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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Hemostatics, Hemostasis, Spinal Deformity, Spinal Fusion

Intervention / Treatment
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* Device: Control Group
* Device: ARISTA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARISTA<br>ARISTA-AH will be applied directly within the wound before closure. | Device: ARISTA<br>* During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent). Before surgical wound closure, the corresponding amount of ARISTA-AH will be applied to completely cover the bleeding site : 5g for 5 to 8 instrumented vertebra 10g fo 9 or more instrumented vertebra<br>|
| Experimental: Control group<br>Participant will not receive the ARISTA-AH hemostatic agent. | Device: Control Group<br>* During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss within the first 24 hours after posterior spinal fusion | Blood loss calculated in ml per number of instrumented vertebra | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss within the first 6 hours after posterior spinal fusion | Blood loss calculated in ml per number of instrumented vertebra | 6 hours | 
| Blood loss within the first 48 hours after posterior spinal fusion | Blood loss calculated in ml per number of instrumented vertebra | 48 hours | 
| Total post-operative blood loss | Cumulative blood loss observed until surgical drain removal | 3 Days | 
| Estimated Blodd Loss (EBL) | EBL are calculated by multiplying the perioperative difference of haemoglobin EHb (formula used: EHb = (Hb preop - Hb post-op)/Hb preop) by the patient's estimated blood volume (EBV = weight x F; F = 75 for adult males; F = 70 for adolescent males; F = 60 for females). EBL = EHb x EBV | 7 Days | 
| Hidden Blood Loss (HBL) | HBL is the difference of the estimated blood loss (EBL) with the amount of perioperative blood loss and the amount of transfusions: HBL = EBL - intraoperative blood loss + transfusion | 7 Days | 
| Drain removal | Delay between the date of initial surgery and the date of surgical drain removal | 7 Days | 
| Detection of any early post-operative haematoma | Every participant will have an early postoperative MRI (before hospital discharge) to detect the presence of any haematoma. The presence (yes/no), the size (cm2) and the gravity (symptomatic, asymptomatic) of the observed haematoma will be compared between the 2 groups | 7 Days | 
| Improvement of back and leg pains at 3 months compared to preoperative scores | Back and leg pain intensity self-report will be assessed before and after initial procedure for each patient (at 3 months) using a 0 to 10 visual analog scale (0: no pain ; 10: most imaginable pain). | 3 months | 
| Assessment of the Oswestry Disability Index | Change from baseline in self reported Oswestry Disability Index (ODI) score at 3 months. | 3 months | 
| Change in Patient's quality of life | Change from baseline in self reported 12-Item Short Form Survey (SF-12) score at 3 months. | 3 months | 
| Length of stay | Length of stay is the delay between the date of admission and the date of discharge for each patient. | 7 Days | 
| Detection of any haemostasis disorder | Proportion of subjects with any of the following complications related to haemostasis condition: delay or healing disorders, post-operative wound infection, neurological disorders, surgical disorders or any other complication directly related to haemostasis dysfunction or the use of ARISTA-AH product. | 3 Months | 
| Incidence of any serious adverse events | Record of any intra and postoperative complications | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARISTA-TM, Posterior Spinal Fusion, Spinal surgery, Spinal deformity, Hemostasis