Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

Status unconfirmed · Not applicable

Conditions studied: Sacroiliac Joint Disruption, Degenerative Sacroiliitis

In brief

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.

Key facts

Study ID

NCT05628142

Run by

Tenon Medical

People needed

50

Starts

2022-11-01

Expected to finish

2024-11-01

Last updated by the study team

2023-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Minimally Invasive Neurosurgery of Texas — Plano, Texas, United States
• St. George Orthopaedic Spine — St. George, Utah, United States

Full record on ClinicalTrials.gov

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