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SI Joint Fusion System

CATAMARAN™ SI Joint Fusion System for Sacroiliac Joint Dysfunction

N/A
Recruiting
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 months post procedure
Awards & highlights

Study Summary

This trial looks at how well a device helps people with SI joint pain, to see if it improves symptoms.

Who is the study for?
This trial is for individuals with sacroiliac joint pain who have not improved after 6 months of non-surgical care. They must be able to identify their pain spot, show a significant response to local anesthetic injections in the SI joint, and meet specific physical exam criteria. Excluded are those with certain psychiatric diseases, severe back pain from other causes, recent pelvic fractures, metal allergies, active cancer or infections, uncontrolled diabetes, pregnancy plans within two years, or substance abuse.Check my eligibility
What is being tested?
The study tests the CATAMARAN SI Joint Fusion System on patients with sacroiliitis or degenerative conditions of the sacroiliac joint. It aims to assess if this system effectively reduces pain and improves function post-treatment compared to previous methods.See study design
What are the potential side effects?
While specific side effects are not listed here for the CATAMARAN system itself as it's a surgical device rather than a drug intervention; generally such procedures may include risks like infection at the surgery site, bleeding complications or allergic reactions to materials used.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects that meet the definition of Subject Success at 6 months post-procedure

Trial Design

1Treatment groups
Experimental Treatment
Group I: CATAMARAN SI Joint Fusion SystemExperimental Treatment1 Intervention
Placement of the Catamaran Fixation Device

Find a Location

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

Media Library

CATAMARAN SI Joint Fusion System (SI Joint Fusion System) Clinical Trial Eligibility Overview. Trial Name: NCT05633888 — N/A
Degenerative Sacroiliitis Research Study Groups: CATAMARAN SI Joint Fusion System
Degenerative Sacroiliitis Clinical Trial 2023: CATAMARAN SI Joint Fusion System Highlights & Side Effects. Trial Name: NCT05633888 — N/A
CATAMARAN SI Joint Fusion System (SI Joint Fusion System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633888 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently open to participants?

"Per the clinicaltrials.gov website, this healthcare study is actively enrolling participants at present. The medical trial was initially advertised on November 1st 2022 and most recently modified on November 21st of that same year."

Answered by AI

Does this clinical research project accept minors as participants?

"This medical trial is targeting adult patients, aged 18 or over and 75 years old or younger."

Answered by AI

Would I fulfill the requirements for participating in this research?

"This clinical trial is looking for up to 50 people aged 18-75 who have been diagnosed with degenerative sacroiliitis. In order to qualify, participants must demonstrate pain around the posterior superior iliac spine (PSIS) that can be pinpointed using the Fortin Finger Test; report a pre-operative SI joint pain score of >50 on a 0-100 mm visual analog scale (VAS); display at least 3/5 physical examination maneuvers specific for SI joint pain; show an improvement in lower back VAS of at least 50% after fluoroscopic injection into affected SI joints where applicable; display failure of non-"

Answered by AI

What is the aggregate size of this clinical experiment?

"Affirmative. According to the clinicaltrials.gov listing, this trial is still recruiting participants as of November 21st 2022 since its initial posting on November 1st 2022. The medical research requires 50 subjects from a single site."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
St. George Orthopedic Spine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System
2022. "Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05633888.
~16 spots leftby Jan 2025
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