Ignite Creation Date:
2024-05-06 @ 12:35 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01618435
Status:
UNKNOWN
Last Update Posted:
2016-09-07
First Post:
2012-05-08
Brief Title:
The Clinical Effect of i-FACTOR Versus Allograft in Non-instrumented Posterolateral Spondylodesis Operation in the Elderly With Spinal Stenosis Due to Degenerative Spondylolisthesis
Sponsor:
Sygehus Lillebaelt
Organization:
Sygehus Lillebaelt
Study Overview
Official Title:
The Clinical Effect of i-FACTOR Versus Allograft in Non-instrumented Posterolateral Spondylodesis Operation
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IVANOS
Brief 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 neurogenic claudicationGoh 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 painChristensen FB et alHee HT and WongMcGregor AH FAU - Hughes and HughesXu et al but the most optimal treatment is still debated Nevertheless a decompression and if needed a spinal fusion is recommendedAusman
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 importantAndersen et alAndersen et alGirardo et alKornblum 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 diseaseThorwarth et al 5648-57Thorwarth et al 789-95Wenz Oesch and Horst 1599-606Scarano et al 318-24Kubler 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
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 painChristensen FB et alHee HT and WongMcGregor AH FAU - Hughes and HughesXu et al but the most optimal treatment is still debated Nevertheless a decompression and if needed a spinal fusion is recommendedAusman
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 importantAndersen et alAndersen et alGirardo et alKornblum 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 diseaseThorwarth et al 5648-57Thorwarth et al 789-95Wenz Oesch and Horst 1599-606Scarano et al 318-24Kubler 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None