Spinal StenosisPhase 3IVANOSNCT01618435
The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Spondylodesis Operation in the Elderly With Spinal Stenosis Due to Degenerative Spondylolisthesis
A Phase 3 study testing i-FACTOR in people with Spinal Stenosis, run by Sygehus Lillebaelt at 2 sites in Denmark.
Trial summary
The average life expectancy in Denmark is increasing resulting in an increasing part of the population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back, especially when standing and walking, known as… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- i-FACTOR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2012to May 2018
- Phase
- Phase 3
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal stenosis, olisthesis grade 1-2 (>3 mm), facet joint arthrosis and flavus hypertrophia verified by a mr-scan and x-ray including maximally 2 levels ranging from L1-S1.
- A score of 6 and more on Konno´s "History of Examination Characteristic".
- Signed informed content.
Who cannot join
- Any disease demanding obligate thromboprophylaxis treatment, including mechanical valve, (DVT with cancer/thrombophilia, AMI, apoplexia cerebri, TCI, valve-operation)< 3 months, coronar metal stent < 6 weeks and coronar drug eluted/coated stent < 12 months.
- Atrial fibrillation and one of the following: Mitral stenosis, valveprothesis and apoplexia cerebri/TCI.
- Atrial fibrillation and two of the following: Heart insufficient, HT, DM, age > 75 years, EF < 35 %.
- Known cancer in the axial skeleton.
- Ongoing chemotherapy.
- Fracture i the lower back within a year prior to inclusion.
Show all 15Show fewer
- Reduced distance of walking due to non-spinal related causes.
- Candidate for more than two-level intervention.
- Dementia assessed by the MMSE
- ASA 3+4
- Age below 60 years.
- Missed 3 months of conservative treatment without success
- The use of steroids and bisphosphonates.
- Prior radiotherapy to the lower back.
- Haematologic disease.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Sygehuslillebaelt
Middelfart, DK, 5500
Rygkirurgisk sektor Middelfart
Middelfart, Region Syddanmark, 5500
About this study
Official title: The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Spondylodesis Operation
The average life expectancy in Denmark is increasing resulting in an increasing part of the population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back, especially when standing and walking, known as neurogenic claudication(Goh KJ FAU - Khalifa et al.). LSS occurs in a combination of degenerative changes in the lower back, including hypertrophy of the ligamentum flavus, arthrosis of the facet joints and bulging of the disc.
Current treatment of LSS is varied ranging from non-operative conservative treatment to operation.
Read more
Operative intervention shows very good results according to physical ability and pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.), but the most optimal treatment is still debated. Nevertheless, a decompression and, if needed, a spinal fusion is recommended.(Ausman).
Clinical improvement including decrease of pain, improved ADL-function and an increased quality of life are parameters of highest interest and the purpose of an operation is clear: Making sufficient room for the affected nerves. In addition fusion is desired achieving stability avoiding a new compression of the nerves. Studies attending these issues find a correlation between fusion and clinical outcome, why obtained fusion of the affected levels are very important(Andersen et al.;Andersen et al.;Girardo et al.;Kornblum MB FAU - Fischgrund et al.).
P-15, bound to Anorganisk Bone Mineral (ABM), called i-FACTOR®, shows fusion superiority, no side effects and no risk of transferring disease(Thorwarth et al. 5648-57;Thorwarth et al. 789-95;Wenz, Oesch, and Horst 1599-606;Scarano et al. 318-24;Kubler et al. 171-79) why the investigators find this material suited for fusion surgery in the elderly.
To the investigators knowledge this is the first prospective study comparing fusion rates and postoperative clinic with i-FACTOR vs allograft in older patients operated with decompression and spondylodesis because of spinal stenosis due to degenerative spondylolisthesis.
Hypothesis:
There are no difference in the clinical parameters measured by ODI and fusion rates comparing i-FACTOR® and allograft in non-instrumented posterolateral spondylodesis-operations in patients 60 years and older.
- Conditions
- Spinal Stenosis
- Being tested
- i-FACTOR
- Keywords
- Fusion surgery, Degenerative olisthesis, i-FACTOR, ODI, 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.
