Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

Not Applicable

• Conditions: Degenerative Sacroiliitis; Sacroiliac Joint Disruption
• Interventions: Radiation: Pelvic CT Scan

• Registration Number: NCT05628142
• Lead Sponsor: Tenon Medical

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.

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-21
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CATAMARAN SI Joint Fusion System	Pelvic CT Scan	Subjects previously treated with the CATAMARAN Fixation Device

Primary Outcome Measures

Name	Time	Method
Radiographic Fusion	6-12 month post CATAMARAN Fixation Device implantation	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

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

Trial Locations

Locations (2)

Minimally Invasive Neurosurgery of Texas; 🇺🇸 Plano, Texas, United States

St. George Orthopaedic Spine; 🇺🇸 Saint George, Utah, United States