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Enrolling By Invitation
NCT05628142
Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study
Conditions: Sacroiliac Joint Disruption, Degenerative Sacroiliitis
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 50
Sponsor: Tenon Medical
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Patient >18 years of age at time of treatment with the CATAMARAN SI Joint Fusion SystemPatient implanted with the CATAMARAN Fixation Device within the last 12 monthsDiagnosis of sacroiliac joint disruption or degenerative sacroiliitisPatient, or authorized representative, signs a written Informed Consent form to participate in the studyPatient is willing and able to complete study follow-up requirementsExclusion Criteria:Known or suspected active drug or alcohol abusePreviously 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 iliumUnstable fracture of sacrum and or ilium involving the targeted SIJOsteomalacia or other metabolic bone diseaseUse of medications known to have detrimental effects on bone quality and soft-tissue healingPatient is pregnant or wishes to become pregnant during the study periodPatient is not likely to comply with the follow-up evaluation schedulePatient is a prisoner or a ward of the state
Source: ClinicalTrials.gov (NCT05628142). StuddyBuddy aggregates publicly available trial information.