i-FACTORBiological
Also called i-FACTOR®putty, Cerapedics, USA. CE-brand 0086
i-FACTOR mixed with autologous bone from the decompression placed in the operation site for enhancing fusion
| Study group | Role | What they receive |
|---|---|---|
| Fusion, allograft | Active comparator | Allograft used for fusion in the operation site Receives: Biological: i-FACTOR |
| Fusion, i-FACTOR | Experimental | i-FACTOR used for fusion in the operation site Receives: Biological: i-FACTOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical effect of i-FACTOR® versus allograft in non-instrumented posterolateral spondylodesis operation in the elderly with spinal stenosis due to degenerative spondylolisthesis measured by ODI
Measured: 24 months postoperative
Secondary outcomes (1)
The clinical effect of i-FACTOR® versus allograft in non-instrumented posterolateral spondylodesis operation in the elderly with spinal stenosis due to degenerative spondylolisthesis assessed by fusion rates
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sygehus Lillebaelt
- Sponsor type
- University, hospital or other
- Collaborators
- CeraPedics, Inc
- Responsible party
- Principal investigator, Michael Kjaer Jacobsen, Sygehus Lillebaelt
- Investigators
- Michael K Jacobsen, MD, Principal investigator, Rygkirurgisk sektor Middelfart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618435
- Sponsor's protocol ID
- F12-04
- Acronym
- IVANOS
- Status last verified
- Sep 2016
- First submitted
- 8 May 2012
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Spondylodesis Operation
- ClinicalTrials.gov ID
- NCT01618435
- Acronym / sponsor ID
- IVANOS / F12-04
- Conditions
- Spinal Stenosis
- Keywords
- Fusion surgery, Degenerative olisthesis, i-FACTOR, ODI, Spinal stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Sygehus LillebaeltUniversity, hospital or other
- Collaborators
- CeraPedics, Inc
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- May 2018 (estimated)
- First posted
- 13 Jun 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 average life expectancy in Denmark is increasing resulting in an increasing part of the population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back, especially when standing and walking, known as neurogenic claudication(Goh KJ FAU - Khalifa et al.). LSS occurs in a combination of degenerative changes in the lower back, including hypertrophy of the ligamentum flavus, arthrosis of the facet joints and bulging of the disc.
Current treatment of LSS is varied ranging from non-operative conservative treatment to operation.
Operative intervention shows very good results according to physical ability and pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.), but the most optimal treatment is still debated. Nevertheless, a decompression and, if needed, a spinal fusion is recommended.(Ausman).
Clinical improvement including decrease of pain, improved ADL-function and an increased quality of life are parameters of highest interest and the purpose of an operation is clear: Making sufficient room for the affected nerves. In addition fusion is desired achieving stability avoiding a new compression of the nerves. Studies attending these issues find a correlation between fusion and clinical outcome, why obtained fusion of the affected levels are very important(Andersen et al.;Andersen et al.;Girardo et al.;Kornblum MB FAU - Fischgrund et al.).
P-15, bound to Anorganisk Bone Mineral (ABM), called i-FACTOR®, shows fusion superiority, no side effects and no risk of transferring disease(Thorwarth et al. 5648-57;Thorwarth et al. 789-95;Wenz, Oesch, and Horst 1599-606;Scarano et al. 318-24;Kubler et al. 171-79) why the investigators find this material suited for fusion surgery in the elderly.
To the investigators knowledge this is the first prospective study comparing fusion rates and postoperative clinic with i-FACTOR vs allograft in older patients operated with decompression and spondylodesis because of spinal stenosis due to degenerative spondylolisthesis.
Hypothesis:
There are no difference in the clinical parameters measured by ODI and fusion rates comparing i-FACTOR® and allograft in non-instrumented posterolateral spondylodesis-operations in patients 60 years and older.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fusion, allograft | Active comparator | Biological: i-FACTORAllograft used for fusion in the operation site |
| Fusion, i-FACTOR | Experimental | Biological: i-FACTORi-FACTOR used for fusion in the operation site |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spinal stenosis, olisthesis grade 1-2 (>3 mm), facet joint arthrosis and flavus hypertrophia verified by a mr-scan and x-ray including maximally 2 levels ranging from L1-S1.
- A score of 6 and more on Konno´s "History of Examination Characteristic".
- Signed informed content.
Key exclusion criteria (15 listed)
- Any disease demanding obligate thromboprophylaxis treatment, including mechanical valve, (DVT with cancer/thrombophilia, AMI, apoplexia cerebri, TCI, valve-operation)< 3 months, coronar metal stent < 6 weeks and coronar drug eluted/coated stent < 12 months.
- Atrial fibrillation and one of the following: Mitral stenosis, valveprothesis and apoplexia cerebri/TCI.
- Atrial fibrillation and two of the following: Heart insufficient, HT, DM, age > 75 years, EF < 35 %.
- Known cancer in the axial skeleton.
- Ongoing chemotherapy.
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 |
|---|---|---|
| i-FACTORAlso: i-FACTOR®putty, Cerapedics, USA. CE-brand 0086i-FACTOR mixed with autologous bone from the decompression placed in the operation site for enhancing fusion | Biological | Fusion, allograft, Fusion, i-FACTOR |
Primary outcome
The clinical effect of i-FACTOR® versus allograft in non-instrumented posterolateral spondylodesis operation in the elderly with spinal stenosis due to degenerative spondylolisthesis measured by ODI
Time frame: 24 months postoperative
1 secondary outcome
The clinical effect of i-FACTOR® versus allograft in non-instrumented posterolateral spondylodesis operation in the elderly with spinal stenosis due to degenerative spondylolisthesis assessed by fusion rates
Time frame: 12 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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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.
Michael K Jacobsen, MD principal investigator
Rygkirurgisk sektor Middelfart
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing i-FACTOR in people with Spinal Stenosis, run by Sygehus Lillebaelt at 2 sites in Denmark.
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 15 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: status not confirmed, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 clinical effect of i-FACTOR® versus allograft in non-instrumented posterolateral spondylodesis operation in the elderly with spinal stenosis due to degenerative spondylolisthesis measured by ODI (time frame: 24 months postoperative). 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 7 Sep 2016.