An interventional study of Pelvic CT Scan in Sacroiliac Joint Disruption and Degenerative Sacroiliitis, sponsored by Tenon Medical. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by Tenon Medical · Not applicable, Interventional, and Other
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.
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.
42 studies on the registry are indexed under Sacroiliitis; 11 are open to participants now.
This study's planned enrollment of 50 is close to the median of 48 across 28 interventional studies indexed under Sacroiliitis.
Browse Sacroiliitis studies →Tenon Medical is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects previously treated with the CATAMARAN Fixation Device
Radiation: Pelvic CT Scan
Pelvic CT-Scan between 6-12 months post-op
Radiographic Fusion
The primary endpoint is the proportion of subjects that demonstrate radiographic fusion assessed by CT-Scan, as evaluated by an Independent Radiologist.
Time frame: 6-12 month post CATAMARAN Fixation Device implantation
Device Status
Radiographic assessment for device status: device placement, loosening, migration and/or breakage
Time frame: 6-12 months post-op
Surgical re-intervention for SI joint pain
Proportion of patients requiring surgical re-intervention (removal, revision, reoperation, or supplemental fixation) for SI joint pain
Time frame: 6-12 months post-op
Neurologic worsening related to the sacral spine
Proportion of patients experiencing neurologic worsening related to the sacral spine compared to baseline
Time frame: 6-12 months post-op
Serious device related adverse events
Summary of all serious device related adverse events
Time frame: 6-12 months post-op
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Nov 2024, 24 months after the start.
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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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