Bone Marrow Clot for Posterior Lumbar Fusion

Study Overview
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Brief Summary
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Bone marrow aspirate (BMA) in association to graft substitutes has long been introduced as a promising alternative to iliac crest bone graft in spinal fusion. However, BMA use is limited by the absence of a standardized technique, of a physical texture and by the possibility of dispersion away from the implant site. Recently, the potential use of a new formulation of BMA, named BMA clot, has been preclinically described. A prospective pilot clinical study designed to assessing the safety and efficacy of autologous vertebral BMA (vBMA) clot as multifunctional bio-scaffold in instrumental posterior lumbar fusion will be performed.

Official Title
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Efficacy of Autologous Bone Marrow Clot as Scaffold for Instrumental Posterior Lumbar Fusion

Conditions
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Spinal Fusion

Intervention / Treatment
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* Biological: Vertebral bone marrow clot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients over the age of 18 at the time of surgery symptomatic degenerative spine disease needing posterior fusion at the lumbar tract Exclusion Criteria: any form of local or systemic infections, inflammatory or autoimmune disease coagulation disorders tumor diseases alcohol or drug abuse pregnancy chemotherapeutic drugs that might interfere with bone regeneration processes revision surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The clotted vertebral bone marrow aspirate (vBMA) will be obtained from vertebral bone marrow aspirate.The vBMA clot contain mesenchymal stem cells (MSCs), growth factors, platelet and osteogenic and anti-inflammatory mediators. | Biological: Vertebral bone marrow clot<br>* vBMA will be harvested from each patient vertebral pedicle with the preparation of the site for pedicle screw insertion during spinal surgery. After the positioning of pedicle screws, the decompression of the cauda and nerve roots will be achieved with a hemilaminectomy and foraminotomy. vBMA clot will be opposed on the hemi-laminae and transvers process on the contralateral side of the hemilaminectomy. On the hemilaminectomy side, foramino-arthrectomy will be performed to insert the interbody fusion cage if necessary. After aspiration, the vBMA will be clotted and used for surgical procedure. vBMA clot will be applied on each side of the vertebra according to the number of segments to be fused.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brantigan classification | Improvement of spinal fusion rate and time in patients treated with vBMA clot associated to bone allograft chips in comparison to bone allograft chips alone, also considering age and gender differences. CT-scan and X-ray, perform pre-operatively and at FUs, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate). | At baseline (day 0) | 
| Brantigan classification | Improvement of spinal fusion rate and time in patients treated with vBMA clot associated to bone allograft chips in comparison to bone allograft chips alone, also considering age and gender differences. CT-scan and X-ray, perform pre-operatively and at FUs, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate). | 3 months | 
| Brantigan classification | Improvement of spinal fusion rate and time in patients treated with vBMA clot associated to bone allograft chips in comparison to bone allograft chips alone, also considering age and gender differences. CT-scan and X-ray, perform pre-operatively and at FUs, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Score | Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain) | At baseline (day 0) | 
| Visual Analogue Score | Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain) | 3 months | 
| Visual Analogue Score | Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain) | 12 months | 
| Oswestry Disability Index | Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability) | At baseline (day 0) | 
| Oswestry Disability Index | Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability) | 3 months | 
| Oswestry Disability Index | Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability) | 12 months | 
| EuroQoL-5L (EQ-5L) | EuroQoL-5L (EQ-5L) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes) | At baseline (day 0) | 
| EuroQoL-5L | EuroQoL-5L (EQ-5L) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes) | 3 months | 
| EuroQoL-5L | EuroQoL-5L (EQ-5L) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spine, Spinal fusion, Degenerative diseases, Vertebral bone marrow, Clot