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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2025-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis.

NCT05312281

Spinal Stenosis

RECRUITING NA

Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages

NCT05237908

Disk Herniated Lumbar Disc Disease Degenerative Spondylolisthesis

ACTIVE_NOT_RECRUITING

LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant

NCT04631133

Chronic Low-back Pain Herniated Disc Degenerative Disc Disease +1 more

RECRUITING

The Effect of Using Autologous Platelet Rich Plasma on Posterior Lumbar Interbody Fusion

NCT03261843

Autologous Platelet Rich Plasma Effect on Bone Healing

UNKNOWN PHASE4

Instr. vs. Non-instr. Posterolateral Spinal Fusion in Patients With Spinal Stenosis and Degenerative Listhesis

NCT04166981

Spinal Stenosis Spondylolisthesis Degenerative Spinal Fusion

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemostatics Hemostasis Spinal Deformity Spinal Fusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ARISTA

ARISTA-AH will be applied directly within the wound before closure.

Group Type EXPERIMENTAL

ARISTA

Intervention Type DEVICE

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

Control group

Participant will not receive the ARISTA-AH hemostatic agent.

Group Type EXPERIMENTAL

Control Group

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Control Group

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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No