Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448416
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
Assessment of Unilateral Biportal Endoscopy Technique Applied to Treatment of Degenerative Lumbar Pathologies
Sponsor:
GCS Ramsay Santé pour lEnseignement et la Recherche
Organization:
GCS Ramsay Santé pour lEnseignement et la Recherche
Study Overview
Official Title:
Assessment of Unilateral Biportal Endoscopy Technique Applied to Treatment of Degenerative Lumbar Pathologies
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
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:
UBEVAL
Brief Summary:
Lumbar disc herniation HDL is one of the main causes for low back pain and sciatica Although non surgical care remains the gold standard as first treatment lumbar discectomy is used to effectively relieve symptoms that persist for prolonged periods
With surgical techniques evolution minimally invasive spine surgery has emerged in recent decades as an alternative to conventional open surgery and is widely used for HDL treatment Several minimally invasive surgical endoscopic techniques have been developed for disc herniation Single Portal Endoscopy SE Video Assisted Endoscopic Discectomy and recently Unilateral Biportal Endoscopy UBE
Currently SE is considered as the minimally invasive surgery gold standard for HDL but over the past two years UBE for the treatment of degenerative lumbar diseases has increased exponentially with faster learning curve than other endoscopic techniques
As an emerging technique further studies are needed to better understand UBE This is why Dr Cristinis team wish to analyze a cohort of patients for whom this technique has been used since July 2022 in particular the complication rate
Controlling a new technique requires a learning phase This is why Dr Cristinis team also wishes to describe the learning curve on the cohort of patients for whom UBE was used since July 2022
With surgical techniques evolution minimally invasive spine surgery has emerged in recent decades as an alternative to conventional open surgery and is widely used for HDL treatment Several minimally invasive surgical endoscopic techniques have been developed for disc herniation Single Portal Endoscopy SE Video Assisted Endoscopic Discectomy and recently Unilateral Biportal Endoscopy UBE
Currently SE is considered as the minimally invasive surgery gold standard for HDL but over the past two years UBE for the treatment of degenerative lumbar diseases has increased exponentially with faster learning curve than other endoscopic techniques
As an emerging technique further studies are needed to better understand UBE This is why Dr Cristinis team wish to analyze a cohort of patients for whom this technique has been used since July 2022 in particular the complication rate
Controlling a new technique requires a learning phase This is why Dr Cristinis team also wishes to describe the learning curve on the cohort of patients for whom UBE was used since July 2022
Detailed Description:
Lumbar disc herniation HDL is one of the main causes for low back pain and sciatica affecting 1 to 5 of the population each year Although non surgical care remains the gold standard as first treatment lumbar discectomy is used to effectively relieve symptoms that persist for prolonged periods
With surgical techniques evolution minimally invasive spine surgery has emerged in recent decades as an alternative to conventional open surgery and is widely used for HDL treatment Compared to traditional open surgery minimally invasive surgical technique offers muscle and bone sparing pain reduction and faster recovery allowing patient management in Enhanced Recovery After Surgery RAAC
Several minimally invasive surgical endoscopic techniques have been developed for disc herniation Single Portal Endoscopy SE Video Assisted Endoscopic Discectomy and recently Unilateral Biportal Endoscopy UBE SE relies on a single entry route whereas UBE is based on two entry routes one way for optical instruments and saline irrigation system and one way for surgical instruments Currently SE is considered as the minimally invasive surgery gold standard for HDL treatment thanks to its advantages for controlling muscles trauma reducing hospital stay and maintaining spinal segment stability
Over the past two years UBE for the treatment of degenerative lumbar diseases has increased exponentially with faster learning curve than other endoscopic techniques
UBE allows a wider field of vision wide and ergonomic operating gestures is minimally invasive and contributes to complete nervous decompression and faster recovery With UBE the surgeon can use one hand to guide endoscope and he other one to guide surgical instruments In addition UBE generates less trauma less bleeding rapid recovery and good effectiveness in HDL treatment UBE can significantly reduce postoperative nerve fibrosis and postoperative spinal instability incidence
During UBE some postoperative complications have been described as poor treatment effectiveness nucleus pulposus nucleus residue epidural hematoma dural tear nerve root injury and incomplete surgery
As an emerging technique further studies are needed to better understand UBE This is why Dr Cristinis team wish to analyze a cohort of patients for whom this technique has been used since July 2022 in particular the complication rate
Controlling a new technique requires a learning phase Chen L et al showed that the operation duration and the postoperative hospitalization duration were reduced from the 24th patient until the 97th patient out of a cohort of 97 patients with lumbar disc herniation treated by UBE However there was no significant difference in the visual analogue scale VAS and the Oswestry disability index ODI in all operated patients This indicates that UBE still guarantees clinical effect and safety on all operated patients This is why Dr Cristinis team also wishes to describe the learning curve on the cohort of patients for whom UBE was used since July 2022
With surgical techniques evolution minimally invasive spine surgery has emerged in recent decades as an alternative to conventional open surgery and is widely used for HDL treatment Compared to traditional open surgery minimally invasive surgical technique offers muscle and bone sparing pain reduction and faster recovery allowing patient management in Enhanced Recovery After Surgery RAAC
Several minimally invasive surgical endoscopic techniques have been developed for disc herniation Single Portal Endoscopy SE Video Assisted Endoscopic Discectomy and recently Unilateral Biportal Endoscopy UBE SE relies on a single entry route whereas UBE is based on two entry routes one way for optical instruments and saline irrigation system and one way for surgical instruments Currently SE is considered as the minimally invasive surgery gold standard for HDL treatment thanks to its advantages for controlling muscles trauma reducing hospital stay and maintaining spinal segment stability
Over the past two years UBE for the treatment of degenerative lumbar diseases has increased exponentially with faster learning curve than other endoscopic techniques
UBE allows a wider field of vision wide and ergonomic operating gestures is minimally invasive and contributes to complete nervous decompression and faster recovery With UBE the surgeon can use one hand to guide endoscope and he other one to guide surgical instruments In addition UBE generates less trauma less bleeding rapid recovery and good effectiveness in HDL treatment UBE can significantly reduce postoperative nerve fibrosis and postoperative spinal instability incidence
During UBE some postoperative complications have been described as poor treatment effectiveness nucleus pulposus nucleus residue epidural hematoma dural tear nerve root injury and incomplete surgery
As an emerging technique further studies are needed to better understand UBE This is why Dr Cristinis team wish to analyze a cohort of patients for whom this technique has been used since July 2022 in particular the complication rate
Controlling a new technique requires a learning phase Chen L et al showed that the operation duration and the postoperative hospitalization duration were reduced from the 24th patient until the 97th patient out of a cohort of 97 patients with lumbar disc herniation treated by UBE However there was no significant difference in the visual analogue scale VAS and the Oswestry disability index ODI in all operated patients This indicates that UBE still guarantees clinical effect and safety on all operated patients This is why Dr Cristinis team also wishes to describe the learning curve on the cohort of patients for whom UBE was used since July 2022
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None