Clinical trial NCT05323448: Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
Official title: Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemostatics
Hemostasis
Spinal Deformity
Spinal Fusion
Keywords: ARISTA-TM
Posterior Spinal Fusion
Spinal surgery
Spinal deformity
Hemostasis
Lead sponsor: Polyclinique Bordeaux Nord Aquitaine
Sponsor class: OTHER
Collaborators: name: Bard Ltd
First posted: 2022-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Blood loss within the first 24 hours after posterior spinal fusion
timeFrame: 24 hours
Secondary outcomes:
measure: Blood loss within the first 6 hours after posterior spinal fusion
timeFrame: 6 hours
measure: Blood loss within the first 48 hours after posterior spinal fusion
timeFrame: 48 hours
measure: Total post-operative blood loss
timeFrame: 3 Days
measure: Estimated Blodd Loss (EBL)
timeFrame: 7 Days
measure: Hidden Blood Loss (HBL)
timeFrame: 7 Days
measure: Drain removal
timeFrame: 7 Days
measure: Detection of any early post-operative haematoma
timeFrame: 7 Days
measure: Improvement of back and leg pains at 3 months compared to preoperative scores
timeFrame: 3 months
measure: Assessment of the Oswestry Disability Index
timeFrame: 3 months
measure: Change in Patient's quality of life
timeFrame: 3 months
measure: Length of stay
timeFrame: 7 Days
measure: Detection of any haemostasis disorder
timeFrame: 3 Months
measure: Incidence of any serious adverse events
timeFrame: 3 Months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
Study officials:
affiliation: VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine
name: Jean Charles LE HUEC, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: