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

Spinal Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05323448
• Other study ID #: 2022-ORT01
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2023
• Source: Polyclinique Bordeaux Nord Aquitaine
• Contact: Stéphane BOURRET
• Phone: +33556437017
• Email: s.bourret[@]bordeauxnord.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Hemostasis
• Spinal Deformity
• Spinal Fusion

Intervention

Device:
• Control Group
During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent).
• 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

Locations

Country	Name	City	State
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
Polyclinique Bordeaux Nord Aquitaine	Bard Ltd

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss within the first 24 hours after posterior spinal fusion	Blood loss calculated in ml per number of instrumented vertebra	24 hours
Secondary	Blood loss within the first 6 hours after posterior spinal fusion	Blood loss calculated in ml per number of instrumented vertebra	6 hours
Secondary	Blood loss within the first 48 hours after posterior spinal fusion	Blood loss calculated in ml per number of instrumented vertebra	48 hours
Secondary	Total post-operative blood loss	Cumulative blood loss observed until surgical drain removal	3 Days
Secondary	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
Secondary	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
Secondary	Drain removal	Delay between the date of initial surgery and the date of surgical drain removal	7 Days
Secondary	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
Secondary	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
Secondary	Assessment of the Oswestry Disability Index	Change from baseline in self reported Oswestry Disability Index (ODI) score at 3 months.	3 months
Secondary	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
Secondary	Length of stay	Length of stay is the delay between the date of admission and the date of discharge for each patient.	7 Days
Secondary	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
Secondary	Incidence of any serious adverse events	Record of any intra and postoperative complications	3 Months