Kyphosis Evaluation Using SPINESCAN® | NCT01330732

Studies
Kyphosis Evaluation Using SPINESCAN®

NCT01330732

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Apr 7, 2011Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Kyphosis

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Nov 2009Estimated

Completion Date

Nov 2009Estimated

First Submitted Date

Mar 15, 2009

First Submission Date that Met QC Criteria

Apr 6, 2011

First Posted Date

Apr 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2011

Last Update Posted Date

Apr 7, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Main group: patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays.

Interventions

Not provided

Measure	Description	Time Frame
Kyphosis degree (by SPINESCAN®)		1 year

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Main group: patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays.

Age: 7 and above.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yoram Anekstein, MD	Contact	+972-57-7345403		nuritan@zahav.net.il

Overall Officials

Name	Affiliation	Role
Yigal Mirovsky, MD	Assaf-Harofeh Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf HaRofeh Medical Center		Ẕerifin		70300	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16705434	Background	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.

ID	Term
D013121	Spinal Curvatures
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases