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.
Study Type
OBSERVATIONAL
Enrollment
159
Precision Spine Care
Tyler, Texas, United States
Change from baseline VAS Sacroiliac Joint (SIJ) pain by at least 20 millimeters
A subject was considered a success if all of the following criteria were met 1\. Change from baseline VAS SIJ pain by at least 20 mm (Binary success failure composite end point) VAS is a vertical scale, where a higher score depicts more pain (100 mm maximum) and a lower scale depicts less pain (0 mm minimum)
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Absence of device related serious adverse events
A subject was considered a success if all of the following criteria were met 2\. Absence of device related serious adverse events, (Binary success failure composite end point)
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Absence of neurological worsening related to the lumbosacral nerve roots
A subject was considered a success if all of the following criteria were met 3\. Absence of neurological worsening related to the lumbosacral nerve roots, (Binary success failure composite end point)
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Absence of surgical reintervention (removal, revision reoperation or supplemental fixation) for SIJ pain
A subject was considered a success if all of the following criteria were met 4\. Absence of surgical reintervention (removal, revision reoperation or supplemental fixation) for SIJ pain (Binary success failure composite end point)
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in VAS
1\. Change in baseline in VAS from baseline at 6 months
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in ODI
2\. Change in Oswestry Disability Index at 6 months follow up ODI assesses disability and has 10 sections, each with a point range from 0 (minimum) to 5 (maximum). A higher score translates to a higher percentage, meaning more disability (100% maximum). A lower score translates to a lower percentage, meaning less disability (0% minimum).
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in PROMIS29
3\. Change in PROMIS-29 at 6 months follow up. PROMIS 29 assesses pain intensity using a 0-10 numeric rating scale (11 point scale), where a higher score equates to more pain. Other health domains are scored using a Likert scale, where higher scores represent more of the specific domain being measured.
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in Patient Global Impression of Change (PGIC)
4\. Change in Patient Satisfaction with PGIC PGIC is on a 7 point scale that depicts a patient's rating on their overall improvement. A lower score translates to a profound improvement and a higher score translates to a salvage improvement.
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
Change in Morphine milligram equivalent
5\. Change in MME usage at all time points
Time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
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