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

Not Applicable

Recruiting

• Conditions: Spinal Deformity; Hemostatics; Hemostasis; Spinal Fusion
• Interventions: Device: Control Group; Device: ARISTA

• Registration Number: NCT05323448
• Lead Sponsor: Polyclinique Bordeaux Nord Aquitaine

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-12
• Study Start: 2022-10-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control Group	Participant will not receive the ARISTA-AH hemostatic agent.
ARISTA	ARISTA	ARISTA-AH will be applied directly within the wound before closure.

Primary Outcome Measures

Name	Time	Method
Blood loss within the first 24 hours after posterior spinal fusion	24 hours	Blood loss calculated in ml per number of instrumented vertebra

Secondary Outcome Measures

Name	Time	Method
Blood loss within the first 48 hours after posterior spinal fusion	48 hours	Blood loss calculated in ml per number of instrumented vertebra
Total post-operative blood loss	3 Days	Cumulative blood loss observed until surgical drain removal
Improvement of back and leg pains at 3 months compared to preoperative scores	3 months	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).
Drain removal	7 Days	Delay between the date of initial surgery and the date of surgical drain removal
Incidence of any serious adverse events	3 Months	Record of any intra and postoperative complications
Estimated Blodd Loss (EBL)	7 Days	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
Hidden Blood Loss (HBL)	7 Days	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
Change in Patient's quality of life	3 months	Change from baseline in self reported 12-Item Short Form Survey (SF-12) score at 3 months.
Blood loss within the first 6 hours after posterior spinal fusion	6 hours	Blood loss calculated in ml per number of instrumented vertebra
Detection of any early post-operative haematoma	7 Days	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
Assessment of the Oswestry Disability Index	3 months	Change from baseline in self reported Oswestry Disability Index (ODI) score at 3 months.
Length of stay	7 Days	Length of stay is the delay between the date of admission and the date of discharge for each patient.
Detection of any haemostasis disorder	3 Months	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.

Trial Locations

Locations (1)

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France