Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

Tenon Medical

Status: Invitation-only

Conditions: Degenerative Sacroiliitis; Sacroiliac Joint Disruption

Treatments: Radiation: Pelvic CT Scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT05628142

PTL016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

CATAMARAN SI Joint Fusion System

Other group

Description:

Subjects previously treated with the CATAMARAN Fixation Device

Treatment:

Radiation: Pelvic CT Scan