyphosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
radiographic outcomes
Time frame: 2 years
2 secondary outcomes
Clinical outcomes
Time frame: 2 years
Health related quality of life outcomes
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baron Lonner, MD principal investigator
Scoliosis Associates - New York, NY
Peter Newton, MD study director
Rady Children's Hospital, San Diego
Michelle C Marks, PT, MA study chair
Harms Study Group
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scheuermann's Kyphosis, run by Setting Scoliosis Straight Foundation at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic outcomes (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.