Prospective, Multi-Center, Single Arm Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to evaluate the outcomes of patients with sacroiliac joint pain treated with the CATAMARAN SI Joint Fusion System.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:

‣ Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and

⁃ Patient has at least 3 of 5 physical examination maneuvers specific for SI joint pain (Fabers, Compression, Distraction,Thigh thrust, Gaenslen's test, and/or Sacral thrust test), and

⁃ Patient has improvement in lower back pain VAS of at least 50% of the pre injection VAS after fluoroscopic controlled injection of local anesthetic into affected SI joint(s) (including previous documented test \<6 months ago)

• Patient has failed conservative care (non-surgical) \> 6 months

• Patient has a pre-operative Oswestry Disability Index score \> 30%

• Patient has a pre-operative SI joint pain score of \> 50 on a 0-100 mm visual analog scale (VAS)

• Patient, or authorized representative, signs a written Informed Consent form to participate in the study

• Patient is willing and able to complete study follow-up requirements

Locations
United States
Idaho
Northwest Specialty Hospital
RECRUITING
Coeur D'alene
Indiana
Comprehensive Pain and Spine Specialists
RECRUITING
Muncie
Kentucky
Vitality Pain Centers
RECRUITING
Louisville
Minnesota
Orthopedic Associates of Duluth
RECRUITING
Duluth
Missouri
St. Louis Pain Consultants
RECRUITING
Chesterfield
Utah
St. George Orthopedic Spine
RECRUITING
St. George
Contact Information
Primary
Calvin Lincé
clince@linceconsulting.com
(510)274-7483
Time Frame
Start Date: 2022-11-14
Estimated Completion Date: 2026-01
Participants
Target number of participants: 50
Treatments
Experimental: CATAMARAN SI Joint Fusion System
Placement of the Catamaran Fixation Device
Related Therapeutic Areas
Sponsors
Leads: Tenon Medical

This content was sourced from clinicaltrials.gov