Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01603836
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : May 23, 2012
Sponsor:
Information provided by (Responsible Party):
Komzak Martin, M.D., Hospital Znojmo

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.

Condition or disease Intervention/treatment Phase
Spondyloarthrosis, Spondylosis Biological: bone allogaft with bone marrow concentrate Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Allograft Alone Versus Allograft With Bone Marrow Concentrate for the Healing of the Instrumented Posterolateral Lumbar Fusion
Study Start Date : February 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Layout table for additonal information
Responsible Party: Komzak Martin, M.D., Principal Investigator, Hospital Znojmo
ClinicalTrials.gov Identifier: NCT01603836     History of Changes
Other Study ID Numbers: PLFBMC
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012
Keywords provided by Komzak Martin, M.D., Hospital Znojmo:
Lumbar spine
Posterolateral fusion
Allograft
Bone marrow concentrate
Mesenchymal stem cells
Fusion rate
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases