CompletedNot Applicable

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

France91 participantsStarted 2022-10-25

Plain-language 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.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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);

✕. 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;

Blood loss within the first 24 hours after posterior spinal fusion

Timeframe: 24 hours

NCT IDNCT05323448

SponsorPolyclinique Bordeaux Nord Aquitaine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-09