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

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

Study Overview

• Status: Recruiting
• Conditions: Spinal Fusion; Hemostasis; Spinal Deformity; Hemostatics
• Intervention / Treatment: Device: ARISTA; Device: Control Group

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33077
    • Recruiting
    • Polyclinique Bordeaux Nord Aquitaine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARISTA; ARISTA-AH will be applied directly within the wound before closure.	Device: ARISTA; 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
Experimental: Control group; Participant will not receive the ARISTA-AH hemostatic agent.	Device: Control Group; During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Polyclinique Bordeaux Nord Aquitaine
• Collaborators: Bard Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Hemostasis; Spinal surgery; Posterior Spinal Fusion; Spinal deformity; ARISTA-TM
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2022-ORT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No