An Effect and Safety Observation on PELD Technique for Extraforaminal Disc Herniation at L5/S1

NCT ID: NCT03511456

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-05
• Study Completion Date: 2022-03-05

Brief Summary

43% or so of far lateral lumbar disc herniation (FLLDH) occurred at L5/S1, however, the surgical treatment is still quite challenging. We conducted a modified PELD technique that enable us to remove the extraforaminal herniated disc at L5/S1, through the anatomical space surrounded by transverse process, facet joint and sacrum (TFS space). This study is to this technique's effect and safety in a one year follow-up.

Detailed Description

30 cases diagnosed as extraforaminal disc herniation at the segment of Lumbar 5 / sacrum 1 (L5/S1) will be recruited in this investigation. All the patients will receive PELD operation following the strict procedure that penetrating through the TFS space. The pain score (VAS), physical ability (ODI score) and life quality (SF-36） will be evaluated one day before surgery and 2 days, 1 month and 3 months after the surgery. Any side effects such as infection, nerve damage, main blood vessel injury will be recorded.

The operation procedure must follow the following steps:

1. The patient was positioned prone.

2. The skin entry point was determined using axial MRI or CT images

3. During operation, with anterior posterior view of fluoroscopy, the longitudinal midline of lumbar spine on the skin (Line C), the line right across L5/S1 space (Line A) was marked on the skin. With lateral view, the line right across L5/S1 space was also marked on skin (Line B). The line A and B should be crossed. The final entry point on skin was on the Line A and away from midline with the distance measured on axial MRI or CT images as described above.

4. Local infiltration with 1% Lidocaine was applied to skin and deep fascia on the penetration path. The introduction of long 20G needles could be performed with continuous or intermittent fluoroscopy. The needle traveled through TFS space. Generally, the position just above S1 superior endplate has enough safe space from the existing nerve root that might be pushed downward by the protruded discs, so it is usually the target for needle puncture.

Discography was strongly recommended to confirm diagnosis and distinguish the protruded disc from the surrounding soft tissue.

5. The following steps were performed as usual: the needle was replaced by a guide wire; a 9 mm incision was made in the skin at the entry site; a tapered cannulated dilator was inserted along the guide wire; and finally a beveled round working cannula of 8.0 mm in outer diameter was inserted, with the beveled tip touching the endplate of S1 and leaning against superior articular process of S1. If the TFS space is not big enough for working cannula, manual bone drills with blunt tip could be used to enlarge it.

Soft tissue including fat tissue, muscle and fibers of ligaments were pushed cephalad until the blue stained herniated disc was visible. Then the disc was removed. An absorbable gelatin sponge was impacted via the working cannula for hemostasis. A sterile dressing was applied with a one-point suture.

Conditions

Neuralgia, Sciatic

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

FLLDH-PELD

Extraforaminal LDH patients received PELD operation

PELD operation

Intervention Type: PROCEDURE

Under local anesthesia, the introduction of 20G needles could be performed with fluoroscopy. After the needle traveled through TFS space, extremely care was needed to avoid nerve root injury.

Discography was recommended. The following steps were performed as usual: the needle was replaced by a guide wire; a 9 mm incision was made in the skin; a tapered cannulated dilator was inserted along the guide wire; and finally a working cannula was inserted.

The remove of disc was performed carefully under endoscope. The first step was to locate the annulus fibrosis of L5/S1 disc, then by using nerve dissector and bipolar elliquence, soft tissue including fat tissue, muscle and fibers of ligaments were pushed cephalad until the blue stained herniated disc was visible and removed.

Interventions

PELD operation

Under local anesthesia, the introduction of 20G needles could be performed with fluoroscopy. After the needle traveled through TFS space, extremely care was needed to avoid nerve root injury.

Discography was recommended. The following steps were performed as usual: the needle was replaced by a guide wire; a 9 mm incision was made in the skin; a tapered cannulated dilator was inserted along the guide wire; and finally a working cannula was inserted.

The remove of disc was performed carefully under endoscope. The first step was to locate the annulus fibrosis of L5/S1 disc, then by using nerve dissector and bipolar elliquence, soft tissue including fat tissue, muscle and fibers of ligaments were pushed cephalad until the blue stained herniated disc was visible and removed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients suffered with extraforaminal lumbar disc herniation at L5/S1
• Patients received percutaneous endoscopic lumbar discectomy

Exclusion Criteria

• The diagnosis is not comply with the FLLDH
• patients not choose PELD operation
• patients unwilling to accept regular followup

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dehong Yang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dehong Yang, MD, PhD

Role: CONTACT

drmyang@yahoo.com

0118618620087638

Xiaoliang Wu, MD

Role: CONTACT

Kennymd@126.com

0118613226689489

Facility Contacts

Xiaoliang Wu, MD

Role: primary

Other Identifiers

NFEC-2018-022

Identifier Type: -

Identifier Source: org_study_id