Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

Prospective, Multi-Center, Single Arm Post-Market Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Sacroiliac Joint Disruption; Degenerative Sacroiliitis
• Intervention / Treatment: Radiation: Pelvic CT Scan

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75024
      • Minimally Invasive Neurosurgery of Texas
  • Utah
    • Saint George, Utah, United States, 84790
      • St. George Orthopaedic Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CATAMARAN SI Joint Fusion System; Subjects previously treated with the CATAMARAN Fixation Device	Radiation: Pelvic CT Scan; Pelvic CT-Scan between 6-12 months post-op

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Fusion	The primary endpoint is the proportion of subjects that demonstrate radiographic fusion assessed by CT-Scan, as evaluated by an Independent Radiologist.	6-12 month post CATAMARAN Fixation Device implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Status	Radiographic assessment for device status: device placement, loosening, migration and/or breakage	6-12 months post-op
Surgical re-intervention for SI joint pain	Proportion of patients requiring surgical re-intervention (removal, revision, reoperation, or supplemental fixation) for SI joint pain	6-12 months post-op
Neurologic worsening related to the sacral spine	Proportion of patients experiencing neurologic worsening related to the sacral spine compared to baseline	6-12 months post-op
Serious device related adverse events	Summary of all serious device related adverse events	6-12 months post-op

Collaborators and Investigators

• Sponsor: Tenon Medical

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Sacroiliitis
• Other Study ID Numbers: PTL016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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