Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

Sacroiliac Joint Disruption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05628142
• Other study ID #: PTL016
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: November 2024

Study information

• Verified date: April 2023
• Source: Tenon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Sacroiliitis
• Sacroiliac Joint Disruption
• Sacroiliitis

Intervention

Radiation:
• Pelvic CT Scan
Pelvic CT-Scan between 6-12 months post-op

Locations

Country	Name	City	State
United States	Minimally Invasive Neurosurgery of Texas	Plano	Texas
United States	St. George Orthopaedic Spine	Saint George	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Tenon Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Device Status	Radiographic assessment for device status: device placement, loosening, migration and/or breakage	6-12 months post-op
Secondary	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
Secondary	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
Secondary	Serious device related adverse events	Summary of all serious device related adverse events	6-12 months post-op