Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

NCT05628142 | Unknown FDA Device

• 1 other identifier: PTL016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Sacroiliac Joint Disruption; Degenerative Sacroiliitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Device Status

  6-12 months post-op

• Surgical re-intervention for SI joint pain

  6-12 months post-op

• Neurologic worsening related to the sacral spine

  6-12 months post-op

• Serious device related adverse events

  6-12 months post-op

Study Arms (1)

CATAMARAN SI Joint Fusion System

OTHER

Subjects previously treated with the CATAMARAN Fixation Device

Radiation: Pelvic CT Scan

Interventions

Pelvic CT Scan RADIATION

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

CATAMARAN SI Joint Fusion System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tenon Medical: lead

Study Sites (2)

Minimally Invasive Neurosurgery of Texas

Plano, Texas, 75024, United States

Location

St. George Orthopaedic Spine

St. George, Utah, 84790, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)