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

Primary Purpose

Sacroiliac Joint Disruption, Degenerative Sacroiliitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CATAMARAN SI Joint Fusion System
Sponsored by
Tenon Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sacroiliac Joint Disruption

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Northwest Specialty HospitalRecruiting
  • Vitality Pain CentersRecruiting
  • St. Louis Pain ConsultantsRecruiting
  • St. George Orthopedic SpineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CATAMARAN SI Joint Fusion System

Arm Description

Placement of the Catamaran Fixation Device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 14, 2022
Last Updated
July 10, 2023
Sponsor
Tenon Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05633888
Brief Title
Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System
Official Title
Prospective, Multi-Center, Single Arm Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tenon Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Disruption, Degenerative Sacroiliitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CATAMARAN SI Joint Fusion System
Arm Type
Experimental
Arm Description
Placement of the Catamaran Fixation Device
Intervention Type
Device
Intervention Name(s)
CATAMARAN SI Joint Fusion System
Intervention Description
Placement of the Catamaran Fixation Device
Primary Outcome Measure Information:
Title
Proportion of subjects that meet the definition of Subject Success at 6 months post-procedure
Description
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.
Time Frame
6 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Calvin Lincé
Phone
(510)274-7483
Email
clince@linceconsulting.com
Facility Information:
Facility Name
Northwest Specialty Hospital
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Maples
Email
elisa.maples@nwsh.com
Facility Name
Vitality Pain Centers
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Drew Beacham
Email
dbeacham@vitalitypain.com
Facility Name
St. Louis Pain Consultants
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olayinka Idowu
Email
olayinka.idowu@stl-pain.com
Facility Name
St. George Orthopedic Spine
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Stouffer, MD, FAAOS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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