Spinal Fusion Clinical Trial
Official title:
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Polyclinique Bordeaux Nord Aquitaine | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
Polyclinique Bordeaux Nord Aquitaine | Bard Ltd |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04037059 -
Impact of Body Habitus (Arm Span and Abdominal Girth) on Activities of Daily Living (ADL)
|
||
Recruiting |
NCT03883022 -
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
|
N/A | |
Not yet recruiting |
NCT06003010 -
Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients
|
N/A | |
Completed |
NCT01136590 -
Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery
|
Phase 4 | |
Completed |
NCT01235650 -
Prevalence of Inadvertent Hyperventilation During Intraoperative Anesthetic Care
|
N/A | |
Completed |
NCT03459404 -
Sufentanil NanoTab PCA System/15 mcg for Acute Post-Operative Pain in Vertebral Surgery: A Preliminary Investigation
|
||
Recruiting |
NCT05010148 -
A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain
|
Phase 3 | |
Recruiting |
NCT04605120 -
Allogeinic Bone Paste
|
N/A | |
Completed |
NCT03826329 -
Risk Factors of Second Surgery for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion
|
||
Recruiting |
NCT04601363 -
Personalized Spine Study Group (PSSG) Registry
|
||
Completed |
NCT00994656 -
Is Pleth Variability Index (PVI) a Surrogate for Pulse Pressure Variations (PPV) in Pediatric Spine Fusion (SF) Surgery?
|
N/A | |
Completed |
NCT00152152 -
Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery
|
N/A | |
Terminated |
NCT03425799 -
Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
|
Phase 3 | |
Not yet recruiting |
NCT06368245 -
Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions
|
||
Withdrawn |
NCT03908203 -
Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction
|
N/A | |
Terminated |
NCT03378973 -
The Effects of Dexmedetomidine Dose on Motor Evoked Potentials
|
Phase 4 | |
Completed |
NCT05936047 -
Bone Marrow Clot for Posterior Lumbar Fusion
|
N/A | |
Not yet recruiting |
NCT03692845 -
Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion
|
N/A | |
Completed |
NCT00152165 -
Use of Radiostereometric Analysis (RSA) Following Spinal Fusion Versus the DYNESYS Stabilization System
|
N/A | |
Recruiting |
NCT03644407 -
Galeazzi Spine Surgery RegistryGaleazzi Spine Registry: Prospective Study for Clinical Monitoring
|