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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Komzak Martin, M.D., Hospital Znojmo
ClinicalTrials.gov Identifier:
NCT01603836
First received: May 15, 2012
Last updated: May 20, 2012
Last verified: May 2012
  Purpose

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 Intervention
Spondyloarthrosis, Spondylosis
Biological: bone allogaft with bone marrow concentrate

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Allograft Alone Versus Allograft With Bone Marrow Concentrate for the Healing of the Instrumented Posterolateral Lumbar Fusion

Resource links provided by NLM:


Further study details as provided by Hospital Znojmo:

Primary Outcome Measures:
  • The improvement of the fusion of the posterolateral fusion measured on X-rays [ Time Frame: 12 months after the surgery ] [ Designated as safety issue: Yes ]
    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.

  • The improvement of the fusion of the posterolateral fusion measured on X-rays and CT scans. [ Time Frame: 24months after the surgery ] [ Designated as safety issue: Yes ]
    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
Study Start Date: February 2009
Study Completion Date: March 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 89 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Komzak Martin, M.D., Principal Investigator, Hospital Znojmo
ClinicalTrials.gov Identifier: NCT01603836     History of Changes
Other Study ID Numbers: PLFBMC
Study First Received: May 15, 2012
Last Updated: May 20, 2012
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Hospital Znojmo:
Lumbar spine
Posterolateral fusion
Allograft
Bone marrow concentrate
Mesenchymal stem cells
Fusion rate

Additional relevant MeSH terms:
Spondylosis
Spondylarthropathies
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylarthritis
Spondylitis
Arthritis
Joint Diseases

ClinicalTrials.gov processed this record on August 18, 2014