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

NCT05633888 | Recruiting FDA Device

• 1 other identifier: PTL015
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects that meet the definition of Subject Success at 6 months post-procedure

  Change from baseline in VAS SI joint pain score to be reduced by at least 20 mm, Lack of device-related serious adverse events, Absence of neurologic worsening related to the sacral spine compared to baseline (unless attributable to a concurrent medical condition or other cause unrelated to the device and/ or study procedure), and Absence of surgical re-intervention (removal, revision, reoperation, or supplemental fixation) for SI joint pain.

  6 months post procedure

Study Arms (1)

CATAMARAN SI Joint Fusion System

EXPERIMENTAL

Placement of the Catamaran Fixation Device

Device: CATAMARAN SI Joint Fusion System

Interventions

CATAMARAN SI Joint Fusion System DEVICE

Placement of the Catamaran Fixation Device

CATAMARAN SI Joint Fusion System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tenon Medical: lead

Study Sites (6)

Northwest Specialty Hospital

Coeur d'Alene, Idaho, 83815, United States

RECRUITING

Comprehensive Pain and Spine Specialists

Muncie, Indiana, 47304, United States

RECRUITING

Vitality Pain Centers

Louisville, Kentucky, 40241, United States

RECRUITING

Orthopedic Associates of Duluth

Duluth, Minnesota, 55805, United States

RECRUITING

St. Louis Pain Consultants

Chesterfield, Missouri, 63017, United States

RECRUITING

St. George Orthopedic Spine

St. George, Utah, 84790, United States

RECRUITING

Central Study Contacts

Calvin Lincé

CONTACT

(510)274-7483; clince@linceconsulting.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 1, 2022
• Study Start: November 14, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)