Disc Herniation Clinical Trial
Official title:
Assessment of Unilateral Biportal Endoscopy Technique Applied to Treatment of Degenerative Lumbar Pathologies
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. Cristini's 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. Cristini's team also wishes to describe the learning curve on the cohort of patients for whom UBE was used since July 2022.
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. Cristini's 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. Cristini's team also wishes to describe the learning curve on the cohort of patients for whom UBE was used since July 2022. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06006377 -
Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies
|
N/A | |
Terminated |
NCT01267825 -
CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial
|
Phase 4 | |
Active, not recruiting |
NCT06141551 -
Intradural Disc Herniation: a Case Report and Review of Complications
|
||
Recruiting |
NCT05732818 -
Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3
|
N/A | |
Recruiting |
NCT06023719 -
Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence
|
N/A | |
Enrolling by invitation |
NCT06415136 -
Adjacent Level Anterior Cervical Fusion: SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating
|
||
Completed |
NCT05687305 -
The Effect of White Noise in Patients Undergoing Lumbar Disc Herniation Surgery
|
N/A | |
Completed |
NCT05803954 -
Mobilization With Movement vs. Neural Mobilization on Nerve Root Function in Patients With Cervical Radiculopathy
|
N/A | |
Not yet recruiting |
NCT06275529 -
Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification
|
N/A | |
Completed |
NCT05680142 -
Regional Analgesia for Anterior Cervical Disc and Fusion Surgery
|
N/A | |
Not yet recruiting |
NCT05999565 -
Investigation of the Effect of Motor Imagery Training in Individuals With Cervical Discogenic Pain
|
N/A | |
Recruiting |
NCT05695014 -
Effect of Discharge Education on Discharge Readiness and Satisfaction
|
N/A | |
Completed |
NCT05753579 -
Is Regression Possible in Lumbal Disc Herniation With Spinal Mobilization Applications?
|
N/A | |
Recruiting |
NCT05306665 -
PREventing Pain After Surgery
|
N/A | |
Recruiting |
NCT06453499 -
Silent Lumbar Disc Herniation Syndrome
|
||
Not yet recruiting |
NCT06178939 -
Effects of Cognitive Intervention Therapy on Postoperative Delirium
|
N/A | |
Enrolling by invitation |
NCT05745129 -
Applying Artificial Intelligence in Developing Personalized and Sustainable Healthcare for Spinal Disorders
|
||
Recruiting |
NCT05808140 -
Fluorescence Imaging With Indocyanine Green(ICG) in Endoscopic Spinal Surgery
|
Phase 1/Phase 2 | |
Completed |
NCT06046781 -
Exercise After Lumbar Disc Herniation Surgery
|
N/A |