NCT01330732

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
Last Updated

April 7, 2011

Status Verified

August 1, 2008

Enrollment Period

11 months

First QC Date

March 15, 2009

Last Update Submit

April 6, 2011

Conditions

Keywords

SPINESCAN®kyphosis

Outcome Measures

Primary Outcomes (1)

  • Kyphosis degree (by SPINESCAN®)

    1 year

Study Arms (1)

1

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

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Main group: patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays. Age: 7 and above.

You may qualify if:

  • Patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays.
  • Age: 7 years old and above.

You may not qualify if:

  • Less than 7 years old.
  • No informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf HaRofeh Medical Center

Ẕerifin, 70300, Israel

Location

Related Publications (1)

  • 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.

    PMID: 16705434BACKGROUND

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Yigal Mirovsky, MD

    Assaf-Harofeh Medical Center

    STUDY CHAIR

Central Study Contacts

Yoram Anekstein, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 15, 2009

First Posted

April 7, 2011

Study Start

December 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

April 7, 2011

Record last verified: 2008-08

Locations