A Non-Inferiority Randomized Controlled Trial and Prospective Cohort Study Comparing Clinical Outcomes of Unilateral Biportal Endoscopic Surgery Utilizing the Interlaminar Approach Versus the Transforaminal Approach in Patients with Lumbar Disc Herniation

JRCT ID: jRCT1030240158

Registered date:13/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lumbar disc herniation
• Date of first enrollment: 03/06/2024
• Target sample size: 72
• Study type: Interventional

Intervention(s)

The two-portal endoscopic spine surgery (Unilateral Biportal Endoscopy:UBE) for lumbar disc herniation is a surgical method that is already being performed both domestically (Japan) and internationally. This study aims to verify the surgical outcomes based on the differences in the following two surgical approaches:
The InterLaminar Approach (ILA) involves inserting an endoscope posteriorly through the lumbar region to access the herniated lumbar disc via the interlaminar space.
The TransForaminal Approach (TFA) involves inserting an endoscope posterolaterally through the lumbar region to access the herniated lumbar disc via the foramen.

Outcome(s)

• Primary Outcome: Oswestry Disability Index (ODI) score 12 months post-surgery

Secondary Outcome

(1) NRS (Numerical Rating Scale) for surgical site pain assessed at 0, 1, 2, 4, 8, 12, and 24 hours post-operation, with an allowable margin of one hour before or after each specified time for evaluation.
(2) NRS for back pain at 2 weeks, 3 months, 6 months, and 12 months post-operation.
(3) NRS for leg pain and leg pain at 2 weeks, 3 months, 6 months, and 12 months post-operation.
(4) ODI (Oswestry Disability Index) scores at 3 and 6 months post-operation.
(5) QOL scores (EuroQol-5 Dimensions, Short Form-12) at 3, 6, and 12 months post-operation.
(6) Surgical-related outcomes including hospitalization costs, surgical duration, blood loss, and length of postoperative hospital stay.
(7) Perioperative complications including dural tear, reoperation due to postoperative hematoma, surgical site infection within one year, Creatine Phosphokinase ratio the day after surgery, and recurrence rate within one year.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Individuals who meet all of the following criteria are eligible:
(1) Those aged 18 to 80 years at the time of consent.
(2) Those diagnosed with lumbar disc herniation at a single spinal level, as confirmed by MRI.
(3) Those who have received conservative treatment for more than 6 weeks and present with radiculopathy symptoms rated at an NRS of 3 or higher at the time of consent.
(4) Those capable of providing written informed consent of their own free will.

Exclude criteria

The individuals who fall under any of the following categories are not eligible to participate:
(1) Those with a history of previous surgery at the same intervertebral level and on the same side (left or right).
(2) Those with significantly extruded hernias, as defined by the radiologic classification of migrated disc herniations into zone classification 1 or 4, as reported in 'Percutaneous Endoscopic Lumbar Discectomy for Migrated Disc Herniation: Classification of Disc Migration and Surgical Approaches,' Eur. Spine J., 2007, 16, pp. 431-437).
(3) Those with foraminal or far lateral hernias.
(4) Those with concurrent lumbar spinal stenosis.
(5) Those with lumbar spondylolisthesis of Meyerding grade 2 or more, or with spondylolysis.
(6) Those with lumbar scoliosis exhibiting a Cobb angle of 20 degrees or greater.
(7) Those with instability at the surgical level, defined as a lumbar functional X-ray in flexion and extension positions showing a slip of 3 mm or more.
(8) Those with reduced lower limb strength (Manual Muscle Test (MMT) grade 2 or lower, capable of movement throughout the range of motion when gravity is eliminated).
(9) Those with a history of fractures, tumors, or infections in the surgical level.
(10) Those who have undergone lumbar spine fusion surgery at any level, not limited to the intended surgical level.
(11) Those with a mental illness or a history thereof, who are poorly controlled in their treatment.
(12) Those whose distance from the skin to the target intervertebral disc exceeds the effective length of a standard bipolar radiofrequency system.
(13) Those who have difficulty understanding Japanese.
(14) Those who the research director (or delegate) deems inappropriate as study subjects.

Related Information

• Primary Sponsor: Segawa Tomohide