Back to resultsCollagenase Chemonucleolysis vs Percutaneous Endoscopic Lumbar Discectomy (PELD) for Lumbar Disc Herniation
Primary Purpose
Lumbar Disc Herniation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Collagenase chemonucleolysis
Percutaneous endoscopic lumbar discectomy (PELD)
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation
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
Sites / Locations
- ShenzhenPHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Collagenase chemonucleolysis
Percutaneous endoscopic lumbar discectomy (PELD)
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Recurrence rate
The percentage of disc herniation recurrence appearance. 0 represents the minimum and 100% represents the maximum.
reoperation
The percentage of reoperation rate. 0 represents the minimum and 100% represents the maximum.
Secondary Outcome Measures
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.
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
Duration of operation
Duration of operation time： The minimum value is 1 minute, and the maximum value is 120 minutes
Length of stay in the hospital
Length of stay in the hospital： The minimum value is 1 day. The maximum value is 30 days
Major complications
Major complications includes cerebrospinal fluid leakage,deep venous thrombosis in the leg, transient increase in neurological deficit, repeated surgery,Opioid analgesics
hospital fees
hospital fees ：Minimum 500 yuan, maximum 30,000 yuan
the Oswestry Disability Index (ODI)
Disability was evaluated using the Oswestry Disability Index (ODI)
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
modified MacNab
modified MacNab criteria is patient satisfaction with excellent outcomes, good, fair, and poor.
cost-effectiveness
Incremental cost-effectiveness ratios (ICERs) will be calculated by dividing the difference in costs by the difference in effects.
Full Information
NCT ID
NCT05330806
First Posted
March 24, 2022
Last Updated
March 9, 2023
Sponsor
Shenzhen People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05330806
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
June 25, 2023 (Anticipated)
Study Completion Date
June 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Collagenase chemonucleolysis
Arm Type
Experimental
Arm 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.
Arm Title
Percutaneous endoscopic lumbar discectomy (PELD)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Collagenase chemonucleolysis
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous endoscopic lumbar discectomy (PELD)
Other Intervention Name(s)
Percutaneous transforaminal endoscopic discectomy (PTED) for L1-L4 and percutaneous endoscopic interlaminar discectomy(PEID) for L5-S1 lumbar disc herniation
Intervention 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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale/Score of leg
Description
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.
Time Frame
up to 12 months
Title
Visual Analogue Scale/Score of lumbar
Description
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.
Time Frame
up to 12 months
Title
Recurrence rate
Description
The percentage of disc herniation recurrence appearance. 0 represents the minimum and 100% represents the maximum.
Time Frame
up to 12 months
Title
reoperation
Description
The percentage of reoperation rate. 0 represents the minimum and 100% represents the maximum.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
The Roland-Morris Disability Questionnaire
Description
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.
Time Frame
up to 12 month
Title
the EuroQoL-5D (EQ-5D)
Description
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
Time Frame
up to 12 month
Title
Duration of operation
Description
Duration of operation time： The minimum value is 1 minute, and the maximum value is 120 minutes
Time Frame
up to 12 month
Title
Length of stay in the hospital
Description
Length of stay in the hospital： The minimum value is 1 day. The maximum value is 30 days
Time Frame
up to 12 month
Title
Major complications
Description
Major complications includes cerebrospinal fluid leakage,deep venous thrombosis in the leg, transient increase in neurological deficit, repeated surgery,Opioid analgesics
Time Frame
up to 12 month
Title
hospital fees
Description
hospital fees ：Minimum 500 yuan, maximum 30,000 yuan
Time Frame
up to 12 month
Title
the Oswestry Disability Index (ODI)
Description
Disability was evaluated using the Oswestry Disability Index (ODI)
Time Frame
up to 12 month
Title
the Medical Outcomes Study 12-item short-form health survey (SF-12) scale
Description
SF-12 including mental and physical components, was shorter versions of 36-item Short-Form Health Survey (SF-36) to evaluate life quality
Time Frame
up to 12 month
Title
modified MacNab
Description
modified MacNab criteria is patient satisfaction with excellent outcomes, good, fair, and poor.
Time Frame
up to 12 month
Title
cost-effectiveness
Description
Incremental cost-effectiveness ratios (ICERs) will be calculated by dividing the difference in costs by the difference in effects.
Time Frame
up to 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongyu Wang, Doctor
Phone
18241651300
Email
wanghongyu790039663@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ziming Zhao, Master
Phone
18841609587
Email
zhzm622@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Songlin Peng, Doctor
Organizational Affiliation
Shenzhen People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ShenzhenPH
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyu Wang, Doctor
Phone
18241651300
Email
wanghongyu790039663@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22705355
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.
Results Reference
background
PubMed Identifier
35288448
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.
Results Reference
background
PubMed Identifier
26945128
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.
Results Reference
background
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Collagenase Chemonucleolysis vs Percutaneous Endoscopic Lumbar Discectomy (PELD) for Lumbar Disc Herniation
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