Status:
RECRUITING
Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
Lead Sponsor:
Polyclinique Bordeaux Nord Aquitaine
Collaborating Sponsors:
Bard Ltd
Conditions:
Hemostatics
Hemostasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05323448
Start Date
October 25 2022
End Date
February 1 2025
Last Update
November 8 2024
Active Locations (1)
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1
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33077