Clinical trial

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

Name

CVOD.clot

Description

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.

Trial arms

Trial start

2020-11-27

Estimated PCD

2022-07-19

Trial end

2023-06-27

Status

Completed

Treatment

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.

Arms:

Experimental

Size

Primary endpoint

Brantigan classification

At baseline (day 0)

Brantigan classification

3 months

Brantigan classification

12 months

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

Updated at

2023-10-11

1 organization

1 product

1 indication

Organization

Istituto Ortopedico Rizzoli

Product

Vertebral bone marrow clot

Indication

Spinal Fusion