Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

NCT ID: NCT05628142

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-11-30

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.

Conditions

Sacroiliac Joint Disruption; Degenerative Sacroiliitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CATAMARAN SI Joint Fusion System

Subjects previously treated with the CATAMARAN Fixation Device

Group Type: OTHER

Pelvic CT Scan

Intervention Type: RADIATION

Pelvic CT-Scan between 6-12 months post-op

Interventions

Pelvic CT Scan

Pelvic CT-Scan between 6-12 months post-op

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tenon Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Minimally Invasive Neurosurgery of Texas

Plano, Texas, United States

St. George Orthopaedic Spine

St. George, Utah, United States

Countries

United States

Other Identifiers

PTL016

Identifier Type: -

Identifier Source: org_study_id