NCT05628142

Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Tenon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
RADIATION	Pelvic CT Scan	Pelvic CT-Scan between 6-12 months post-op

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2022-11-28
• Last updated: 2023-04-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study