Evaluating the CATAMARAN SI Joint Fusion System for sacroiliac joint pain

Prospective, Multi-Center, Single Arm Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System

This study tests if the CATAMARAN SI Joint Fusion System can help people with sacroiliac joint pain feel better and improve their daily activities.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tenon Medical (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 6 sites (Coeur d'Alene, Idaho and 5 other locations)
• Trial ID: NCT05633888 on ClinicalTrials.gov

What this trial studies

This study assesses the clinical outcomes of patients suffering from sacroiliac joint disruptions or degenerative sacroiliitis who are treated with the CATAMARAN SI Joint Fusion System. It is a multi-center post-market feasibility study that aims to gather data on the effectiveness of this intervention in alleviating pain and improving function. Patients will be evaluated based on specific diagnostic criteria and their responses to treatment will be monitored over time.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with sacroiliac joint disruption or degenerative sacroiliitis who have not found relief from conservative treatments for over six months.

Not a fit: Patients who have not been diagnosed with sacroiliac joint issues or those who have not failed conservative care may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce pain and improve quality of life for patients with sacroiliac joint issues.

How similar studies have performed: Other studies have shown promise in treating sacroiliac joint pain with surgical interventions, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:

  * Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and
  * Patient has at least 3 of 5 physical examination maneuvers specific for SI joint pain (Fabers, Compression, Distraction,Thigh thrust, Gaenslen's test, and/or Sacral thrust test), and
  * Patient has improvement in lower back pain VAS of at least 50% of the pre injection VAS after fluoroscopic controlled injection of local anesthetic into affected SI joint(s) (including previous documented test \<6 months ago)
* Patient has failed conservative care (non-surgical) \> 6 months
* Patient has a pre-operative Oswestry Disability Index score \> 30%
* Patient has a pre-operative SI joint pain score of \> 50 on a 0-100 mm visual analog scale (VAS)
* 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

Exclusion Criteria:

* Planned bi-lateral SI joint fixation
* Severe lower back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture (this is done by physical exam, medical history, and MRI/CT/X-ray as required)
* Other known sacroiliac pathology such as: sacral dysplasia, inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA- associated spondyloarthropathy), tumor, acute fracture, crystal arthropathy
* History of recent (\<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring
* Severe osteoporosis
* Paget's disease, osteomalacia, osteomalacia or other metabolic bone disease
* Any condition or anatomy that makes treatment with the CATAMARAN SI Joint Fusion System infeasible including deformity
* Known allergy to titanium or titanium alloys
* Morbid obesity
* Active malignancy: a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least five years
* Patient has systemic infection or active infection at the treatment site
* Chronic rheumatologic condition (e.g., rheumatoid arthritis)
* Patient has uncontrolled diabetes
* Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation
* Prominent neurologic condition that would interfere with physical therapy
* Patient is pregnant or wishes to become pregnant in the next two years
* Patient is not likely to comply with the follow-up evaluation schedule
* Patient is participating in a clinical trial of another investigational drug or device in which the primary endpoint has not occurred
* Patient has a psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
* Known or suspected drug or alcohol abuse
* Patient is a prisoner or a ward of the state

Where this trial is running

Coeur d'Alene, Idaho and 5 other locations

• Northwest Specialty Hospital — Coeur d'Alene, Idaho, United States (Recruiting)
• Comprehensive Pain and Spine Specialists — Muncie, Indiana, United States (Recruiting)
• Vitality Pain Centers — Louisville, Kentucky, United States (Recruiting)
• Orthopedic Associates of Duluth — Duluth, Minnesota, United States (Recruiting)
• St. Louis Pain Consultants — Chesterfield, Missouri, United States (Recruiting)
• St. George Orthopedic Spine — Saint George, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Calvin Lincé

Conditions Sacroiliac Joint Disruption; Degenerative Sacroiliitis