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Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device

NCT04423120 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 159

Last updated 2024-05-22

No results posted yet for this study

Summary

The PainTEQ study is a prospective, multi-site, prospective, single arm study intended to collect clinical data outcomes data associated with the treatment of sacroiliac disease with the LinQ fusion procedure. Data will be collected using self-report measures including the visual analog scale (VAS) for pain assessment where the participant is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Other self-report questionnaires will be administered including the Oswestry Disablity Index (ODI) to measure low-back pain and disability, and the Patient-Reported Outcomes Measurement Information System 29 (PROMIS 29) to measure physical, mental, and social health and well-being.

Conditions

Sponsors & Collaborators

  • Pacific Research Institute

    collaborator NETWORK

  • PainTEQ, LLC

    lead INDUSTRY

Principal Investigators

  • Aaron Calodeny, MD · Precision Spine Care

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-13
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04423120 on ClinicalTrials.gov