Clinical trial NCT03511456: An Effect and Safety Observation on PELD Technique for Extraforaminal Disc Herniation at L5/S1
Official title: An Effect and Safety Investigation on Percutaneous Endoscopic Lumbar Discectomy Technique to Remove Extraforaminal Disc Herniation at L5/S1 Segment Through 5th Transverse Process-facet Joint-sacrum Space
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuralgia, Sciatic
Keywords: leg pain
waist pain
life quality
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, diagnosed as extraforaminal lumbar disc herniation at L5/S1, and received the operation of percutaneous endoscopic lumbar discectomy

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.

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

Primary outcomes:
measure: Pain score
timeFrame: The change of leg/waist pain before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation).
Secondary outcomes:
measure: Life quality
timeFrame: The change of life quality before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation).
Other outcomes:
measure: Physical functional ability
timeFrame: The change of physical functional ability before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation).
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Dehong Yang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: