Kyphosis Evaluation Using SPINESCAN®

Kyphosis Clinical Trial

Official title:

The Correlation Between Radiological Evaluation of Kyphosis and Evaluation Using SPINESCAN®

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01330732
• Other study ID #: 109/08
• Status: Not yet recruiting
• Phase: N/A
• First received: March 15, 2009
• Last updated: April 6, 2011
• Start date: December 2008
• Est. completion date: November 2009

Study information

• Verified date: August 2008
• Source: Assaf-Harofeh Medical Center
• Contact: Yoram Anekstein, MD
• Phone: +972-57-7345403
• Email: nuritan[@]zahav.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• Patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays.

• Age: 7 years old and above.

Exclusion Criteria:

• Less than 7 years old.

• No informed consent.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kyphosis

Locations

Country	Name	City	State
Israel	Assaf HaRofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kyphosis degree (by SPINESCAN®)		1 year	No