Degenerative Disk DiseaseAPOLLONCT01452022
Performance of Inductigraft in Spinal Fusion
A study testing Inductigraft in people with Degenerative Disk Disease and Spinal Stenosis of Lumbar Region, run by Baxter Healthcare Corporation at 15 sites in 5 countries.
Trial summary
This is an open-label non-randomised, prospective, post market study to evaluate the performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving posterolateral lumbar spine fusion through assessment of successful fusion at 12 months post operation using x-rays and CT scans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disk Disease, Spinal Stenosis of Lumbar Region
- What is being tested?
- Inductigraft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Oct 2011to Aug 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
- Diagnosed with Degenerative Disk Disease (DDD) or lumbar spinal stenosis at one or two continuous spinal level(s), including subjects with spondylolisthesis (i.e. degenerative or isthmic)
- Has failed at least six months of non-operative treatment prior to clinical trial enrolment and is a candidate for spinal fusion surgery over one or two vertebral levels between, and including, L2 to S1 (i.e. second lumbar to first sacral)
- ≥ 18 years old and skeletally mature (epiphyses closed)
- Is, in the Investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
Who cannot join
- Has diagnosis of symptomatic DDD, spondylolisthesis, or lumbar spinal stenosis at more than two levels
- Has had prior fusion surgery at any lumbar level
- Has systemic infection or infection at the surgical site
- History of significant metabolic bone disease such as osteomalacia, autoimmune disease including rheumatoid arthritis, renal disease, hepatic disease, peripheral vascular disease, insulin dependent diabetes, Paget's disease at the involved spinal level(s) or upper motor neuron disease (positive Babinski sign)
- Has a medical condition that would interfere with post-operative assessments and care (i.e. psychiatric disease, paraplegia, quadriplegia, etc.)
- Is in poor general health or any concurrent disease process that would place the subject in excessive risk to surgery (e.g. significant circulatory, pulmonary problems, or cardiac disease)
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- Has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow up
- Is known to be pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the clinical trial
- Is participating in, or has completed within the last 30 days, another investigational clinical trial, which could confound results
- Has had three or more prior decompressive surgeries, or a prior posterior lumbar surgery resulting in significant muscle/ligament morbidity. This does NOT include facet saving techniques such as discectomy, laminotomy, and intradiscal procedures including nucleotomy, IDET procedures or annuloplasty procedures
- Has back or leg pain of unknown cause
- Morbid obesity defined as a Body Mass Index (BMI) ≥ 40
- Non-discogenic or non-stenotic cause of symptoms (e.g. tumour or fracture at the involved level)
- Has a condition or requires post-operative medications that may interfere with bone/soft tissue healing (i.e. oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.), or that effect the rate of bone metabolism unless they have undergone a 14 day wash out period prior to surgery
- Is undergoing treatment for osteoporosis (excluding osteopenia) such that in the Investigator's opinion, spinal instrumentation would be contraindicated
- Is involved in on-going litigation, concerning their medical condition.
- Has a known allergy to silicon.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
United Kingdom6 sites
University Hospital of Wales
Cardiff
Queens Medical Centre
Nottingham
Royal Preston Hospital
Preston
Salford Royal NHS Foundation Trust
Salford
Shire Southhampton Hospital
Southhampton
Musgrove Park Hospital
Tauton
Germany3 sites
Universitätsklinikum Bonn
Bonn
University of Cologne
Cologne
Ludwig-Maximilians-Universität München
München
Spain3 sites
Fundacio Hospital Universitari Vall d'Hebron
Barcelona
Hospital Clinical de Barcelona & Clinical Corachan
Barcelona
HGU Gregorio Marañón
Madrid
About this study
Official title: A Prospective Open-label Non-randomdised Multi-centre Clinical Study to Evaluate the Performance of Inductigraft in Posterolateral Fusion
This is an open-label non-randomised, prospective, post market study to evaluate the performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving posterolateral lumbar spine fusion through assessment of successful fusion at 12 months post operation using x-rays and CT scans. Quality of life questionnaires also used to assess clinical outcome measures such as pain and quality of life. Patients followed up for 24 months after surgery.
- Being tested
- Inductigraft
- Keywords
- inductigraft, osteoinductive, synthetic bone graft, posterolateral lumbar fusion, post market, lumbar spinal stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InductigraftDevice
Synthetic bone graft
| Study group | Role | What they receive |
|---|---|---|
| Inductigraft | Experimental | open label non randomised to assess performance of synthetic bone graft using the product, Inductigraft, in posterolateral lumbar fusion Receives: Device: Inductigraft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion rate
Assessed by x-ray and CT scan
Measured: 12 months after surgery
Secondary outcomes (5)
Fusion rate
fusion rate at 6 and 24 months by x-ray/CT scan
Measured: 6 and 24 months after surgery
Clinical Outcome Measure - pain
Assessed by VAS scores
Measured: 6, 12 and 24 months
Clinical Outcome measure - Quality of Life
Oswestry Disability Index
Measured: 6,12,and 24 months
Clinical Outcome measure - Quality of Life
SF-36 v2 short form, health questionnaire
Measured: 6,12,and 24 months
Adverse events
Assessment of Adverse events
Measured: 0-24 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 posted14 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disk DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apatech, Inc.
