Kyphosis Evaluation Using SPINESCAN®
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Assaf-Harofeh Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Assaf-Harofeh Medical Center
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01330732
First received: March 15, 2009
Last updated: April 6, 2011
Last verified: August 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 15, 2009 | ||||
| Last Updated Date | April 6, 2011 | ||||
| Start Date ICMJE | December 2008 | ||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Kyphosis degree (by SPINESCAN®) [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01330732 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Kyphosis Evaluation Using SPINESCAN® | ||||
| Official Title ICMJE | The Correlation Between Radiological Evaluation of Kyphosis and Evaluation Using SPINESCAN® | ||||
| Brief 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. |
||||
| 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 Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Main group: patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays. Age: 7 and above. |
||||
| Condition ICMJE | Kyphosis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1
Main group: patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays. |
||||
| Publications * | Ovadia D, Bar-On E, Fragnière 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. Epub 2006 May 17. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | November 2009 | ||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 7 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01330732 | ||||
| Other Study ID Numbers ICMJE | 109/08 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Yoram Anekstein, MD, Assaf-Harofeh Medical Center | ||||
| Study Sponsor ICMJE | Assaf-Harofeh Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Assaf-Harofeh Medical Center | ||||
| Verification Date | August 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||