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

Spondyloarthrosis, Spondylosis Clinical Trial

Official title:

Allograft Alone Versus Allograft With Bone Marrow Concentrate for the Healing of the Instrumented Posterolateral Lumbar Fusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603836
• Other study ID #: PLFBMC
• Status: Completed
• Phase: N/A
• First received: May 15, 2012
• Last updated: May 20, 2012
• Start date: February 2009
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Hospital Znojmo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2012
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spondylarthropathies
• Spondyloarthrosis, Spondylosis
• Spondylosis

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Znojmo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months after the surgery
Primary	The improvement of the fusion of the posterolateral fusion measured on X-rays and CT scans.	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.	24months after the surgery