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Comparison of Cervical Motion Restriction and Interface Pressure Between Two Cervical Collars

NCT04572113 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2021-08-23

No results posted yet for this study

Summary

Cervical orthoses are used to restrict motion for the purpose of preventing spinal instability following trauma or pre- and post-surgery or to protect from pain. Modern cervical orthoses are able to effectively restrict motion of the head however load is concentrated on areas of occipital tissue and may, with long term wear, lead to tissue breakdown in the form of pressure ulcers. Previous research has shown that the Miami J collar (Össur Americas Foothill Ranch, CA) effectively reduced cervical movement while providing superior pressure relief. As new cervical orthoses are developed and become commercially available it is useful to examine their performance in comparison to existing well-tested devices. DJO Global (Vista, CA) have recently developed a cervical collar. The purpose of this study is to compare the ability of this newly developed collar to restrict cervical range of motion while at the same time limit the tissue interface pressure exerted by the collar on patients when they are in an upright seated or supine position Data will be collected in a fully equipped 3D motion analysis laboratory. Cervical range of motion will be tracked and analyzed. Interface pressures between the head and collar will be measured using custom pressure mats.

Conditions

  • Cervical Pain

Interventions

DEVICE

Cervical collar

Data will be recorded while patients are not wearing or wearing one of two cervical collars

Sponsors & Collaborators

  • DJO LLC

    collaborator UNKNOWN

  • More Foundation

    lead OTHER

Principal Investigators

  • Marc Jacofsky, PhD · More Foundation

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2019-01-09
Completion
2019-11-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04572113 on ClinicalTrials.gov