Vertebral Bone Marrow Clot for Spinal Surgery

Not Applicable

Recruiting

• Conditions: Degenerative Spine Diseases
• Interventions: Biological: Vertebral bone marrow (vBMA) clot; Other: Bone allograft chips

• Registration Number: NCT05947175
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

Spinal fusion (SF) is a common orthopedic procedure to treat spinal diseases. Apart from fixation systems, the procedure requires bone grafting to further improve SF. Cell-based therapies as vertebral bone marrow aspirate (vBMA) with bone allograft were developed as alternative to bone autograft in SF. However, vBMA use is limited by the lack of a standardized procedure, of a structural texture and by the possibility of diffusion away from the implant site. Recently, the potential use of a new formulation of vBMA, named vBMA clot, has been described. The project aims at evaluating the clinical evidence and the biological features of vBMA clot associated to bone allograft for SF surgery, considering age and gender related differences. A randomized controlled trial will prove the efficacy of the treatment and advanced preclinical studies will improve the knowledge on vBMA clot regenerative and anti-inflammatory properties, exploring for the first time its antibacterial characteristics.

Detailed Description

To evaluate the efficacy of autologous vBMA clot in SF procedures in patients with degenerative spine diseases, a randomized controlled trial (RCT) will be carried out. The study will compare patients treated with autologous vBMA clot associated to bone allograft chips versus bone allograft chips alone (standard treatment), also evaluating whether patient age and gender are associated with differences in the clinical outcomes.

Study Timeline

• Study Start: 2023-05-19
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-12-31
• Study Completion: 2026-05-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• degenerative spinal disorders (based radiological diagnosis)
• posterior spinal stabilization ≤ 5 levels
• age between 18-80 years at the time of surgery

Exclusion Criteria

• HIV
• HBV
• HCV
• coagulations disorders
• pregnant or breast-feeding women
• cancer
• infections
• previous spinal surgery
• radio- chemotherapy
• myeloproliferative disease
• chronic steroid medication, thyroxin, immunodepression

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group - vertebral bone marrow (vBMA) clot	Vertebral bone marrow (vBMA) clot	Bone allograft chips will be obtained from Istituto Ortopedico Rizzoli while 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 associated with bone allograft chips 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 associated to bone allograft chips will be applied on each side of the vertebra according to the number of segments to be fused.
Control - bone allograft chips	Bone allograft chips	Bone allograft chips will be obtained from Istituto Ortopedico Rizzoli. In detail, conventional posterior approach for lumbar SF will be performed. After the positioning of pedicle screws, the decompression of the cauda and nerve roots will be achieved with a hemilaminectomy and foraminotomy. Bone allograft chips alone 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.

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 1, 3, 6, 12 months of FU, 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
Re-operation rate	12 month	The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
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)
Short Form Health Survey 36	12 months	Short Form Health Survey 36 (SF-36) (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