Bone Marrow Clot for Posterior Lumbar Fusion

Not Applicable

Completed

• Conditions: Spinal Fusion
• Interventions: Biological: Vertebral bone marrow clot

• Registration Number: NCT05936047
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-27
• Primary Completion: 2022-07-19
• Study Completion: 2023-06-27
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-07
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Vertebral bone marrow clot	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.

Primary Outcome Measures

Name	Time	Method
Brantigan classification	12 months	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, BO, Italy