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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02920255
Other study ID # Caliper 1001
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 22, 2016
Last updated October 3, 2016
Start date October 2016
Est. completion date November 2017

Study information

Verified date October 2016
Source KKT Orthopedic Spine Center
Contact Aslam Khan, DC
Phone 1-905-285-0005
Email drkhan@kktspinetreatment.com
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial 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.


Description:

Participants will have 2 spinal measurements, one at the shoulder and one at the hip, taken by electronic calipers and conventional calipers with different individual research staff. Up to 5 individual research staff will take the 2 spinal measurements on each participant. This will be done to compare variation of measurements between individual operators.

The accuracy of the spinal measurements, obtained with electronic and conventional calipers will be compared to the results obtained from x-rays taken of shoulder and hip areas. Only one x-ray of the shoulder and one x-ray of the hip will be taken of each participant. X-rays represent the clinically accepted standard of obtaining spinal measurements.

The data will analyzed statistically to determine sources of variation among the methods of spinal measurement described above.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria

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

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Diagnostic
Measurement of spinal tilt

Locations

Country Name City State
Canada KKT Orthopedic Spine Center Mississauga, Ontario

Sponsors (1)

Lead Sponsor Collaborator
KKT Orthopedic Spine Center

Country where clinical trial is conducted

Canada, 

References & 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):348-54. Epub 2007 Nov 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of Electronic Caliper Spinal Measurements All measurements will recorded in degrees of spinal tilt. Through study completion, an average of 13 months No
Secondary Accuracy of Conventional Caliper Spinal Measurements All measurements will recorded in degrees of spinal tilt. Through study completion, an average of 13 months No
Secondary Accuracy of X-ray Spinal Measurements All measurements will recorded in degrees of spinal tilt. Through study completion, an average of 13 months No
Secondary Reproducibility of Electronic Caliper Measurements All measurements will recorded in degrees of spinal tilt. Through study completion, an average of 13 months No
Secondary Reproducibility of Conventional Caliper Measurements All measurements will recorded in degrees of spinal tilt. Through study completion, an average of 13 months No
Secondary Reproducibility of X-ray Measurements All measurements will recorded in degrees of spinal tilt. Through study completion, an average of 13 months No
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