Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System

Tenon Medical

Status

Enrolling

Conditions

Degenerative Sacroiliitis

Sacroiliac Joint Disruption

Treatments

Device: CATAMARAN SI Joint Fusion System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05633888

PTL015

Details and patient eligibility

About

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

Full description

This is a multi-center post-market study to evaluate the clinical outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis treated with the CATAMARAN SI Joint Fusion System.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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