Allograft Alone Versus Allograft With Bone Marrow Concentrate for the Healing of the Instrumented Posterolateral Lumbar Fusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Primary Endpoint
- The improvement of the fusion of the posterolateral fusion measured on X-rays
Study Overview
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.
Study Design
- Study Type
- Interventional
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
The improvement of the fusion of the posterolateral fusion measured on X-rays
Time Frame: 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.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Komzak Martin, M.D.
Principal Investigator
Hospital Znojmo