NCT02920255

Brief Summary

The objective is to compare the accuracy and reproducibility of measurements taken with electronic calipers and conventional calipers. Using both calipers, reproducibility will be determined by comparing results from a number of practitioners and accuracy will be determined by comparing results with those obtained from X-rays.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

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

First Submitted

Initial submission to the registry

September 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

September 22, 2016

Last Update Submit

October 3, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Electronic Caliper Spinal Measurements

    All measurements will recorded in degrees of spinal tilt.

    Through study completion, an average of 13 months

Secondary Outcomes (5)

  • Accuracy of Conventional Caliper Spinal Measurements

    Through study completion, an average of 13 months

  • Accuracy of X-ray Spinal Measurements

    Through study completion, an average of 13 months

  • Reproducibility of Electronic Caliper Measurements

    Through study completion, an average of 13 months

  • Reproducibility of Conventional Caliper Measurements

    Through study completion, an average of 13 months

  • Reproducibility of X-ray Measurements

    Through study completion, an average of 13 months

Study Arms (3)

Electronic Caliper Measurements

This arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with electronic calipers.

Other: Diagnostic

Conventional Caliper Measurements

This arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with conventional calipers.

Other: Diagnostic

X-ray Measurements

This arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with x-rays.

Other: Diagnostic

Interventions

Measurement of spinal tilt

Conventional Caliper MeasurementsElectronic Caliper MeasurementsX-ray Measurements

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient Population and Normal Volunteers at KKT Orthopedic Spinal Center

You may qualify if:

  • Must be able to have shoulder and hip measurements for spinal tilt

You may not qualify if:

  • Not able to have shoulder and and hip measurements for spinal tilt.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KKT Orthopedic Spine Center

Mississauga, Ontario, L5M1M2, Canada

Location

Related Publications (1)

  • Akel I, Pekmezci M, Hayran M, Genc Y, Kocak O, Derman O, Erdogan I, Yazici M. Evaluation of shoulder balance in the normal adolescent population and its correlation with radiological parameters. Eur Spine J. 2008 Mar;17(3):348-354. doi: 10.1007/s00586-007-0546-0. Epub 2007 Nov 20.

    PMID: 18027001BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aslam Khan, DC

    KKT Orthopedic Spine Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 30, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

October 4, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations