Bone Marrow Clot for Posterior Lumbar Fusion

Spinal Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05936047
• Other study ID #: CVOD.clot
• Status: Completed
• Phase: N/A
• Start date: November 27, 2020
• Est. completion date: June 27, 2023

Study information

• Verified date: October 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 27, 2023
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Fusion

Intervention

Biological:
• Vertebral bone marrow clot
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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

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