Spondyloarthrosis, Spondylosis
Conditions
Keywords
Lumbar spine, Posterolateral fusion, Allograft, Bone marrow concentrate, Mesenchymal stem cells, Fusion rate
Brief summary
The use of autologous mesenchymal stem cell (MSCs) in form of the BMC in combination with allograft is an effective option how to enhance the Posterolateral Fusion (PLF) healing. Allograft by itself is not an effective material as a posterior onlay graft for the PLF in adult surgery.
Detailed description
The study was prospective, randomized, controlled and blinded. Eighty patients with degenerative disease of the lumbar spine underwent instrumented lumbar or lumbosacral PLF. In forty cases, the PLF was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.
Interventions
BIOLOGICALbone allogaft with bone marrow concentrate
In forty cases, the PLF was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.
Sponsors
Hospital Znojmo
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* degenerative disc disease or degenerative spondylolisthesis
Exclusion criteria
* vertebral fractures, * infections or spinal neoplasms, * non-rigid instrumentations, * medication affecting bone mineralization (e.g., corticosteroids), * body mass index higher than 35, * systemic diseases, * blood disease and/or immunosuppressant treatment and/or dicoumarol therapy; * immunosuppressant and/or neoplastic and/or infectious diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The improvement of the fusion of the posterolateral fusion measured on X-rays | 12 months after the surgery | Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation. |
| The improvement of the fusion of the posterolateral fusion measured on X-rays and CT scans. | 24months after the surgery | Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation. |
Outcome results
None listed