Clinical Trials Logo

Clinical Trial Summary

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).


Clinical Trial Description

This is a prospective, randomized, controlled, single-blind, dose-finding, multi-center study which intends to demonstrate the safety of both LDGraft groups versus allograft during a single level ALIF procedure. This is a first in human (FIH) study. The study will enroll patients with lumbar degenerative disc disease (DDD) requiring single level ALIF. The procedure will involve use of an intervertebral cage and fixation (plate and screws). Upon successful completion of the Screening period and confirmation of eligibility the participant will allocated 3:3:2 to the LDGraft groups (investigational) or the allograft control group. Participants will be blinded to the treatment assigned however the surgical procedure and the post operative recovery will be managed in accordance with standard clinical practice for anterior lumbar interbody fusion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06462729
Study type Interventional
Source Locate Bio Ltd
Contact Robyn Cochrane
Phone +44 (0)115 784 0041
Email rcochrane@locatebio.com
Status Recruiting
Phase Phase 1/Phase 2
Start date June 2024
Completion date July 2027

See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Active, not recruiting NCT05114135 - TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study) N/A
Suspended NCT04735185 - Stem Cells vs. Steroids for Discogenic Back Pain N/A
Withdrawn NCT03223701 - Efficacy of Using Solum IV and BMC With GFC in TLIF Phase 4
Completed NCT04057235 - Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
Not yet recruiting NCT06000319 - Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Active, not recruiting NCT02969616 - Trinity Elite in Lumbar Fusion
Completed NCT02558621 - New Robotic Assistance System for Spinal Fusion Surgery N/A
Completed NCT02104167 - Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
Terminated NCT00974623 - Bone Graft Materials Observational Registry N/A
Completed NCT00965380 - Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
Completed NCT00996073 - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion Phase 2
Completed NCT00758719 - Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
Completed NCT00165893 - Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease Phase 4
Terminated NCT01494493 - Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease N/A
Recruiting NCT04727385 - Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease N/A
Completed NCT04849429 - Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back Pain Phase 1
Recruiting NCT04469387 - Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion N/A
Recruiting NCT04056520 - Clinical and Radiological Outcomes of Posterior Cervical Fusion With Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
Completed NCT04119466 - Stabilizing Training in Degenerative Disc Disease N/A