Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device

May 20, 2024 updated by: PainTEQ, LLC

A Single Arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Tyler, Texas, United States, 75701
        • Precision Spine Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Potential study participants will come from the existing patient population of the investigators in each individual practice.

Description

Inclusion Criteria:

  • Age 21-70
  • Patient has lower back pain for >6 months inadequately responsive to conservative care
  • Patient has at least 3 of 4 physical examination maneuvers specific for the SI joint (FABER, Gaenslen test, Stork/Gillete, and Yoman)
  • Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50% after injection of local anesthetic into affected SI joint(s) with confirmed arthrogram, within 30-60 min from injection
  • Degenerative sacroiliitis as SIJ mediated in in the context of either radiographic evidence of SIJ degeneration, evident on computed tomography or Xrays or a history of prior lumbar fusion.
  • SIJ disruption was defined in the study of as SIJ mediated pain in the context of asymmetric widening of SIJ on CT or Xrays or the presence of significant contrast leakage during diagnostic SIJ block
  • Baseline Oswestry Disability Index (ODI) score of at least 30%
  • Baseline Low back/buttock pain score of at least 50 on 0-100 mm visual analog scale
  • Patient has signed study-specific informed consent form
  • Patient has the necessary mental capacity to consent and participate and is physically able to comply with study protocol requirements
  • Patient has medical insurance that covers this standard of care procedure and all other anticipated and unanticipated procedure related care.
  • Patient's physician has decided that the best treatment for the patient's sacro-iliac disease is the LinQ system and the patient has agreed to the treatment.

Exclusion Criteria:

  • Inability to confirm that the pain is arising from the sacroiliac joint
  • Current severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, lumbar radicular pain, and lumbar vertebral body fracture
  • SIJ pain secondary to inflammatory conditions, Other known sacroiliac pathology such as: Sacral dysplasia, Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondylo-arthropathy), Tumor, Infection, Acute fracture, and Crystal arthropathy.
  • Radicular pain extending beyond the buttock ≥ 30mm on VAS
  • Has complete resolution of pain from the diagnostic SIJ injection lasting 30 days or more
  • Has had an injection with corticosteroid into the index SIJ within the last 90 days
  • Has had any neuraxial injection with corticosteroid within the last 90 days
  • Has greater than 50% pain relief from diagnostic medial branch blocks at the L4/5 and/or L5/S1 levels
  • Has had a sacral radiofrequency ablation within the last 6 months
  • History of any hardware placement within the sacrum or sacroiliac joint
  • History of coccydynia or coccygectomy
  • Clinical diagnosis of discogenic pain at L4/5 and/or L5/S1
  • History of endometriosis or pudendal neuralgia
  • History of recent (<1 year) major trauma to pelvis
  • Chronic rheumatologic condition (e.g., rheumatoid arthritis)
  • Any condition or anatomy that makes treatment with the Linq Implant System infeasible
  • Use of medications known to have detrimental effects on bone quality and soft-tissue healing (metabolic bone disease, induced or idiopathic)
  • Prominent neurologic condition that would interfere with physical therapy
  • Current local or systemic infection that raises the risk of surgery
  • Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
  • Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation
  • Patient with insurance coverage that does not cover the SI fusion*
  • Implanted intrathecal pain pump

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline VAS Sacroiliac Joint (SIJ) pain by at least 20 millimeters
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.

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)
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
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.

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)
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
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.

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)
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
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.

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)
Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in VAS
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.
1. Change in baseline in VAS from baseline at 6 months
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
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.
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).
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
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.
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.
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)
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.
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.
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
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.
5. Change in MME usage at all time points
Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PainTEQ, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pacific Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aaron Calodeny, MD, Precision Spine Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SECURE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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