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 Znojmo

Status: Completed

Conditions: Spondyloarthrosis, Spondylosis

Treatments: Biological: bone allogaft with bone marrow concentrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01603836

PLFBMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 45 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 1 patient group

bone marrow concentrate

Experimental group

Description:

In forty cases, the posterolateral fusion 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.

Treatment:

Biological: bone allogaft with bone marrow concentrate