Study Confirms or Refutes the Hypothesis That the Autologous Bone Marrow Concentrate Together With the Allograft is a Better Alternative for the Posterolateral Fusion in Spine Surgery Than the Allograft Alone

Hospital Znojmo80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Spondyloarthrosis, Spondylosis

Interventions

bone allogaft with bone marrow concentrateBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

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.

Time frame: 12 months after the surgery

The improvement of the fusion of the posterolateral fusion measured on X-rays and CT scans.

Time frame: 24months after the surgery

Data from ClinicalTrials.gov

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