OsteoFlo HydroFiber Ambispective Evaluation

Part of paid clinical trials in Naperville, Illinois.

Sponsor
SurGenTec LLC
Study ID
NCT07784673
Status
Enrolling By Invitation

Conditions

  • OsteoFlo HydroFiber

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OsteoFlo HydroFiber — DEVICE
    Observational study of subjects previously implanted with OsteoFlo HydroFiber.

Study Details

The goal of this observational, ambispective study is to collect real world patient outcomes to characterize the safety and effectiveness of OsteoFlo HydroFiber when used to promote fusion in the lumbar spine.

Key Dates

First listed
Aug 25, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Lumbar
    Previously implanted with the OsteoFlo HydroFiber in one or two contiguous vertebral levels of the lumbar spine (L1-S1).

Primary Outcome Measure

Rate of Qualitative Fusion [ Time Frame: 6 months post-op ]

Locations (2)

FacilityCityStateZIPSite coordinators
Duly Health and CareNapervilleIllinois60540-
Orthopaedics NortheastFort WayneIndiana46825-

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Duly Health and Care· Naperville, ILOrthopaedics Northeast· Fort Wayne, IN