The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumentated Posterolateral Fusionin The IVANOS-study
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|ClinicalTrials.gov Identifier: NCT02895555|
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : September 9, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Stenosis Low Back Pain||Procedure: i-FACTOR Procedure: Allograft||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||RCT Comparing i-FACTOR and Allograft in Spinal Fusion Surgery|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Active Comparator: Allograft group, standard treatment
Control group, standard treatment. Aprox 50 g pr level fused.
Approx 50 g of allograft bone in the fused site
i-FACTOR putty in the operation site. Fda approved. Aprox 5 ml pr level fused.
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.
Other Name: P15
- Oswestry disability index [ Time Frame: At 24 months ]questionnaire
- Dallas pain questionnaire [ Time Frame: At 24 months ]questionnaire
- Walking distance [ Time Frame: At 24 months ]measuring distance
- EQ5D [ Time Frame: At 24 months ]questionnaire
- SF-36 [ Time Frame: At 24 months ]questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895555
|Middelfart Spine Surgery|
|Middelfart, Region of Southern Denmark, Denmark, 5500|
|Middelfart spine surgery research department|
|Middelfart, Denmark, 5500|
|Principal Investigator:||Michael k Jacobsen, MD||Department of spine surgery of Southern Denmark|