Clinical trial NCT02920255: Comparison of Electronic Calipers to Conventional Calipers and X-ray Measurement of Spinal Tilt
Official title: Comparison of Electronic Caliper Measurements of Spinal Tilt to Conventional Caliper and X-ray Measurements of Spinal Tilt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lower Back Pain
Lead sponsor: KKT Orthopedic Spine Center
Sponsor class: INDUSTRY
First posted: 2016-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient Population and Normal Volunteers at KKT Orthopedic Spinal Center

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of Electronic Caliper Spinal Measurements
timeFrame: Through study completion, an average of 13 months
Secondary outcomes:
measure: Accuracy of Conventional Caliper Spinal Measurements
timeFrame: Through study completion, an average of 13 months
measure: Accuracy of X-ray Spinal Measurements
timeFrame: Through study completion, an average of 13 months
measure: Reproducibility of Electronic Caliper Measurements
timeFrame: Through study completion, an average of 13 months
measure: Reproducibility of Conventional Caliper Measurements
timeFrame: Through study completion, an average of 13 months
measure: Reproducibility of X-ray Measurements
timeFrame: Through study completion, an average of 13 months
Other outcomes:
Locations:
city: Mississauga,
country: Canada
facility: KKT Orthopedic Spine Center
state: Ontario
Study officials:
affiliation: KKT Orthopedic Spine Center
name: Aslam Khan, DC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.