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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
The clotted 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.
Bone allograft chips will be obtained from Musculoskeletal Tissue Bank at IRCCS Istituto Ortopedico Rizzoli.
Istituto Ortopedico Rizzoli
Bologna, BO, Italy
RECRUITINGBrantigan 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 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).
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 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).
Time frame: 1 month
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 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).
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 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).
Time frame: 6 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 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).
Time frame: 12 months
Re-operation rate
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Time frame: At baseline (day 0)
Re-operation rate
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Time frame: 1 month
Re-operation rate
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Time frame: 3 month
Re-operation rate
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Time frame: 6 month
Re-operation rate
The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.
Time frame: 12 month
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: 1 month
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)
Time frame: 6 months
Visual Analogue Score
Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)
Time frame: 12 months
Oswestry Disability Index
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Time frame: At baseline (day 0)
Oswestry Disability Index
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Time frame: 1 month
Oswestry Disability Index
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Time frame: 3 months
Oswestry Disability Index
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Time frame: 6 months
Oswestry Disability Index
Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)
Time frame: 12 months
Short Form Health Survey 36
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Time frame: At baseline (day 0)
Short Form Health Survey 36
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Time frame: 1 month
Short Form Health Survey 36
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Time frame: 3 months
Short Form Health Survey 36
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Time frame: 6 months
Short Form Health Survey 36
Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)
Time frame: 12 months