NCT05323448

Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Polyclinique Bordeaux Nord Aquitaine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the efficacy of the ARISTA AH for restoring hemostasis following a long segment posterior spinal fusion.

Detailed description

After being informed about the study and potential risks, all patients giving written inform consent will be included in the study during their preoperative visit. After eligibility criteria checking and based on their respective surgical indication, participants will be randomized in a single-blinded and stratified manner (participant only) in a 1:1 ratio to ARISTA-AH or no ARISTA-AH. The stratification process will consider the number of instrumented vertebra during each surgery (level 1: 5 to 8 vertebra; level 2: 9 or more instrumented vertebra).

Conditions

• Hemostatics
• Hemostasis
• Spinal Deformity
• Spinal Fusion

Interventions

Type	Name	Description
DEVICE	Control Group	During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent).
DEVICE	ARISTA	During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent). Before surgical wound closure, the corresponding amount of ARISTA-AH will be applied to completely cover the bleeding site : * 5g for 5 to 8 instrumented vertebra * 10g fo 9 or more instrumented vertebra

Timeline

• Start date: 2022-10-25
• Primary completion: 2025-03-09
• Completion: 2025-07-01
• First posted: 2022-04-12
• Last updated: 2026-04-14

Locations

1 site across 1 country: France