LINQ® Procedure for Sacroiliitis
(LINQT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess the safety and effectiveness of the LINQ fusion procedure for treating sacroiliac joint (SIJ) dysfunction, which causes pain in the lower back and buttock area. Researchers will divide participants into two groups: one will undergo the LINQ procedure, while the other will follow standard non-surgical treatments. The trial seeks individuals who have experienced significant lower back or buttock pain for at least six months and have been diagnosed with SIJ dysfunction. As a Phase 4 trial, the LINQ procedure is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.
What is the safety track record for the LINQ fusion procedure?
Research has shown that the LINQ fusion procedure is generally safe for treating sacroiliac joint (SIJ) problems. In one study, no patients experienced negative side effects or complications after the procedure. Another review noted that while rare issues like implant misplacement can occur, further surgery is usually only necessary if significant new pain arises. Overall, studies report positive outcomes, including pain relief and improved movement. Patients express greater satisfaction with the LINQ procedure compared to non-surgical treatments, indicating that most handle it well.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about the LINQ fusion procedure for sacroiliitis because it offers a minimally invasive alternative to traditional treatments like physical therapy, medication, and more extensive surgeries. Unlike conventional methods that often require long recovery times or ongoing management of symptoms, the LINQ procedure aims to directly stabilize the sacroiliac joint using a small implant. This approach could potentially reduce pain more effectively and shorten recovery periods, making it a promising option for patients suffering from SIJ pain.
What evidence suggests that the LINQ fusion procedure is effective for sacroiliitis?
Research has shown that the LINQ fusion procedure effectively treats sacroiliac joint (SIJ) problems. This minimally invasive procedure involves less cutting and shorter recovery time. In this trial, participants in the Treatment Arm will undergo the LINQ Procedure. Studies have found that it significantly reduces pain and improves mobility over time. Specifically, one study reported a substantial pain reduction, with an average improvement of 55.4 points after two years. Another study found that it stabilized the joint by reducing unwanted movement. Overall, the LINQ procedure significantly improves the quality of life for most people with SIJ issues.56789
Are You a Good Fit for This Trial?
This trial is for adults aged 21 or older with a BMI of 40 or less who have had lower back or buttock pain from sacroiliac joint (SIJ) dysfunction for at least 6 months, haven't improved with non-surgical treatments, and meet specific tests confirming SIJ problems.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Baseline Procedure
Participants are randomized to either the LINQ Procedure or Conventional Medical Management (CMM) and undergo the baseline procedure or initiation of CMM
Treatment
Participants receive either the LINQ Procedure or continue with CMM. Follow-up visits occur through 24 months
Crossover (optional)
Participants in the Control Group may opt to crossover to receive the LINQ procedure after the 6 Month evaluation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LINQ fusion procedure
Trial Overview
The study compares the LINQ fusion procedure—a minimally invasive surgery using bone grafts—to standard non-surgical care (like physical therapy and medications) to see which works better for treating sacroiliac joint pain.
How Is the Trial Designed?
2
Treatment groups
Active Control
Subjects randomized to the CMM Control Arm shall receive standardized, stepwise, non-surgical management for SIJ pain.
Subjects randomized to the Treatment Arm will undergo the LINQ Procedure.
Find a Clinic Near You
Who Is Running the Clinical Trial?
PainTEQ, LLC
Lead Sponsor
Citations
Minimally Invasive Posterior SI Joint Fusion with a Novel ...
The results indicate that posterior SI joint fusion is safe and effective at achieving sustained pain relief. Our findings are congruent with ...
2.
researchgate.net
researchgate.net/publication/390989849_Efficacy_and_Safety_of_Posterior_Minimally_Invasive_Sacroiliac_Joint_Fusion_A_Narrative_Review_of_Recent_EvidenceEfficacy and Safety of Posterior Minimally Invasive ...
Jin SI fusion reduced pain and disability as measured by Visual Analog Scale and Oswestry Index and improved quality of life. MIS SI fusion is ...
Biomechanical Evaluation of Novel Posterior Approach to ...
The results revealed that LinQ significantly reduced ROM in flexion/extension, axial rotations, and lateral bends, resulting in increased ...
Comparative Outcomes of Posterior and Lateral Sacroiliac ...
Two-year outcomes from a randomized controlled trial of minimally invasive sacroiliac joint fusion vs. non-surgical management for sacroiliac joint dysfunction.
5.
spoc-ortho.com
spoc-ortho.com/about/patient-education/linq-si-joint-stabilization-system-si-joint-dysfunction-patientsSI Joint Stabilization System for SI Joint Dysfunction Patients
Mark Sison now offer PainTEQ's breakthrough LinQ procedure to our patients experiencing SI (sacroiliac) joint dysfunction. ... Proven effective results.
Clinical outcomes for minimally invasive... : Pain Practice
We found no instances of adverse events or post‐operative complications among the patients included. an increase in pain or worsening harm after the ...
7.
painteq.com
painteq.com/clinician/news/painteq-announces-first-patient-enrolled-in-the-traqtion-studyPainTEQ Announces First Patient Enrolled in the TRAQTION Study
The study is designed to evaluate patient-reported outcomes, safety, healthcare utilization, and the real-world experience associated with posterior sacroiliac ...
Minimally Invasive SI Joint Fusion Procedures for Chronic ...
Safety outcomes: Symptomatic implant malposition—typically resulting in new onset acute radicular pain—requiring surgical intervention.
Minimally Invasive Arthrodesis of the Sacroiliac Joint (SIJ)
Numerous studies have reported positive outcomes, including pain relief and improved function for patients with SIJ dysfunction.
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