Clinical trial NCT05330806: Collagenase Chemonucleolysis vs Percutaneous Endoscopic Lumbar Discectomy (PELD) for Lumbar Disc Herniation
Official title: Collagenase Chemonucleolysis vs Percutaneous Endoscopic Lumbar Discectomy (PELD) for Lumbar Disc Herniation, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Disc Herniation
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale/Score of leg
timeFrame: up to 12 months
measure: Visual Analogue Scale/Score of lumbar
timeFrame: up to 12 months
measure: Recurrence rate
timeFrame: up to 12 months
measure: reoperation
timeFrame: up to 12 months
Secondary outcomes:
measure: The Roland-Morris Disability Questionnaire
timeFrame: up to 12 month
measure: the EuroQoL-5D (EQ-5D)
timeFrame: up to 12 month
measure: Duration of operation
timeFrame: up to 12 month
measure: Length of stay in the hospital
timeFrame: up to 12 month
measure: Major complications
timeFrame: up to 12 month
measure: hospital fees
timeFrame: up to 12 month
measure: the Oswestry Disability Index (ODI)
timeFrame: up to 12 month
measure: the Medical Outcomes Study 12-item short-form health survey (SF-12) scale
timeFrame: up to 12 month
measure: modified MacNab
timeFrame: up to 12 month
measure: cost-effectiveness
timeFrame: up to 12 month
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: ShenzhenPH
state: Guangdong
Study officials:
affiliation: Shenzhen People's Hospital
name: Songlin Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.