The aim of this study is to assess the efficacy of the ARISTA AH for restoring hemostasis following a long segment posterior spinal fusion.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent).
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
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
RECRUITINGBlood loss within the first 24 hours after posterior spinal fusion
Blood loss calculated in ml per number of instrumented vertebra
Time frame: 24 hours
Blood loss within the first 6 hours after posterior spinal fusion
Blood loss calculated in ml per number of instrumented vertebra
Time frame: 6 hours
Blood loss within the first 48 hours after posterior spinal fusion
Blood loss calculated in ml per number of instrumented vertebra
Time frame: 48 hours
Total post-operative blood loss
Cumulative blood loss observed until surgical drain removal
Time frame: 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
Time frame: 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
Time frame: 7 Days
Drain removal
Delay between the date of initial surgery and the date of surgical drain removal
Time frame: 7 Days
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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
Time frame: 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).
Time frame: 3 months
Assessment of the Oswestry Disability Index
Change from baseline in self reported Oswestry Disability Index (ODI) score at 3 months.
Time frame: 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.
Time frame: 3 months
Length of stay
Length of stay is the delay between the date of admission and the date of discharge for each patient.
Time frame: 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.
Time frame: 3 Months
Incidence of any serious adverse events
Record of any intra and postoperative complications
Time frame: 3 Months