Collagenase Chemonucleolysis vs Percutaneous Endoscopic Lumbar Discectomy (PELD) for Lumbar Disc Herniation

Southern University of Science and Technology

Status: Enrolling

Conditions: Lumbar Disc Herniation

Treatments: Procedure: Percutaneous endoscopic lumbar discectomy (PELD); Procedure: Collagenase chemonucleolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT05330806

ShenzhenPH spine wang05

Details and patient eligibility

About

Lumbar disc herniation compressed the nerve cause pain, numbness, weak legs called sciatica, which seriously decrease the quality of life and work efficiency. Both collagenase chemonucleolysis(CCNL) and percutaneous endoscopic lumbar discectomy (PELD) was effective to treat lumbar disc herniation(LDH) requires surgery. whether functional clinical outcomes of CCNL vs PELD effect on LDH was superior, and no study provided convincing evidence.

Full description

Lumbar disc herniation (LDH) is a common disease with an incidence of 1%-3%, usually manifested as low back pain radiating to the lower extremities, which seriously affects patients' quality of life. Collagen hydrolysis was effective in treating LDH, it makes the protrusion smaller or disappeared, relieving or resolving the compression of nerve root by the protrusion.Percutaneous endoscopic lumbar discectomy (PELD) is a less invasive techniques to treat LDH. However, the outcomes of collagen hydrolysis vs PELD effect was still unknown.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• at least six weeks of excessive radiating leg pain with no tendency for any clinical improvement despite conservative therapy
• have a nerve root compression by a lumbar disc herniation proven by magnetic resonance imaging

Exclusion criteria

• previous surgery at the same or adjacent disc level;
• isthmic or degenerative spondylolisthesis
• pregnancy
• severe comorbid medical or psychiatric disorder (American Society of Anesthesiologists' classification >2);
• severe caudal or cranial sequestration of disc fragments, defined as sequestration towards more than half of the adjacent vertebra;
• contraindication for surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

Collagenase chemonucleolysis

Experimental group

Description:

After local anesthesia, and the puncture point was 8-12cm on the side of the paraspinous process under C arm fluoroscopy. The needle was punctured though the skin with an angle of 45-60 to the posterior of the vertebral via "safe" entry zone to the herniated site outside the intervertebral disc under the epidural space. The syringe was drawn back to confirm that no blood or cerebrospinal fluid was flowing out, Contrast agents were injected to make sure no flows out of the spinal canal. 600 unit collagenase was dissolved in 2ml normal saline and injected slowly with rate of 1ml per minute. The needle was removed and keep the dorsal elevated position for 6-8 hours. Keep away from load bear of lumbar for 3 months.

Treatment:

Procedure: Collagenase chemonucleolysis

Percutaneous endoscopic lumbar discectomy (PELD)

Active Comparator group

Description:

For L1-L4 segment, percutaneous endoscopic transforaminal discectomy(PETD) will be performed. An 1cm length incision was made at 8-14cm lateral of the paraspinous process, where a needle puncture to the superior articular process of the lower involved vertebrae of the herniated disc. A series of conical rods are to be introduced, subsequently a reamer is to be introduced through the cannula. After removal of the disc herniation, the cannula and endoscope are to be removed. For L5/S1 segment, percutaneous endoscopic interlaminar discectomy(PEID) was performed. An incision of nearly 7 mm was made at the entry point of the skin, and a series of expansion channels were sequentially inserted into the surface of the ligamentum flavum.Then, the ligamentum flavum and soft tissue around it were removed. Then, the tongue of the working cannula was inserted and rotated into the lateral nerve root. Removed the prominent nucleus pulposus by various nucleus pulposus forceps.

Treatment:

Procedure: Percutaneous endoscopic lumbar discectomy (PELD)