Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545032
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Minimal Invasive Transforaminal Lumbar Interbody Fusion for Degenerative Lumbar and Lumbosacral Spine Diseases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Minimal Invasive Transforaminal Lumbar Interbody Fusion for Degenerative Lumbar and Lumbosacral Spine Diseases Clinical and Surgical Outcome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate clinical and surgical outcome of MI-TLIF for degenerative lumbar and lumbosacral spine diseases
Detailed Description:
Approximately 70 to 85 of adults were affected by low back pain LBP at some point during their lifetimes Numerous anatomic sites can be responsible for the pain and accurate diagnosis is often difficult Degenerative lumbar lumbosacral spine diseases internal disc disruption lumbar disc herniation and facet joint arthritis as well as intra-abdominal pathology are all potential causes of LBPStott and Driscoll 2024 q Degenerative lumbar and lumbosacral spine diseases are the most rampantly prevalent healthcare problems in the world with chronic LBP being the second leading cause of adult disability The symptoms can broadly be divided into LBP and radicular symptoms in the lower extremities leading in some cases to neurogenic claudicationShokri et al 2023
As an alternative to PLIF Harms and Rolinger introduced the transforaminal lumbar interbody fusion TLIF procedure in 1982 for the management of degenerative spinal disorders that necessitate interbody fusions The impetus for the development of TLIF was to provide a more lateral approach to the disc space thus reducing the amount of thecal sac and nerve root retraction Additionally in revision cases where scar tissue hinders identification of neural structures avoidance of midline scar planes with the TLIF procedure is beneficial Moreover a circumferential fusion can be achieved from a unilateral approach with the TLIF procedure without having to expose the bilateral epidural space Karikari Isaac O MD Isaacs Robert E MD 2010
Technological advances better magnification and illumination modern tubular retractors and percutaneous screw systems and more frequent exposure of surgeons to minimally access surgery in their residency training has greatly contributed to the global success of minimal invasive transforaminal lumbar interbody fusion MI-TLIF Traditional open spinal fusion surgeries while effective are associated with considerable tissue disruption prolonged recovery times and higher risks of complicationsPrabhu et al 2022
MI-TLIFis one such advanced surgical technique designed to treat degenerative conditions of lumbar and lumbosacral spine diseases Through the tubular expander MIS-TLIF can reach the facet joints of the diseased segments MIS-TLIF effectively reduces the peeling and traction injury of the multifidus muscle prevents postoperative muscle atrophy and reduces the occurrence of postoperative chronic LBPSaela et al 2023
The MI-TLIF has shown reduced complications decreased intraoperative blood loss shorter hospital stays and recovery time and decreased postoperative narcotic usage while maintaining similar clinical outcomes and fusion rates to conventional open TLIF since its inception Hong et al 2022
The success of MI-TLIF can be attributed to the following fundamental principles 1 minimizing damage to soft tissues and avoiding destabilization of the spinal segments to achieve the surgical goal with the smallest possible operative footprint 2 utilizing a unilateral approach to achieve bilateral decompression when needed and 3 achieving neural decompression indirectly Although there is no definitive definition of MI-TLIF the lack of a precise definition has led to significant variations in how surgeons perform the procedure due to various technical nuances associated with each stepLener et al 2020
The use of minimally invasive surgical techniques represents the most recent modification of methods used to achieve lumbar interbody fusion based upon the premise that a smaller less traumatic incision should afford better recovery and outcomesJang et al 2024Hence in our study we aim to evaluate MI-TLIF for degenerative lumbar and lumbosacral spine diseases
As an alternative to PLIF Harms and Rolinger introduced the transforaminal lumbar interbody fusion TLIF procedure in 1982 for the management of degenerative spinal disorders that necessitate interbody fusions The impetus for the development of TLIF was to provide a more lateral approach to the disc space thus reducing the amount of thecal sac and nerve root retraction Additionally in revision cases where scar tissue hinders identification of neural structures avoidance of midline scar planes with the TLIF procedure is beneficial Moreover a circumferential fusion can be achieved from a unilateral approach with the TLIF procedure without having to expose the bilateral epidural space Karikari Isaac O MD Isaacs Robert E MD 2010
Technological advances better magnification and illumination modern tubular retractors and percutaneous screw systems and more frequent exposure of surgeons to minimally access surgery in their residency training has greatly contributed to the global success of minimal invasive transforaminal lumbar interbody fusion MI-TLIF Traditional open spinal fusion surgeries while effective are associated with considerable tissue disruption prolonged recovery times and higher risks of complicationsPrabhu et al 2022
MI-TLIFis one such advanced surgical technique designed to treat degenerative conditions of lumbar and lumbosacral spine diseases Through the tubular expander MIS-TLIF can reach the facet joints of the diseased segments MIS-TLIF effectively reduces the peeling and traction injury of the multifidus muscle prevents postoperative muscle atrophy and reduces the occurrence of postoperative chronic LBPSaela et al 2023
The MI-TLIF has shown reduced complications decreased intraoperative blood loss shorter hospital stays and recovery time and decreased postoperative narcotic usage while maintaining similar clinical outcomes and fusion rates to conventional open TLIF since its inception Hong et al 2022
The success of MI-TLIF can be attributed to the following fundamental principles 1 minimizing damage to soft tissues and avoiding destabilization of the spinal segments to achieve the surgical goal with the smallest possible operative footprint 2 utilizing a unilateral approach to achieve bilateral decompression when needed and 3 achieving neural decompression indirectly Although there is no definitive definition of MI-TLIF the lack of a precise definition has led to significant variations in how surgeons perform the procedure due to various technical nuances associated with each stepLener et al 2020
The use of minimally invasive surgical techniques represents the most recent modification of methods used to achieve lumbar interbody fusion based upon the premise that a smaller less traumatic incision should afford better recovery and outcomesJang et al 2024Hence in our study we aim to evaluate MI-TLIF for degenerative lumbar and lumbosacral spine diseases
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