CATAMARAN™ SI Joint Fusion System for Sacroiliac Joint Dysfunction

Recruiting at 7 trial locations

Overseen By Calvin Lincé

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tenon Medical

Disqualifiers: Severe lower back pain, Osteoporosis, Obesity, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the CATAMARAN SI Joint Fusion System for individuals with sacroiliac joint pain. The goal is to determine how effectively this treatment reduces pain and improves daily life for those with specific joint issues. It targets individuals who have experienced sacroiliac joint problems for an extended period, have not found relief with other non-surgical treatments, and can clearly identify their pain location. Participants should be able to comply with study requirements and agree to the study terms. As an unphased trial, this study provides a unique opportunity to enhance understanding of this treatment's impact on sacroiliac joint pain.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CATAMARAN SI Joint Fusion System is safe for treating sacroiliac joint dysfunction?

Research has shown that the CATAMARAN SI Joint Fusion System is generally safe for people. In earlier studies, this system significantly reduced pain in those with long-term sacroiliac joint pain. After six months, most patients experienced a notable decrease in pain, and no serious side effects occurred. Another study found that after a year, the system successfully facilitated joint fusion in 83% of cases, indicating its effectiveness for many people. Overall, these findings suggest the treatment is well-tolerated and safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CATAMARAN SI Joint Fusion System is unique because it offers a minimally invasive approach to treating sacroiliac joint dysfunction. Unlike traditional options like physical therapy, pain medications, or more invasive surgeries, this system uses a specially designed Catamaran Fixation Device to stabilize the joint. Researchers are excited because this method could provide quicker recovery times and less postoperative pain, improving overall patient outcomes.

What evidence suggests that the CATAMARAN SI Joint Fusion System is effective for sacroiliac joint dysfunction?

Research has shown that the CATAMARAN SI Joint Fusion System, which participants in this trial will receive, can effectively reduce pain in the sacroiliac joint. One study found that 80% of patients experienced significant pain relief, with their pain level dropping by at least 20 points on a pain scale within six months. Another study reported that 83% of patients achieved successful joint fusion after a year, with pain scores decreasing from 78.8 to 23.0. These findings suggest that the CATAMARAN system can greatly benefit people with sacroiliac joint problems. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with sacroiliac joint pain who have not improved after 6 months of non-surgical care. They must be able to identify their pain spot, show a significant response to local anesthetic injections in the SI joint, and meet specific physical exam criteria. Excluded are those with certain psychiatric diseases, severe back pain from other causes, recent pelvic fractures, metal allergies, active cancer or infections, uncontrolled diabetes, pregnancy plans within two years, or substance abuse.

Inclusion Criteria

Patient, or authorized representative, signs a written Informed Consent form to participate in the study

Patient is willing and able to complete study follow-up requirements

I have been diagnosed with sacroiliac joint problems.

Exclusion Criteria

Known allergy to titanium or titanium alloys

Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation

My diabetes is not under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of the Catamaran Fixation Device for sacroiliac joint fusion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CATAMARAN SI Joint Fusion System

Trial Overview

The study tests the CATAMARAN SI Joint Fusion System on patients with sacroiliitis or degenerative conditions of the sacroiliac joint. It aims to assess if this system effectively reduces pain and improves function post-treatment compared to previous methods.

How Is the Trial Designed?

Group I: CATAMARAN SI Joint Fusion System Experimental Treatment 1 Intervention

Placement of the Catamaran Fixation Device

CATAMARAN SI Joint Fusion System is already approved in United States for the following indications:

Approved in United States as CATAMARAN SI Joint Fusion System for:

• Sacroiliac joint disruptions
• Degenerative sacroiliitis

Who Is Running the Clinical Trial?

Tenon Medical

Lead Sponsor

Trials

2

Recruited

100+

Published Research Related to This Trial

In a study of 26 patients over 4 years, sacroiliac joint (SIJ) fusion significantly reduced low back pain, with average pain scores dropping from 8.4 preoperatively to 4.6 postoperatively.

