Spondyloarthrosis, SpondylosisNCT01603836
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
A study testing bone allogaft with bone marrow concentrate in people with Spondyloarthrosis, Spondylosis, run by Hospital Znojmo.
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. Read more about this study
- Who is it for?
- Ages 45 to 89 years
- Conditions the study is for
- Spondyloarthrosis, Spondylosis
- What is being tested?
- bone allogaft with bone marrow concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- degenerative disc disease or degenerative spondylolisthesis
Who cannot join
- 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.
About this study
Official title: Allograft Alone Versus Allograft With Bone Marrow Concentrate for the Healing of the Instrumented Posterolateral Lumbar Fusion
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.
Read the 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
- Being tested
- bone allogaft with bone marrow concentrate
- Keywords
- Lumbar spine, Posterolateral fusion, Allograft, Bone marrow concentrate, Mesenchymal stem cells, Fusion rate
- Medical subject headings
- Spondylarthritis, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone allogaft with bone marrow concentrateBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| bone marrow concentrate | Experimental | 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. Receives: Biological: bone allogaft with bone marrow concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after the surgery
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.
Measured: 24months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startFeb 2009
- Primary completionMar 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondyloarthrosis, SpondylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Znojmo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Komzak Martin, M.D., Hospital Znojmo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603836
- Sponsor's protocol ID
- PLFBMC
- Status last verified
- May 2012
- First submitted
- 15 May 2012
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allograft Alone Versus Allograft With Bone Marrow Concentrate for the Healing of the Instrumented Posterolateral Lumbar Fusion
- ClinicalTrials.gov ID
- NCT01603836
- Acronym / sponsor ID
- PLFBMC
- Conditions
- Spondyloarthrosis, Spondylosis
- Keywords
- Lumbar spine, Posterolateral fusion, Allograft, Bone marrow concentrate, Mesenchymal stem cells, Fusion rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital ZnojmoUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 23 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bone marrow concentrate | Experimental | Biological: bone allogaft with bone marrow concentrateIn 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. |
Who may qualify
- Ages
- 45 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- degenerative disc disease or degenerative spondylolisthesis
Key exclusion criteria (8 listed)
- vertebral fractures,
- infections or spinal neoplasms,
- non-rigid instrumentations,
- medication affecting bone mineralization (e.g., corticosteroids),
- body mass index higher than 35,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone allogaft with bone marrow concentrateIn 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. | Biological | bone marrow concentrate |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing bone allogaft with bone marrow concentrate in people with Spondyloarthrosis, Spondylosis, run by Hospital Znojmo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of the fusion of the posterolateral fusion measured on X-rays (time frame: 12 months after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012; AzTrials last refreshed its copy on 2 Nov 2026.