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

B

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

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

Trial contacts and locations

1

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Central trial contact

Lisa Boue; Stéphane BOURRET

Data sourced from clinicaltrials.gov

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