๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-24

LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) (NCT06462729)

A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

๐ŸŸข Recruiting Phase1 / Phase2 โš™๏ธ Medical Device Protocol Sponsor: Locate Bio Pty Ltd

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Orthopaedics NorthEast โ€” Fort Wayne, Indiana

Age range: 22 Years to 80 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (4 Sites)

  • Orthopaedics NorthEast โ€” Fort Wayne, Indiana
  • Pinehurst Surgical Clinic โ€” Pinehurst, North Carolina
  • Tennessee Orthopaedic Alliance โ€” Nashville, Tennessee
  • Newcastle Private Hospital โ€” Newcastle, New South Wales

๐Ÿ“ž Contact the Study Coordinator

Phone: +44 (0)115 784 0041

Email: rcochrane@locatebio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—