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

Lumbar Disc Herniation Clinical Trial

Official title:

Collagenase Chemonucleolysis vs Percutaneous Endoscopic Lumbar Discectomy (PELD) for Lumbar Disc Herniation, a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05330806
• Other study ID #: ShenzhenPH spine wang05
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: June 28, 2023

Study information

• Verified date: March 2023
• Source: Shenzhen People's Hospital
• Contact: Hongyu Wang, Doctor
• Phone: 18241651300
• Email: wanghongyu790039663[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 28, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Procedure:
• Collagenase chemonucleolysis
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.
• Percutaneous endoscopic lumbar discectomy (PELD)
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.

Locations

Country	Name	City	State
China	ShenzhenPH	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Gadjradj PS, Harhangi BS. Percutaneous Transforaminal Endoscopic Discectomy for Lumbar Disk Herniation. Clin Spine Surg. 2016 Nov;29(9):368-371. doi: 10.1097/BSD.0000000000000366. — View Citation

Gibson JN, Cowie JG, Iprenburg M. Transforaminal endoscopic spinal surgery: the future 'gold standard' for discectomy? - A review. Surgeon. 2012 Oct;10(5):290-6. doi: 10.1016/j.surge.2012.05.001. Epub 2012 Jun 15. — View Citation

Yuan P, Shi X, Wei X, Wang Z, Mu J, Zhang H. Development process and clinical application of collagenase chemonucleolysis in the treatment of lumbar disc herniation: a narrative review in China. Postgrad Med J. 2022 Mar 14:postgradmedj-2021-141208. doi: 10.1136/postgradmedj-2021-141208. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale/Score of leg	Visual Analogue Scale pain assess for leg. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.	up to 12 months
Primary	Visual Analogue Scale/Score of lumbar	Visual Analogue Scale pain assess for lumbar. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.	up to 12 months
Primary	Recurrence rate	The percentage of disc herniation recurrence appearance. 0 represents the minimum and 100% represents the maximum.	up to 12 months
Primary	reoperation	The percentage of reoperation rate. 0 represents the minimum and 100% represents the maximum.	up to 12 months
Secondary	The Roland-Morris Disability Questionnaire	The Roland-Morris Disability Questionnaire is a health status measure designed to be completed by patients to assess physical disability due to low back pain. The lowest score is 0, the highest 24. The higher the score, the more severe the dysfunction.	up to 12 month
Secondary	the EuroQoL-5D (EQ-5D)	EQ-5D descriptive system is a preference-based Health-related quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. From this, a quality of life score can be calculated ranging from -0.594, indicating a health state worse than death where 0 is death, to 1, indicating full health	up to 12 month
Secondary	Duration of operation	Duration of operation time: The minimum value is 1 minute, and the maximum value is 120 minutes	up to 12 month
Secondary	Length of stay in the hospital	Length of stay in the hospital: The minimum value is 1 day. The maximum value is 30 days	up to 12 month
Secondary	Major complications	Major complications includes cerebrospinal fluid leakage,deep venous thrombosis in the leg, transient increase in neurological deficit, repeated surgery,Opioid analgesics	up to 12 month
Secondary	hospital fees	hospital fees :Minimum 500 yuan, maximum 30,000 yuan	up to 12 month
Secondary	the Oswestry Disability Index (ODI)	Disability was evaluated using the Oswestry Disability Index (ODI)	up to 12 month
Secondary	the Medical Outcomes Study 12-item short-form health survey (SF-12) scale	SF-12 including mental and physical components, was shorter versions of 36-item Short-Form Health Survey (SF-36) to evaluate life quality	up to 12 month
Secondary	modified MacNab	modified MacNab criteria is patient satisfaction with excellent outcomes, good, fair, and poor.	up to 12 month
Secondary	cost-effectiveness	Incremental cost-effectiveness ratios (ICERs) will be calculated by dividing the difference in costs by the difference in effects.	up to 12 month