The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumentated Posterolateral Fusionin The IVANOS-study

Study Overview
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Brief Summary
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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-operativ 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 recommented.(Ausman). 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 diffycult patient population. The hypothesis is, that there is no difference in clinical outcomes whether you use i-FACTOR or allograft i non-instrumentated spinal fusion surgery in patients with spinal stenosis due to degenerative listhesis.

Detailed Description
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Se above

Official Title
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RCT Comparing i-FACTOR and Allograft in Spinal Fusion Surgery

Conditions
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Spinal Stenosis, Low Back Pain

Intervention / Treatment
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* Procedure: i-FACTOR
* Procedure: Allograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spinal stenosis, listhesis grade 1-2 (>3 mm), facet joint arthrosis and flavum hypertrophya 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 obligat thromboprophylaxis treatment, including mekanical valve, (DVT with cancer/thrombofilia, 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 succes The use of steroids and bisphosfonates. Prior radiotherapy to the lower back. Haemologic disease. -

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allograft group, standard treatment<br>Control group, standard treatment. Aprox 50 g pr level fused. | Procedure: Allograft<br>* Approx 50 g of allograft bone in the fused site<br>|
| Experimental: i-FACTOR<br>i-FACTOR putty in the operation site. Fda approved. Aprox 5 ml pr level fused. | Procedure: i-FACTOR<br>* 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 aulograft.<br>* Other names: P15;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry disability index | questionnaire | At 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dallas pain questionnaire | questionnaire | At 24 months | 
| Walking distance | measuring distance | At 24 months | 
| EQ5D | questionnaire | At 24 months | 
| SF-36 | questionnaire | At 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ODI