Actively Recruiting
Vertebral Bone Marrow Clot for Spinal Surgery
Led by Istituto Ortopedico Rizzoli · Updated on 2025-03-26
96
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vertebral Bone Marrow Clot for Spinal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with degenerative spinal disorders based on radiological diagnosis
- Scheduled for posterior spinal stabilization involving 5 or fewer spinal levels
- Aged between 18 and 80 years at the time of surgery
You will not qualify if you...
- Presence of HIV infection
- Presence of hepatitis B virus (HBV) infection
- Presence of hepatitis C virus (HCV) infection
- Coagulation disorders
- Pregnant or breast-feeding women
- Current cancer diagnosis
- Active infections
- Previous spinal surgery
- History of radio-chemotherapy
- Diagnosis of myeloproliferative disease
- Use of chronic steroid medication, thyroxin, or immunosuppressive therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, BO, Italy, 40136
Actively Recruiting
Research Team
F
Francesca Salamanna, PhD
CONTACT
M
Maria Sartori, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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