NCT05936047 - Bone Marrow Clot for Posterior Lumbar Fusion | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

10

Conditions

Spinal Fusion

Interventions

Vertebral bone marrow clotBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Ortopedico Rizzoli

Bologna, BO, Italy

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 12 months

Secondary Outcomes

Visual Analogue Score

Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)

Time frame: At baseline (day 0)

Visual Analogue Score

Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)

Time frame: 3 months

Visual Analogue Score