Fusion of Spine, Lumbar RegionNCT03331159
Evaluation of Fusion After ALIF With an Osteoinductive Material or With Homologus Bone
A study testing NanoBone and Homologous Bone in people with Fusion of Spine, Lumbar Region, run by Johann Wolfgang Goethe University Hospital.
Trial summary
The aim of this study was to determine whether instrumented anterior lumbar interbody Fusion with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) was associated with superior radiological and clinical outcomes at 12 months follow-up compared with instrumented ALIF with homologous bone Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fusion of Spine, Lumbar Region
- What is being tested?
- NanoBone and Homologous Bone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2012to 31 Oct 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic low back pain
- sensorimotor deficits
- radiculopathy and spinal claudication symptoms, all caused by degenerative changes in the lumbar spine, which were resistant to conservative pain therapy and / or physiotherapy
Who cannot join
- previous surgeries in the abdominal Region
- previous fusion surgery in the lumbar spine.
About this study
Official title: Evaluation of Fusion After Anterior Lumbar Interbody Fusion With a New Osteoinductive Bone Substitute Material: a First Randomized Clinical Trial
The aim of this study was to determine whether instrumented anterior lumbar interbody Fusion with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) was associated with superior radiological and clinical outcomes at 12 months follow-up compared with instrumented ALIF with homologous bone
Read the detailed description
This randomized clinical trial included two groups of 20 mature patients with mono- or multisegmental degenerative disease of the lumbar spine who were suitable to undergo mono- or bisegmental ALIF fusion at the level L4/L5 and L5/S1 with a carbon fiber reinforced polymer ALIF cage filled with either NH-SiO2 or homologous bone (HB). Patients were followed 12 months postoperatively. The primary aim was to compare postoperative disability as measured by the Oswestry Disability Index (ODI). Secondary aims were to compare postoperative radiographic outcomes and differences in pain and quality of life between these groups.
- Conditions
- Fusion of Spine, Lumbar Region
- Being tested
- NanoBone, Homologous Bone
- Keywords
- Lumbar Fusion, Hydroxyapatite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoBoneDevice
Cage was filled with nanocrystalline hydroxyapatite embedded in a silica gel matrix
Homologous BoneDevice
Cage was filled with homologous bone
| Study group | Role | What they receive |
|---|---|---|
| NanoBone | Experimental | The participants were treated with anterior lumbar interbody fusion (ALIF) with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) Receives: Device: NanoBone |
| Homologous bone | Active comparator | The participants were treated with anterior lumbar interbody fusion (ALIF) with homologous bone Receives: Device: Homologous Bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Postoperative disability as measured by the Oswestry Disability Index (ODI)
Measured: 12 months after surgery
Secondary outcomes (1)
Fusion rate
Postoperative radiographic Fusion rate
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Jul 2012
- Primary completion31 Oct 2013
- Study completion31 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fusion of Spine, Lumbar RegionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad ARAB MOTLAGH, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331159
- Sponsor's protocol ID
- NanoBone - ALIF
- Status last verified
- Oct 2017
- First submitted
- 29 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fusion After Anterior Lumbar Interbody Fusion With a New Osteoinductive Bone Substitute Material: a First Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03331159
- Acronym / sponsor ID
- NanoBone - ALIF
- Conditions
- Fusion of Spine, Lumbar Region
- Keywords
- Lumbar Fusion, Hydroxyapatite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 31 Oct 2013 (actual)
- Study completion
- 31 Oct 2015 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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 aim of this study was to determine whether instrumented anterior lumbar interbody Fusion with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) was associated with superior radiological and clinical outcomes at 12 months follow-up compared with instrumented ALIF with homologous bone
Detailed description
This randomized clinical trial included two groups of 20 mature patients with mono- or multisegmental degenerative disease of the lumbar spine who were suitable to undergo mono- or bisegmental ALIF fusion at the level L4/L5 and L5/S1 with a carbon fiber reinforced polymer ALIF cage filled with either NH-SiO2 or homologous bone (HB). Patients were followed 12 months postoperatively. The primary aim was to compare postoperative disability as measured by the Oswestry Disability Index (ODI). Secondary aims were to compare postoperative radiographic outcomes and differences in pain and quality of life between these groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| NanoBone | Experimental | Device: NanoBoneThe participants were treated with anterior lumbar interbody fusion (ALIF) with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) |
| Homologous bone | Active comparator | Device: Homologous BoneThe participants were treated with anterior lumbar interbody fusion (ALIF) with homologous bone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic low back pain
- sensorimotor deficits
- radiculopathy and spinal claudication symptoms, all caused by degenerative changes in the lumbar spine, which were resistant to conservative pain therapy and / or physiotherapy
Key exclusion criteria (2 listed)
- previous surgeries in the abdominal Region
- previous fusion surgery in the lumbar spine.
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 |
|---|---|---|
| NanoBoneCage was filled with nanocrystalline hydroxyapatite embedded in a silica gel matrix | Device | NanoBone |
| Homologous BoneCage was filled with homologous bone | Device | Homologous bone |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: 12 months after surgery
Postoperative disability as measured by the Oswestry Disability Index (ODI)
1 secondary outcome
Fusion rate
Time frame: 12 months after surgery
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 6 Nov 2017.
- Individual participant dataSharing planned: No
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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 NanoBone and Homologous Bone in people with Fusion of Spine, Lumbar Region, run by Johann Wolfgang Goethe University Hospital.
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 3 inclusion and 2 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 6 Nov 2017. 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?
Oswestry Disability Index (ODI) (time frame: 12 months after surgery). 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 6 Nov 2017.