CATAMARAN™ SI Joint Fusion System for Sacroiliac Joint Dysfunction

Recruiting at 6 trial locations

Overseen By Calvin Lincé

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Tenon Medical

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the outcomes of patients with sacroiliac joint pain treated with the CATAMARAN SI Joint Fusion System.

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 data supports the idea that CATAMARAN™ SI Joint Fusion System for Sacroiliac Joint Dysfunction is an effective treatment?

The available research shows that minimally invasive sacroiliac joint fusion systems, like the CATAMARAN™ SI Joint Fusion System, can lead to significant improvements in pain and quality of life for patients. Studies on similar systems report positive outcomes, such as reduced pain and decreased reliance on pain medication, within six months to a year after treatment. These results suggest that the CATAMARAN™ system could be an effective option for those suffering from sacroiliac joint dysfunction. ^{1 2 3 4 5}

What safety data is available for the CATAMARAN SI Joint Fusion System?

The available research does not specifically mention the CATAMARAN SI Joint Fusion System by name. However, it provides evidence supporting the long-term safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) for sacroiliac joint dysfunction. Studies highlight the benefits of minimally invasive techniques, such as pain reduction and improved quality of life, and discuss various systems used for SI joint fusion, including the SImmetry SI Joint Fusion System. These studies suggest that minimally invasive SI joint fusion is generally considered safe and effective, although specific data on the CATAMARAN system is not provided. ^{1 3 6 7 8}

Is the CATAMARAN SI Joint Fusion System a promising treatment for sacroiliac joint dysfunction?

Yes, the CATAMARAN SI Joint Fusion System is a promising treatment for sacroiliac joint dysfunction. It offers a minimally invasive approach, which means less pain and quicker recovery for patients. This system aims to provide immediate stability and long-term joint support, improving the quality of life for those with chronic low back pain related to the sacroiliac joint. ^{1 3 9 10 11}

Eligibility Criteria

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

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

Known allergy to titanium or titanium alloys

My diabetes is not under control.

Trial Timeline

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)

Treatment Details

Interventions

• CATAMARAN SI Joint Fusion System (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.

Participant Groups

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

Placement of the Catamaran Fixation Device

Who Is Running the Clinical Trial?

Tenon Medical

Lead Sponsor

Trials

2

Recruited

100+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Minimally invasive arthrodesis for chronic sacroiliac joint dysfunction using the SImmetry SI Joint Fusion system. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical Outcomes Following Minimally Invasive Sacroiliac Joint Fusion With Decortication: The EVoluSIon Clinical Study. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[Minimally invasive arthrodesis of the sacroiliac joint (SIJ)]. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Sacroiliac Joint Fusion Using Robotic Navigation: Technical Note and Case Series. [2023]

5. United Arab Emirates 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. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Long-Term Prospective Clinical And Radiographic Outcomes After Minimally Invasive Lateral Transiliac Sacroiliac Joint Fusion Using Triangular Titanium Implants. [2022]

7. Germany 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. [2023]

8. United States 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. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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

11. Germany pubmed.ncbi.nlm.nih.gov

[Diagnosis of Patients with Painful Sacroiliac Joint Syndrome]. [2019]