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NCT05633888 | RECRUITING | Sacroiliac Joint Disruption

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

Tenon Medical

Brief Summary:

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

Condition or disease

Sacroiliac Joint Disruption

Degenerative Sacroiliitis

Intervention/treatment

CATAMARAN SI Joint Fusion System

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Prospective, Multi-Center, Single Arm Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System
Actual Study Start Date : 2022-11-14
Estimated Primary Completion Date : 2025-01
Estimated Study Completion Date : 2026-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System

Location Details

NCT05633888

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Idaho

Northwest Specialty Hospital

Coeur d'Alene, Idaho, United States, 83815

RECRUITING

United States, Indiana

Comprehensive Pain and Spine Specialists

Muncie, Indiana, United States, 47304

RECRUITING

United States, Kentucky

Vitality Pain Centers

Louisville, Kentucky, United States, 40241

RECRUITING

United States, Minnesota

Orthopedic Associates of Duluth

Duluth, Minnesota, United States, 55805

RECRUITING

United States, Missouri

St. Louis Pain Consultants

Chesterfield, Missouri, United States, 63017

RECRUITING

United States, Utah

St. George Orthopedic Spine

Saint George, Utah, United States, 84790