Clinical trial NCT05936047: Bone Marrow Clot for Posterior Lumbar Fusion
Official title: Efficacy of Autologous Bone Marrow Clot as Scaffold for Instrumental Posterior Lumbar Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Fusion
Keywords: Spine
Spinal fusion
Degenerative diseases
Vertebral bone marrow
Clot
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Brantigan classification
timeFrame: At baseline (day 0)
measure: Brantigan classification
timeFrame: 3 months
measure: Brantigan classification
timeFrame: 12 months
Secondary outcomes:
measure: Visual Analogue Score
timeFrame: At baseline (day 0)
measure: Visual Analogue Score
timeFrame: 3 months
measure: Visual Analogue Score
timeFrame: 12 months
measure: Oswestry Disability Index
timeFrame: At baseline (day 0)
measure: Oswestry Disability Index
timeFrame: 3 months
measure: Oswestry Disability Index
timeFrame: 12 months
measure: EuroQoL-5L (EQ-5L)
timeFrame: At baseline (day 0)
measure: EuroQoL-5L
timeFrame: 3 months
measure: EuroQoL-5L
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
Study officials:
References:
citation: Salamanna F, Contartese D, Giavaresi G, Sicuro L, Barbanti Brodano G, Gasbarrini A, Fini M. A Rationale for the Use of Clotted Vertebral Bone Marrow to Aid Tissue Regeneration Following Spinal Surgery. Sci Rep. 2020 Mar 5;10(1):4115. doi: 10.1038/s41598-020-60934-2.
citation: Salamanna F, Contartese D, Nicoli Aldini N, Barbanti Brodano G, Griffoni C, Gasbarrini A, Fini M. Bone marrow aspirate clot: A technical complication or a smart approach for musculoskeletal tissue regeneration? J Cell Physiol. 2018 Apr;233(4):2723-2732. doi: 10.1002/jcp.26065. Epub 2017 Jul 24.
citation: Salamanna F, Contartese D, Borsari V, Pagani S, Barbanti Brodano G, Griffoni C, Ricci A, Gasbarrini A, Fini M. Two Hits for Bone Regeneration in Aged Patients: Vertebral Bone Marrow Clot as a Biological Scaffold and Powerful Source of Mesenchymal Stem Cells. Front Bioeng Biotechnol. 2022 Jan 18;9:807679. doi: 10.3389/fbioe.2021.807679. eCollection 2021.