Recruiting

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

Sponsor:

Tenon Medical

Code:

NCT05633888

Conditions

Sacroiliac Joint Disruption

Degenerative Sacroiliitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CATAMARAN SI Joint Fusion System

Study Details

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.

Conditions

Sacroiliac Joint Disruption

Degenerative Sacroiliitis

Study ID

NCT05633888

Start date

Nov 14, 2022

Status verified date

Mar, 2024

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: CATAMARAN SI Joint Fusion System

Placement of the Catamaran Fixation Device

Interventions

CATAMARAN SI Joint Fusion System

Placement of the Catamaran Fixation Device

Primary outcome measure

Proportion of subjects that meet the definition of Subject Success at 6 months post-procedure [ Time Frame: 6 months post procedure ]

Central Contacts and Locations

Central contacts

Calvin Lincé

(510)274-7483 clince@linceconsulting.com

Locations

Northwest Specialty Hospital

Recruiting

Coeur d'Alene, Idaho, United States, 83815

Contacts

Elisa Maples

elisa.maples@nwsh.com

Principal Investigator:

Roland Kent, MD

Comprehensive Pain and Spine Specialists

Recruiting

Muncie, Indiana, United States, 47304

Contacts

Erika Stogsdill

ehuffman@majorhospital.org

Principal Investigator:

Andrew T Trobridge, MD

Vitality Pain Centers

Recruiting

Louisville, Kentucky, United States, 40241

Contacts

Drew Beacham

dbeacham@vitalitypain.com

Principal Investigator:

Timothy J Beacham, MD

Orthopedic Associates of Duluth

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Athena Davies

adavies@twu.edu

Principal Investigator:

Mathew Davies, MD

St. Louis Pain Consultants

Recruiting

Chesterfield, Missouri, United States, 63017

Contacts

Olayinka Idowu

olayinka.idowu@stl-pain.com

Principal Investigator:

Anne Christopher, MD

St. George Orthopedic Spine

Recruiting

Saint George, Utah, United States, 84790

Principal Investigator:

Mark Stouffer, MD, FAAOS

More Information

Sponsor

Tenon Medical

Last update posted

Mar 20, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tenon Medical on 2024-03-20.