Last updated: April 19, 2023
Sponsor: Tenon Medical
Overall Status: Active - Enrolling
Phase
N/A
Condition
Ankylosing Spondylitis
Treatment
N/AClinical Study ID
NCT05628142
PTL016
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient >18 years of age at time of treatment with the CATAMARAN SI Joint FusionSystem
- 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 toparticipate in the study
- Patient is willing and able to complete study follow-up requirements
Exclusion
Exclusion Criteria:
- Known or suspected active drug or alcohol abuse
- Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history ofosteoporotic 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-tissuehealing
- 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
Study Design
Total Participants: 50
Study Start date:
November 01, 2022
Estimated Completion Date:
November 30, 2024
Study Description
Connect with a study center
Minimally Invasive Neurosurgery of Texas
Plano, Texas 75024
United StatesSite Not Available
St. George Orthopaedic Spine
Saint George, Utah 84790
United StatesSite Not Available
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