Patients also experienced improved quality of life and disability scores, with a notable decrease in opioid use from 82% pre-surgery to 39% post-surgery, indicating effective long-term pain management and satisfaction with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Minimally invasive arthrodesis of the sacroiliac joint (SIJ)]. Kasapovic, A., Ali, T., Jaenisch, M., et al.[2022]

In a study involving 172 patients with sacroiliac joint dysfunction, minimally invasive fusion using triangular titanium implants resulted in significant long-term pain reduction, with SIJ pain decreasing from an average of 79.8 to 26.0 on a visual analog scale over 24 months.

Quality of life improvements were sustained over the two-year period, and the percentage of patients using opioids for pain decreased from 76.2% to 55.0%, indicating both efficacy and a potential reduction in reliance on pain medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial. Duhon, BS., Bitan, F., Lockstadt, H., et al.[2022]

The SImmetry(®) SI Joint Fusion System offers a minimally invasive surgical option for patients with chronic sacroiliac joint-related low back pain who have not responded to conservative treatments, providing immediate stability and long-term joint fusion through instrumented fixation and bone grafting.

This novel therapy addresses the challenges of accurately diagnosing and treating SI joint-related pain, making it a viable option for patients suffering from debilitating pain for at least 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive arthrodesis for chronic sacroiliac joint dysfunction using the SImmetry SI Joint Fusion system. Miller, LE., Block, JE.[2022]

In a study of 118 patients undergoing minimally invasive sacroiliac joint (SIJ) fusion, 94.9% achieved successful fusion as confirmed by CT scans, indicating a high efficacy of the navigated decortication and direct arthrodesis technique.

Patients reported significant improvements in disability and back pain scores at both 6 and 12 months post-surgery, demonstrating the procedure's effectiveness in enhancing quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fusion and patient-reported outcomes after navigated decortication and direct arthrodesis in minimally invasive sacroiliac joint fusion using cylindrical threaded implants: a case series and literature review. Anton, G., Alsalahi, A., Yoon, EJ., et al.[2023]

A study involving 10 patients showed that robotic navigation for sacroiliac joint fusion resulted in no complications, a short operative time of about 54 minutes, and minimal blood loss, indicating a safe and efficient surgical method.

Patients experienced an average of 73.1% improvement in pain levels after surgery, with most being discharged on the same day, highlighting the efficacy of this minimally invasive approach for treating refractory SI joint disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacroiliac Joint Fusion Using Robotic Navigation: Technical Note and Case Series. Wang, TY., Bergin, SM., Murphy, KR., et al.[2023]

Sacroiliac (SI) joint pain can account for up to 25% of chronic low back pain, making accurate diagnosis crucial, particularly through physical examination and local anaesthetic injections to confirm pain relief.

Minimally invasive SI joint fusion, especially using the iFuse Implant System®, is more effective than traditional open surgery, offering benefits like reduced blood loss, shorter recovery times, and improved joint stabilization due to its unique design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnosis of Patients with Painful Sacroiliac Joint Syndrome]. Bornemann, R., Pflugmacher, R., Koch, EMW., et al.[2019]

Primary sacroiliac joint fusion (SIJF) significantly reduces low back pain and disability in patients with sacroiliac joint pathology compared to conservative management, with notable improvements observed at both three and six months follow-up.

Despite showing potential benefits, the overall quality of evidence for SIJF is low, and there is a higher risk of adverse reactions compared to conservative management, indicating the need for further independent studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of primary sacroiliac joint fusion for low back pain caused by sacroiliac joint pathology: a systematic review and meta-analysis. Abbas, A., Du, JT., Toor, J., et al.[2023]

Minimally invasive (MI) revision surgery for symptomatic nonunions after sacroiliac joint (SIJ) fusion can effectively resolve pain, as demonstrated in four patients who underwent successful revision with a new implant system and achieved symptom resolution within six to twelve months.

