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

Launched by POLYCLINIQUE BORDEAUX NORD AQUITAINE · Apr 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a product called ARISTA-AH, which is being tested to see how well it helps stop bleeding after a specific type of spine surgery known as posterior long-segment spinal fusion. This surgery involves connecting several vertebrae in the lower back to correct problems like spinal deformities. The goal is to find out if ARISTA-AH can effectively restore hemostasis, which means stopping bleeding during and after the surgery.

To be eligible for this trial, patients must be between the ages of 65 and 74 and scheduled for a specific type of spine surgery that involves at least five connected vertebrae. They must also have a surgical drain placed at the site of the operation to help manage fluid. However, patients who are under 18, have certain blood disorders or infections, are pregnant, or have allergies to the study device cannot participate. Those who join the trial will help researchers learn about the effects of ARISTA-AH and how it can improve safety during spine surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient eligible to a posterior lumbar or thoraco-lumbar long-segment spinal fusion.
• 2. Surgery targeting at least 5 adjacent vertebra combined with one of the following procedure:
• • 1. Intersomatic bone graft;
• • 2. Pedicle substraction osteotomy;
• • 3. Any other intervertebral osteotomy (e.g. Smith-Petersen osteotomy);
• • 3. The use of a surgical drain inserted at the operative site is mandatory (suction drain and other drain are eligible);
• Exclusion Criteria:
• • 1. Subject under the age of 18 years old;
• • 2. Subject with a known haemostatic disorder;
• • 3. Subject with any infection or any immune system disorder;
• • 4. Subject not eligible to a posterior spinal surgery;
• • 5. Subject with a known allergy or any contraindication to the use of the study device;
• • 6. Currently pregnant or planning pregnancy;
• • 7. Prisoner or a ward of the state;
• • 8. Subject no willing to participate in the study;
• • 9. Subject not affiliated to a social security insurance.