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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 September 2016 |
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Main ID: |
NCT01618435 |
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Date of registration:
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08/05/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Spondylodesis Operation in the Elderly With Spinal Stenosis Due to Degenerative Spondylolisthesis
IVANOS |
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Scientific title:
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The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Spondylodesis Operation |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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108 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01618435 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Michael K Jacobsen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rygkirurgisk sektor Middelfart |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Age minimum:
60 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Spinal Stenosis
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Intervention(s)
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Biological: i-FACTOR
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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