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

Bordeaux Nord Aquitaine Group (GBNA)

Status: Enrolling

Conditions: Hemostasis; Hemostatics; Spinal Fusion; Spinal Deformity

Treatments: Device: Control Group; Device: ARISTA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05323448

2022-ORT01

Details and patient eligibility

About

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

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

ARISTA

Experimental group

Description:

ARISTA-AH will be applied directly within the wound before closure.

Treatment:

Device: ARISTA

Control group

Experimental group

Description:

Participant will not receive the ARISTA-AH hemostatic agent.

Treatment:

Device: Control Group