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临床试验/NCT03511456
NCT03511456Unknown不适用

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

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年3月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Pain score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Pain score

时间窗: The change of leg/waist pain before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation).

Pain evaluated by Visual Analogue Scale system. Using a scale ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" and the "agonizing pain" according to the patient's mark, providing a range of scores from 0-10. A higher score means intensifier pain. The effects of operation is based on the different VAS scores evaluated by pre- or post- surgical patients who described their pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-1), mild pain(2-5), moderate pain (6-8 mm), and severe pain (9-10).

次要结局

  • Life quality(The change of life quality before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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