Post-Market Clinical Study on a Modular SI Joint Fusion System

Part of paid clinical trials in Port Jefferson Station, New York.

Sponsor
CornerLoc
Study ID
NCT05916092
Status
Enrolling By Invitation

Conditions

  • Sacroiliac Joint Dysfunction
  • Sacroiliitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • TransLoc 3D — DEVICE
    TransLoc 3D SI Joint Fusion System

Study Details

A prospective study on the use of the TransLoc 3D SI Joint Fusion System for patients with sacroiliac joint disruptions or degenerative sacroiliitis.

Key Dates

Start date
Oct 19, 2023
Status verified
Feb 2024
Primary completion
Dec 31, 2025
Completion
Jul 31, 2026

Study Design

Enrollment
240 participants (estimated)

Arms

  • Arm: Lateral-Oblique TransLoc 3D Screw(s)
    Patients receiving the TransLoc 3D Screw(s) version will receive screw(s) placed lateral-obliquely into the intended SI joint.
  • Arm: Lateral Oblique TransLoc 3D Screw with Posterior Device (Hybrid)
    Patients receiving the TransLoc 3D Hybrid construct will receive one 3D-printed titanium screw placed lateral-obliquely and one 3D-printed titanium posterior device across the same sacroiliac joint.

Primary Outcome Measure

Clinical improvement at 12 months defined by a composite score of functional status, pain, and safety events. [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
NY Spine and Pain SpecialistsPort Jefferson StationNew York11776-

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NY Spine and Pain Specialists· Port Jefferson Station, NY

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