Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
Polyclinique Bordeaux Nord Aquitaine
100 participants
Oct 25, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Patient eligible to a posterior lumbar or thoraco-lumbar long-segment spinal fusion.
- Surgery targeting at least 5 adjacent vertebra combined with one of the following procedure:
- Intersomatic bone graft;
- Pedicle substraction osteotomy;
- Any other intervertebral osteotomy (e.g. Smith-Petersen osteotomy);
- The use of a surgical drain inserted at the operative site is mandatory (suction drain and other drain are eligible);
Exclusion Criteria9
- Subject under the age of 18 years old;
- Subject with a known haemostatic disorder;
- Subject with any infection or any immune system disorder;
- Subject not eligible to a posterior spinal surgery;
- Subject with a known allergy or any contraindication to the use of the study device;
- Currently pregnant or planning pregnancy;
- Prisoner or a ward of the state;
- Subject no willing to participate in the study;
- Subject not affiliated to a social security insurance.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent).
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05323448