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A Randomized Controlled Study on the Treatment of Sacral Canal Cysts With Sacral Canal Reinforcement (ARCSTSCC)

Primary Purpose

Tarlov Cysts

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
entraped treatment
plasty treatment
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tarlov Cysts focused on measuring tarlov cysts surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Symptomatic nerve root cysts diagnosed by MRI
  2. Intact cyst capsule, no defect of sacral canal lamina
  3. No other diseases of nervous system, pelvic floor and important organs
  4. Agree inclusion

Exclusion Criteria:

a ) Non-radiculent cysts or asymptomatic cysts b) Cysts cause severe bone erosion to lamina resorption c) Combined with other diseases of nervous system, pelvic floor and important organs d) Disagree to join e) Cannot complete follow-up -

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

enraped group

plasty group

Arm Description

patients with a new treatment of tarlov cysts

patients with traditional treatment of tarlov cysts

Outcomes

Primary Outcome Measures

recurrent rate of tarlov cysts
patents who recurrent postoperation

Secondary Outcome Measures

Full Information

First Posted
July 6, 2020
Last Updated
July 4, 2021
Sponsor
Peking University Third Hospital
Collaborators
Beijing Municipal Science & Technology Commission
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1. Study Identification

Unique Protocol Identification Number
NCT04465305
Brief Title
A Randomized Controlled Study on the Treatment of Sacral Canal Cysts With Sacral Canal Reinforcement
Acronym
ARCSTSCC
Official Title
A Randomized Controlled Study of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canopy for the Treatment of Sacral Canal Cysts
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Beijing Municipal Science & Technology Commission

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
The subject will treat 68 patients with symptomatic sacral canal cysts as the research object, and adopt a randomized controlled research method, respectively, using two methods of reinforcement and reconstruction of the nerve root sleeve, sacroplasty and nerve root sleeve plasty, and observed the operation of the patient Complications, preoperative and postoperative short-term and long-term VAS pain scores, JOA neural function scores, and changes in cyst size on imaging examinations, to evaluate the safety of nerve root sleeve reconstruction and sacroplasty in reducing the safety of postoperative cyst recurrence Sex and effectiveness, so as to further improve the surgical treatment of sacral canal cysts, improve the curative effect, and formulate the operation specifications for the treatment of sacral canal cyst
Detailed Description
In this subject, a cohort observation method was used to observe 52 patients with two types of surgical removal of hematoma in the basal ganglia under the guidance of frontal ultrasound through keyhole neuroendoscopy and microsurgery for hematoma removal under the guidance of frontal ultrasound. They were divided into endoscopic surgery group and microsurgery. In the endoscopic surgery group, 26 cases were treated with keyhole neuroendoscopy under the guidance of frontal ultrasound for hematoma removal in the basal ganglia area, and 26 cases in the microsurgery group were treated by craniotomy microsurgery hematoma removal surgery. Observe the removal rate of surgical hematoma in the two groups And the safety of the operation and the GCS score, GOS score and MRI examination of nerve fiber damage and postoperative complications at 1 week, 1 month, and 3 months after the operation. Observe and analyze the improvement of the hematoma clearance rate in the endoscopic surgery group. And whether it has an advantage in terms of efficacy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tarlov Cysts
Keywords
tarlov cysts surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
enraped group
Arm Type
Experimental
Arm Description
patients with a new treatment of tarlov cysts
Arm Title
plasty group
Arm Type
Active Comparator
Arm Description
patients with traditional treatment of tarlov cysts
Intervention Type
Procedure
Intervention Name(s)
entraped treatment
Other Intervention Name(s)
plasty treatment
Intervention Description
patients with tarlov cysts treated by entraped and plasty nerve root
Intervention Type
Procedure
Intervention Name(s)
plasty treatment
Intervention Description
patients with tarlov cysts treated by plasty nerve root
Primary Outcome Measure Information:
Title
recurrent rate of tarlov cysts
Description
patents who recurrent postoperation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic nerve root cysts diagnosed by MRI Intact cyst capsule, no defect of sacral canal lamina No other diseases of nervous system, pelvic floor and important organs Agree inclusion Exclusion Criteria: a ) Non-radiculent cysts or asymptomatic cysts b) Cysts cause severe bone erosion to lamina resorption c) Combined with other diseases of nervous system, pelvic floor and important organs d) Disagree to join e) Cannot complete follow-up -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
liu bin
Phone
13671027688
Email
liubin301@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
wu chao
Phone
82267358
Ext
086010
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
liu bin
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
wang zhenyu
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
xie jinchen
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Peking
State/Province
Haidian
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
liu bin
Phone
13671027688
Email
liubin301@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Randomized Controlled Study on the Treatment of Sacral Canal Cysts With Sacral Canal Reinforcement

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