NCT06415110

A Prospective Analysis of the Efficacy of Allosync Expand and Autograft Bone Graft in Open Lumbar Spinal Fusion

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Research Source · Network
• Sex: All
• Age: 22 Years
• Healthy volunteers: —

Summary

The purpose of this study is to assess the radiographic and clinical outcomes of spinal fusion following use of Allosync Expand and autograft bone graft.

Detailed description

This is a single site, prospective study with patients selected as study subjects from the Investigator's standard patient population who fulfill the Inclusion/Exclusion Criteria and agree to participate in the study. The study surgery is standard of care, with patients identified as requiring surgery prior to enrollment. The study surgery is lumbar posterior fixation with supplemental posterolateral fusion at from 1 to 3 levels. One side of the posterolateral fusion will be Allosync Expand (utilizing the BMA Angel kit to hydrate) and the other side to autograft bone (control).

Conditions

• Spondylolisthesis, Grade 1

Interventions

Type	Name	Description
DEVICE	Allosync Expand	Allosync Expand is used in lumbar posterolateral arthrodesis at 1-3 contiguous levels (L1-S1)

Timeline

• Start date: 2024-06-05
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2024-05-16
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study