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Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

Primary Purpose

Sacroiliac Joint Disruption, Degenerative Sacroiliitis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic CT Scan
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient >18 years of age at time of treatment with the CATAMARAN SI Joint Fusion System Patient implanted with the CATAMARAN Fixation Device within the last 12 months Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis 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: Known or suspected active drug or alcohol abuse Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture) or prior/current use of drug therapy for osteoporosis. Prior fracture of any bone related to cancer/tumor (i.e., pathologic fracture) Prior diagnosis of tumor in sacrum or ilium Unstable fracture of sacrum and or ilium involving the targeted SIJ Osteomalacia or other metabolic bone disease Use of medications known to have detrimental effects on bone quality and soft-tissue healing Patient is pregnant or wishes to become pregnant during the study period Patient is not likely to comply with the follow-up evaluation schedule Patient is a prisoner or a ward of the state

Sites / Locations

  • Minimally Invasive Neurosurgery of Texas
  • St. George Orthopaedic Spine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CATAMARAN SI Joint Fusion System

Arm Description

Subjects previously treated with the CATAMARAN Fixation Device

Outcomes

Primary Outcome Measures

Radiographic Fusion
The primary endpoint is the proportion of subjects that demonstrate radiographic fusion assessed by CT-Scan, as evaluated by an Independent Radiologist.

Secondary Outcome Measures

Device Status
Radiographic assessment for device status: device placement, loosening, migration and/or breakage
Surgical re-intervention for SI joint pain
Proportion of patients requiring surgical re-intervention (removal, revision, reoperation, or supplemental fixation) for SI joint pain
Neurologic worsening related to the sacral spine
Proportion of patients experiencing neurologic worsening related to the sacral spine compared to baseline
Serious device related adverse events
Summary of all serious device related adverse events

Full Information

First Posted
November 16, 2022
Last Updated
April 19, 2023
Sponsor
Tenon Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05628142
Brief Title
Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study
Official Title
Prospective, Multi-Center, Single Arm Post-Market Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (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

5. Study Description

Brief Summary
The objective of this study is to evaluate 6-to-12-month radiographic outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis that have already undergone treatment with the CATAMARAN SI Joint Fusion System. In addition, retrospective and prospective clinical outcomes will be evaluated.
Detailed Description
Patients with degenerative sacroiliitis or sacroiliac joint disruption who already had the CATAMARAN Fixation Device implanted between 6 and 12 months will be asked to return for follow-up visit to evaluate clinical outcomes and undergo a high resolution pelvic CT-Scan to assess fusion. Additionally, retrospective clinical outcomes will be collected from the medical records.

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
Other
Arm Description
Subjects previously treated with the CATAMARAN Fixation Device
Intervention Type
Radiation
Intervention Name(s)
Pelvic CT Scan
Intervention Description
Pelvic CT-Scan between 6-12 months post-op
Primary Outcome Measure Information:
Title
Radiographic Fusion
Description
The primary endpoint is the proportion of subjects that demonstrate radiographic fusion assessed by CT-Scan, as evaluated by an Independent Radiologist.
Time Frame
6-12 month post CATAMARAN Fixation Device implantation
Secondary Outcome Measure Information:
Title
Device Status
Description
Radiographic assessment for device status: device placement, loosening, migration and/or breakage
Time Frame
6-12 months post-op
Title
Surgical re-intervention for SI joint pain
Description
Proportion of patients requiring surgical re-intervention (removal, revision, reoperation, or supplemental fixation) for SI joint pain
Time Frame
6-12 months post-op
Title
Neurologic worsening related to the sacral spine
Description
Proportion of patients experiencing neurologic worsening related to the sacral spine compared to baseline
Time Frame
6-12 months post-op
Title
Serious device related adverse events
Description
Summary of all serious device related adverse events
Time Frame
6-12 months post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient >18 years of age at time of treatment with the CATAMARAN SI Joint Fusion System Patient implanted with the CATAMARAN Fixation Device within the last 12 months Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis 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: Known or suspected active drug or alcohol abuse Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture) or prior/current use of drug therapy for osteoporosis. Prior fracture of any bone related to cancer/tumor (i.e., pathologic fracture) Prior diagnosis of tumor in sacrum or ilium Unstable fracture of sacrum and or ilium involving the targeted SIJ Osteomalacia or other metabolic bone disease Use of medications known to have detrimental effects on bone quality and soft-tissue healing Patient is pregnant or wishes to become pregnant during the study period Patient is not likely to comply with the follow-up evaluation schedule Patient is a prisoner or a ward of the state
Facility Information:
Facility Name
Minimally Invasive Neurosurgery of Texas
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
St. George Orthopaedic Spine
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

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