KyphosisNCT01330732
Kyphosis Evaluation Using SPINESCAN®
An observational study of Kyphosis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the accuracy of SPINESCAN® with standard lateral x-rays of the spine in patients monitored for kyphosis. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kyphosis
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Nov 2009
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Main group: patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays. Age: 7 and above.
Who may be able to join
- Patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays.
- Age: 7 years old and above.
Who cannot join
- Less than 7 years old.
- No informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Correlation Between Radiological Evaluation of Kyphosis and Evaluation Using SPINESCAN®
The purpose of this study is to evaluate the accuracy of SPINESCAN® with standard lateral x-rays of the spine in patients monitored for kyphosis.
Read the detailed description
Kyphosis is usually a developmental deformity of the spine in the sagittal plane. Once diagnosed, serial X-rays are used for followup. These are usually required at yearly intervals.
SPINESCAN® is a computerized digital inclinometer, design for evaluating angular spine deformities.
Patients examined in the spine clinic with recent X-rays will be examined with SPINESCAN® and it's results compared with the classical radiological assessment.
- Conditions
- Kyphosis
- Keywords
- SPINESCAN®, kyphosis
- Medical subject headings
- Kyphosis
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 |
|---|---|---|
| 1 | Main group: patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kyphosis degree (by SPINESCAN®)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startDec 2008
- Primary completionNov 2009 (estimated)
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Yigal Mirovsky, MD, Study chair, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330732
- Sponsor's protocol ID
- 109/08
- Status last verified
- Aug 2008
- First submitted
- 15 Mar 2009
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ovadia D, Bar-On E, Fragniere B, Rigo M, Dickman D, Leitner J, Wientroub S, Dubousset J. Radiation-free quantitative assessment of scoliosis: a multi center prospective study. Eur Spine J. 2007 Jan;16(1):97-105. doi: 10.1007/s00586-006-0118-8. Epub 2006 May 17.
PubMed 16705434
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Radiological Evaluation of Kyphosis and Evaluation Using SPINESCAN®
- ClinicalTrials.gov ID
- NCT01330732
- Acronym / sponsor ID
- 109/08
- Conditions
- Kyphosis
- Keywords
- SPINESCAN®, kyphosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 7 Apr 2011 (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 is to evaluate the accuracy of SPINESCAN® with standard lateral x-rays of the spine in patients monitored for kyphosis.
Detailed description
Kyphosis is usually a developmental deformity of the spine in the sagittal plane. Once diagnosed, serial X-rays are used for followup. These are usually required at yearly intervals.
SPINESCAN® is a computerized digital inclinometer, design for evaluating angular spine deformities.
Patients examined in the spine clinic with recent X-rays will be examined with SPINESCAN® and it's results compared with the classical radiological assessment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Main group: patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Main group: patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays. Age: 7 and above.
Key inclusion criteria (2 listed)
- Patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays.
- Age: 7 years old and above.
Key exclusion criteria (2 listed)
- Less than 7 years old.
- No informed consent.
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
Kyphosis degree (by SPINESCAN®)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
- Background: PubMed 16705434Ovadia D, Bar-On E, Fragniere B, Rigo M, Dickman D, Leitner J, Wientroub S, Dubousset J. Radiation-free quantitative assessment of scoliosis: a multi center prospective study. Eur Spine J. 2007 Jan;16(1):97-105. doi: 10.1007/s00586-006-0118-8. Epub 2006 May 17.
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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.
Yigal Mirovsky, MD study chair
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kyphosis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoram Anekstein, MD (+972-57-7345403, nuritan@zahav.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kyphosis degree (by SPINESCAN®) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01330732, which also lists 1 linked publication.
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 7 Apr 2011; AzTrials last refreshed its copy on 29 Oct 2026.