The study highlights the importance of implant trajectory in achieving successful bony fusion, suggesting that a more ventral-to-dorsal and caudal-to-cranial approach may enhance the effectiveness of both primary and revision SIJ fusion procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revision of Minimally Invasive Sacroiliac Joint Fixation: Technical Considerations and Case Studies Using Decortication and Threaded Implant Fixation. MenMuir, B., Fielding, LC.[2022]

In a study of 103 patients followed for 5 years after minimally invasive sacroiliac joint fusion (SIJF) using triangular titanium implants, there was a significant reduction in pain and disability, with pain scores decreasing by an average of 54 points and disability scores by 26 points.

Radiographic analysis showed a high success rate of joint fusion (88%) and excellent bone integration with the implants, indicating that SIJF is both effective and safe for treating sacroiliac joint dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Prospective Clinical And Radiographic Outcomes After Minimally Invasive Lateral Transiliac Sacroiliac Joint Fusion Using Triangular Titanium Implants. Whang, PG., Darr, E., Meyer, SC., et al.[2022]

In a study of 50 patients undergoing minimally invasive sacroiliac joint fusion, significant pain reduction was observed, with average Visual Analog Scale (VAS) scores dropping from 76.2 to 35.1, representing a 54% decrease after 6 months.

The procedure also led to a 55% reduction in opioid use among patients, decreasing from 66% pre-surgery to 30% at the 6-month follow-up, indicating both safety and efficacy in managing pain and disability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain and Opioid use Outcomes Following Minimally Invasive Sacroiliac Joint Fusion with Decortication and Bone Grafting: The Evolusion Clinical Trial. Araghi, A., Woodruff, R., Colle, K., et al.[2022]

In a study of 250 patients undergoing minimally invasive sacroiliac joint fusion (SIJF), significant pain reduction was observed, with average pain scores dropping from 76.4 to 33.0 on the Visual Analog Scale after one year, and 72.2% of patients achieving a clinically meaningful improvement.

The procedure also led to a 57.1% decrease in opioid use among patients, from 62.7% pre-surgery to 26.9% post-surgery, highlighting its potential to improve quality of life while addressing concerns related to opioid dependency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes Following Minimally Invasive Sacroiliac Joint Fusion With Decortication: The EVoluSIon Clinical Study. Kucharzyk, D., Colle, K., Boone, C., et al.[2022]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39161110/

Catamaran SI Joint Fusion System(R) MAINSAILTM Study

Methods: The primary endpoint of success at 6 months was defined as a ≥20 mm improvement in SIJ pain (Visual Analog Scale, VAS), no neurologic worsening, ...

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tandfonline.com

tandfonline.com/doi/full/10.1080/17434440.2024.2394168

Catamaran SI Joint Fusion System(R) MAINSAILTM Study

Two-year outcomes from a randomized controlled trial of minimally invasive sacroiliac joint fusion vs. Non-surgical management for sacroiliac joint dysfunction.

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tenonmed.com

tenonmed.com/

Tenon Medical: Catamaran | SI Joint Fusion System

At 6 months, 80% of patients met the criteria for success, defined as a ≥ 20mm reduction in SIJ pain, no serious device-related adverse events, no neurological ...

4.

ryortho.com

ryortho.com/2024/10/interm-data-from-catamaran-si-fusion-study-released/

Interm Data From Catamaran SI Fusion Study Released

The research team reported statistically significant reduction in sacroiliac joint pain and disability scores at six months, with no serious ...

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stocktitan.net

stocktitan.net/news/TNON/tenon-r-medical-announces-second-peer-reviewed-catamaran-mainsail-tm-ymckew42q3sa.html

Tenon Medical: SI Joint Fusion Study Shows 83% Success ...

Clinical study shows Tenon's Catamaran SI Joint system achieved 83% fusion rate and 78.8mm to 23.0mm pain reduction at 12 months.