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Procedure
SI Joint Fusion for Sacroiliac Joint Dysfunction
N/A
Waitlist Available
Research Sponsored by Tenon Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 months post-op
Awards & highlights
Study Summary
This trial studies how well a new SI Joint Fusion System works for patients with sacroiliac joint issues after 6-12 months of treatment. Clinical outcomes will also be reviewed.
Who is the study for?
This trial is for adults over 18 who've had the CATAMARAN SI Joint Fusion System implanted in the last year to treat sacroiliac joint disruptions or degenerative sacroiliitis. Participants must consent to follow-up and not have severe osteoporosis, metabolic bone diseases, be pregnant, or have a history of substance abuse.Check my eligibility
What is being tested?
The study aims to assess radiographic outcomes using pelvic CT scans from patients treated with the CATAMARAN system for sacroiliac joint issues. It will also retrospectively and prospectively evaluate clinical results at 6-to-12 months post-treatment.See study design
What are the potential side effects?
While this study focuses on imaging rather than drug side effects, potential risks may include exposure to radiation from CT scans which is associated with a very small increased risk of cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-12 months post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 months post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic Fusion
Secondary outcome measures
Device Status
Neurologic worsening related to the sacral spine
Serious device related adverse events
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CATAMARAN SI Joint Fusion SystemExperimental Treatment1 Intervention
Subjects previously treated with the CATAMARAN Fixation Device
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Who is running the clinical trial?
Tenon MedicalLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Degenerative Sacroiliitis
50 Patients Enrolled for Degenerative Sacroiliitis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a bone break due to my cancer.I am willing and able to follow the study's requirements.I am over 18 years old and will be treated with the CATAMARAN SI Joint Fusion System.I am not taking medications that harm bone or tissue healing.I am pregnant or plan to become pregnant during the study.I was previously diagnosed with a tumor in my sacrum or ilium.I have an unstable fracture in my lower back affecting the sacrum or ilium.I have been diagnosed with osteoporosis or have taken medication for it.I have a bone condition like osteomalacia.I have been diagnosed with sacroiliac joint problems.
Research Study Groups:
This trial has the following groups:- Group 1: CATAMARAN SI Joint Fusion System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for volunteers at this clinical trial?
"According to the information available on clinicaltrials.gov, this specific medical trial is not presently recruiting participants—it was initially posted on November 1st 2022 and last updated 16 days later. However, there are currently 5 other studies looking for patients right now."
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