Spinal StenosisIVANOSNCT02895555
The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Fusion The IVANOS-study
A study testing i-FACTOR and Allograft in people with Spinal Stenosis and Low Back Pain, run by Spine Centre of Southern Denmark at 1 site 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 to 100 years
- Conditions the study is for
- Spinal Stenosis, Low Back Pain
- What is being tested?
- i-FACTOR and Allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Sep 2020
- 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal stenosis, listhesis grade 1-2 (>3 mm), facet joint arthrosis and flavum 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, valve prothesis 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
1 site in 1 country.
About this study
Official title: RCT Comparing i-FACTOR and Allograft in Spinal Fusion Surgery
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 claudicatio(Goh KJ FAU - Khalifa et al.). LSS occurs in a combination of degenerative changes in the lower back, including hypertrophy of the ligamentum flavum, 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.
The investigators want to se whether i-FACTOR improves clinical outcomes compared to using allograft in spinal fusion in the elderly, and thereby find an improved methods operating this difficult patient population.
The hypothesis is, that there is no difference in clinical outcomes whether you use i-FACTOR or allograft i non-instrumented spinal fusion surgery in patients with spinal stenosis due to degenerative listhesis.
Read the detailed description
Se above
- Conditions
- Spinal Stenosis, Low Back Pain
- Being tested
- i-FACTOR, Allograft
- Keywords
- Oswestry disability index (ODI)
- Medical subject headings
- Spinal Stenosis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-FACTORProcedure or surgery
Also called P15
Between 5-10 CC i-FACTOR putty mixed with local harvested autograft pr level spondylodesis compared to 30 grams of allograft pr level mixed with local harvested allograft.
AllograftProcedure or surgery
Approx 50 g of allograft bone in the fused site
| Study group | Role | What they receive |
|---|---|---|
| Allograft group, standard treatment | Active comparator | Control group, standard treatment. Approx 50 g pr level fused. Receives: Procedure: Allograft |
| i-FACTOR | Experimental | i-FACTOR putty in the operation site. Fda approved. Approx 5 ml pr level fused. Receives: Procedure: i-FACTOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability index
questionnaire
Measured: At 60 months
Secondary outcomes (5)
Dallas pain questionnaire
questionnaire
Measured: At 24 months
Walking distance
measuring distance
Measured: At 24 months
EQ5D
questionnaire
Measured: At 60 months
SF-36
questionnaire
Measured: At 60 months
Fusion status yes/no
Obtained by CT-scan
Measured: At 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startMar 2012
- Primary completionSep 2020
- Study completionSep 2020
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spine Centre of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Ortotech, CeraPedics, Inc
- Responsible party
- Principal investigator, Karen Højmark Hansen, Spine Centre of Southern Denmark
- Investigators
- Mikkel Andersen, MD, Principal investigator, Department of spine surgery of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895555
- Sponsor's protocol ID
- 20120012
- Other IDs
- 20180146
- Acronym
- IVANOS
- Status last verified
- Nov 2018
- First submitted
- 24 Jun 2013
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Comparing i-FACTOR and Allograft in Spinal Fusion Surgery
- ClinicalTrials.gov ID
- NCT02895555
- Acronym / sponsor ID
- IVANOS / 20120012
- Conditions
- Spinal Stenosis, Low Back Pain
- Keywords
- Oswestry disability index (ODI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Spine Centre of Southern DenmarkUniversity, hospital or other
- Collaborators
- Ortotech, CeraPedics, Inc
- Study start
- Mar 2012 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 9 Sep 2016 (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 claudicatio(Goh KJ FAU - Khalifa et al.). LSS occurs in a combination of degenerative changes in the lower back, including hypertrophy of the ligamentum flavum, 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.
The investigators want to se whether i-FACTOR improves clinical outcomes compared to using allograft in spinal fusion in the elderly, and thereby find an improved methods operating this difficult patient population.
The hypothesis is, that there is no difference in clinical outcomes whether you use i-FACTOR or allograft i non-instrumented spinal fusion surgery in patients with spinal stenosis due to degenerative listhesis.
Detailed description
Se above
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 |
|---|---|---|
| Allograft group, standard treatment | Active comparator | Procedure: AllograftControl group, standard treatment. Approx 50 g pr level fused. |
| i-FACTOR | Experimental | Procedure: i-FACTORi-FACTOR putty in the operation site. Fda approved. Approx 5 ml pr level fused. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spinal stenosis, listhesis grade 1-2 (>3 mm), facet joint arthrosis and flavum 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, valve prothesis 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: P15Between 5-10 CC i-FACTOR putty mixed with local harvested autograft pr level spondylodesis compared to 30 grams of allograft pr level mixed with local harvested allograft. | Procedure or surgery | i-FACTOR |
| AllograftApprox 50 g of allograft bone in the fused site | Procedure or surgery | Allograft group, standard treatment |
Primary outcome
Oswestry disability index
Time frame: At 60 months
questionnaire
5 secondary outcomes
Dallas pain questionnaire
Time frame: At 24 months
Walking distance
Time frame: At 24 months
EQ5D
Time frame: At 60 months
SF-36
Time frame: At 60 months
Fusion status yes/no
Time frame: At 60 months
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 19 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Mikkel Andersen, MD principal investigator
Department of spine surgery of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-FACTOR and Allograft in people with Spinal Stenosis and Low Back Pain, run by Spine Centre of Southern Denmark at 1 site 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: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 (time frame: At 60 months). 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 19 Apr 2024.