LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

Part of paid clinical trials in Fort Wayne, Indiana.

Sponsor
Locate Bio Pty Ltd
Study ID
NCT06462729
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • LDGraft — DEVICE
    LDGraft 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
  • LDGraft — DEVICE
    LDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
  • Allograft Bone — OTHER
    Allograft bone (100% human tissue product) applied within intervertebral cage with placement of anterior fixation (plate and screws)

Study Details

The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of patients with lumbar degenerative disc disease (DDD).

Key Dates

Start date
Nov 12, 2024
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: LDGraft 0.5mg/cc
  • Experimental: LDGraft 1.0mg/cc
  • Active Comparator: Control Allograft Bone

Primary Outcome Measure

Radiographic Fusion [ Time Frame: 12 months and 24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Orthopaedics NorthEastFort WayneIndiana46825
Study Coordinator
[email protected]
260-408-2643
Micah Smith, MD (PRINCIPAL_INVESTIGATOR)
Pinehurst Surgical ClinicPinehurstNorth Carolina28374
Nicole Goolsby
Daniel Williams, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fort Wayne, IN

By research site
Orthopaedics NorthEast· Fort Wayne, INPinehurst Surgical Clinic· Pinehurst, NC

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