Degenerative Spine Diseases
Conditions
Keywords
Spine, Spinal fusion, Degenerative diseases, Vertebral bone marrow, Clot
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.
Interventions
BIOLOGICALVertebral bone marrow (vBMA) clot
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.
OTHERBone allograft chips
Bone allograft chips will be obtained from Musculoskeletal Tissue Bank at IRCCS Istituto Ortopedico Rizzoli.
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brantigan classification | At baseline (day 0) | 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
| Measure | Time frame | Description |
|---|---|---|
| Re-operation rate | At baseline (day 0) | The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification. |
| Visual Analogue Score | At baseline (day 0) | Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain) |
| Oswestry Disability Index | At baseline (day 0) | Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability) |
| Short Form Health Survey 36 | At baseline (day 0) | Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes) |
Countries
Italy
Outcome results
None listed