NCT05330806

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

2.4 years

First QC Date

March 24, 2022

Last Update Submit

March 9, 2023

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Recurrence rate

    The percentage of disc herniation recurrence appearance. 0 represents the minimum and 100% represents the maximum.

    up to 12 months

  • reoperation

    The percentage of reoperation rate. 0 represents the minimum and 100% represents the maximum.

    up to 12 months

Secondary Outcomes (10)

  • The Roland-Morris Disability Questionnaire

    up to 12 month

  • the EuroQoL-5D (EQ-5D)

    up to 12 month

  • Duration of operation

    up to 12 month

  • Length of stay in the hospital

    up to 12 month

  • Major complications

    up to 12 month

  • +5 more secondary outcomes

Study Arms (2)

Collagenase chemonucleolysis

EXPERIMENTAL

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.

Procedure: Collagenase chemonucleolysis

Percutaneous endoscopic lumbar discectomy (PELD)

ACTIVE COMPARATOR

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.

Procedure: Percutaneous endoscopic lumbar discectomy (PELD)

Interventions

Collagenase chemonucleolysisPROCEDURE

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.

Collagenase chemonucleolysis
Percutaneous endoscopic lumbar discectomy (PELD)PROCEDURE

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.

Also known as: Percutaneous transforaminal endoscopic discectomy (PTED) for L1-L4 and percutaneous endoscopic interlaminar discectomy(PEID) for L5-S1 lumbar disc herniation
Percutaneous endoscopic lumbar discectomy (PELD)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ShenzhenPH

Shenzhen, Guangdong, 518000, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 22705355BACKGROUND

  • 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.

    PMID: 35288448BACKGROUND

  • 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.

    PMID: 26945128BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Songlin Peng, Doctor

    Shenzhen People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongyu Wang, Doctor

CONTACT

18241651300wanghongyu790039663@126.com

Ziming Zhao, Master

CONTACT

18841609587zhzm622@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2022

First Posted

April 15, 2022

Study Start

January 15, 2021

Primary Completion

June 25, 2023

Study Completion

June 28, 2023

Last Updated

March 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)