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

NCT ID: NCT01603836

Last Updated: 2012-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-03-31

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.

Conditions

Spondyloarthrosis, Spondylosis

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

bone marrow concentrate

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.

Group Type: EXPERIMENTAL

bone allogaft with bone marrow concentrate

Intervention Type: BIOLOGICAL

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

bone 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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Znojmo

OTHER

Sponsor Role: lead

Responsible Party

Komzak Martin, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PLFBMC

Identifier Type: -

Identifier Source: org_study_id