Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
CGBio Inc.
Study ID
NCT07017634
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Novosis Putty — DEVICE
    Single Level TLIF surgery with Novosis Putty
  • Standard of Care — OTHER
    Single Level TLIF surgery with standard of care bone graft

Study Details

Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients with Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Nov 30, 2031

Study Design

Enrollment
316 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Novosis Putty
  • Active Comparator: Standard of Care

Primary Outcome Measure

Overall Success [ Time Frame: 24 months after surgery ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
The Spine Center of LouisianaBaton RougeLouisiana70809
Ana Heully
[email protected]
225-515-5700
Heather Bowman
Kevin McCarthy (PRINCIPAL_INVESTIGATOR)
LSU HealthShreveportLouisiana71101
Saraith Bernard
[email protected]
281-236-8492
Jessica Paul
Anthony Sin (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University - Department of Neurological SurgeryPhiladelphiaPennsylvania19107
Mary Gomez
[email protected]
215-503-4852
Sha'Mere Herder
Joshua Heller (PRINCIPAL_INVESTIGATOR)
American Neurospine Institute, PLLCFriscoTexas75034
Gladcy Mathew
[email protected]
469-989-3768
Ezioma Akwara
Ripul Panchal (PRINCIPAL_INVESTIGATOR)
West Virginia University - Department of OrthopaedicsMorgantownWest Virginia26506
Jennifer Eicher
[email protected]
304-293-2485
Monica Maxwell
Scott Daffner (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baton Rouge, LA

By research site
The Spine Center of Louisiana· Baton Rouge, LALSU Health· Shreveport, LAThomas Jefferson University - Department of Neurological Surgery· Philadelphia, PAAmerican Neurospine Institute, PLLC· Frisco, TXWest Virginia University - Department of Orthopaedics· Morgantown, WV

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