- Responsible party
- Sponsor
- Investigators
- Ciaran Bolger, Principal investigator, Beaumont Hospital, Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452022
- Sponsor's protocol ID
- INDOUS1001
- Acronym
- APOLLO
- Status last verified
- Apr 2017
- First submitted
- 5 Oct 2011
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bolger C, Jones D, Czop S. Evaluation of an increased strut porosity silicate-substituted calcium phosphate, SiCaP EP, as a synthetic bone graft substitute in spinal fusion surgery: a prospective, open-label study. Eur Spine J. 2019 Jul;28(7):1733-1742. doi: 10.1007/s00586-019-05926-1. Epub 2019 Mar 5.
PubMed 30834972
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open-label Non-randomdised Multi-centre Clinical Study to Evaluate the Performance of Inductigraft in Posterolateral Fusion
- ClinicalTrials.gov ID
- NCT01452022
- Acronym / sponsor ID
- APOLLO / INDOUS1001
- Keywords
- inductigraft, osteoinductive, synthetic bone graft, posterolateral lumbar fusion, post market, lumbar spinal stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Apatech, Inc.
- Study start
- Oct 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 14 Oct 2011 (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.
This is an open-label non-randomised, prospective, post market study to evaluate the performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving posterolateral lumbar spine fusion through assessment of successful fusion at 12 months post operation using x-rays and CT scans. Quality of life questionnaires also used to assess clinical outcome measures such as pain and quality of life. Patients followed up for 24 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inductigraft | Experimental | Device: Inductigraftopen label non randomised to assess performance of synthetic bone graft using the product, Inductigraft, in posterolateral lumbar fusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with Degenerative Disk Disease (DDD) or lumbar spinal stenosis at one or two continuous spinal level(s), including subjects with spondylolisthesis (i.e. degenerative or isthmic)
- Has failed at least six months of non-operative treatment prior to clinical trial enrolment and is a candidate for spinal fusion surgery over one or two vertebral levels between, and including, L2 to S1 (i.e. second lumbar to first sacral)
- ≥ 18 years old and skeletally mature (epiphyses closed)
- Is, in the Investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
Key exclusion criteria (17 listed)
- Has diagnosis of symptomatic DDD, spondylolisthesis, or lumbar spinal stenosis at more than two levels
- Has had prior fusion surgery at any lumbar level
- Has systemic infection or infection at the surgical site
- History of significant metabolic bone disease such as osteomalacia, autoimmune disease including rheumatoid arthritis, renal disease, hepatic disease, peripheral vascular disease, insulin dependent diabetes, Paget's disease at the involved spinal level(s) or upper motor neuron disease (positive Babinski sign)
- Has a medical condition that would interfere with post-operative assessments and care (i.e. psychiatric disease, paraplegia, quadriplegia, etc.)
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 |
|---|---|---|
| InductigraftSynthetic bone graft | Device | Inductigraft |
Primary outcome
Fusion rate
Time frame: 12 months after surgery
Assessed by x-ray and CT scan
5 secondary outcomes
Fusion rate
Time frame: 6 and 24 months after surgery
Clinical Outcome Measure - pain
Time frame: 6, 12 and 24 months
Clinical Outcome measure - Quality of Life
Time frame: 6,12,and 24 months
Clinical Outcome measure - Quality of Life
Time frame: 6,12,and 24 months
Adverse events
Time frame: 0-24 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 5 Apr 2017.
- Derived from this study: PubMed 30834972Bolger C, Jones D, Czop S. Evaluation of an increased strut porosity silicate-substituted calcium phosphate, SiCaP EP, as a synthetic bone graft substitute in spinal fusion surgery: a prospective, open-label study. Eur Spine J. 2019 Jul;28(7):1733-1742. doi: 10.1007/s00586-019-05926-1. Epub 2019 Mar 5.
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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.
Ciaran Bolger principal investigator
Beaumont Hospital, Dublin
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inductigraft in people with Degenerative Disk Disease and Spinal Stenosis of Lumbar Region, run by Baxter Healthcare Corporation at 15 sites in 5 countries.
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 4 inclusion and 17 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 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom, Germany, Spain, Hungary, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Fusion rate (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?
On the ClinicalTrials.gov record for NCT01452022, which also lists 1 linked publication.
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 5 Apr 2017.