NCT05114135

TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)

First-in-man Safety and Performance of OSTEO3 ZP PUTTY in Subjects Undergoing Transforaminal Lumbar Interbody Fusion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: OssDsign · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In recent years there has been an increase in interest from surgeons in the use of synthetic bone graft substitutes to avoid the need of sourcing allograft or iliac crest autograft for use in spinal fusion procedures. This will be an open label, prospective, first in man, single-centre clinical study to evaluate the safety and performance of Osteo3 ZP Putty synthetic bone graft in TLIF procedures with instrumented PLF. Safety and performance data obtained in this clinical study will be used to estimate clinical success rates achieved with the use of Osteo3 ZP Putty synthetic bone graft in TLIF procedures. No comparative control group is intended. The study is expected to run for approximately three years with each subject being followed up for a two- year post-operative period. The target is to recruit approximately 17 subjects to this clinical study, allowing for some subject attrition to get 15 evaluable.

Conditions

• Degenerative Disc Disease
• Degenerative Spondylolisthesis
• Lumbar Spinal Stenosis

Interventions

Type	Name	Description
DEVICE	Osteo3 ZP Putty	Transforminal Interbody Fusion at one spinal level (L2-S1) with instrumented posteriorlateral fusion on at least the contralateral side to the TLIF approach.

Timeline

• Start date: 2021-09-07
• Primary completion: 2023-04-20
• Completion: 2024-03-14
• First posted: 2021-11-09
• Last updated: 2024-07-10

Locations

1 site across 1 country: Hungary