Study on Pathogenesis and Treatment of Sacral Tarlov Cysts
NCT ID: NCT05059275
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2020-09-03
2023-03-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomized Controlled Study on the Treatment of Sacral Canal Cysts With Sacral Canal Reinforcement
NCT04465305
Long-Term Outcomes of Different Surgical Techniques for Sacral Tarlov Cysts: A Prospective Cohort Study
NCT06756984
Case Report of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canal Plasty for the Treatment of Sacral Canal
NCT04960462
Study on Surgical Treatment of Pilonidal Sinus Disease
NCT02849197
Management of Coccydynia: A Prospective, Observational Study of Coccygectomy
NCT02701192
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
2. Modified microsurgical method is used to treat patients who met the inclusion criteria. To evaluate the surgical effect, we record and statistically compare the patients'outcomes before surgery and at the postoperative follow-up, which include the following: 1) Demographic data: sex, age, height, weight, body mass index (BMI), etc.; 2) clinical manifestations: symptoms and their features, complications, and long-term recovery; 3) Imaging findings: maximum diameter, location, shape, number, intracapsular nerve root condition, and postoperative outcome of TCs. 4) Surgical characteristics: operative process and time, intraoperative blood loss, assistive technologies, etc.; 5) Neurologic assessment using the following tools: The visual analogue scale (VAS), Scoring System for the Clinical Evaluation of Patients with Spinal Processes (hereinafter referred to as SCPS), Oswestry Disability Index (ODI), Japanese Orthopedic Association Scores 29 (JOA), and modified evaluation criteria for the efficacy of lumbar function (MacNab).All patients are required to return for MRI review and neurofunctional assessment at 3 and 12 months postoperatively, followed by annual examinations thereafter.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Modified operation group
Undergo the modified ostium obstruction surgery due to symptomatic TCs.
modified ostium obstruction surgery
An ostium at the end of the site where the nerve root enters the dural sac, from which CSF could flow continuously along the subarachnoid space, was identified An appropriate amount of autologous soft adipose tissue was removed under the skin of the incision or deep in the upper part of the buttock (Iliac spine incision, for less subcutaneous fat patients). It was then trimmed to resemble a gourd or dumbbell, with a relatively small middle section and two relatively large end sections. Trimmed graft was inserted into the neck of the sac and subarachnoid space below the dural sac so that it plugs the ostium inside and outside After filling the graft, Prolene 6-0 was used to continuously suture and close the ostium and dural sac starting from the lower part of the nerve root sheath and the ostium.The residual cyst cavity filled with autologous fat and gelatin sponge
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
modified ostium obstruction surgery
An ostium at the end of the site where the nerve root enters the dural sac, from which CSF could flow continuously along the subarachnoid space, was identified An appropriate amount of autologous soft adipose tissue was removed under the skin of the incision or deep in the upper part of the buttock (Iliac spine incision, for less subcutaneous fat patients). It was then trimmed to resemble a gourd or dumbbell, with a relatively small middle section and two relatively large end sections. Trimmed graft was inserted into the neck of the sac and subarachnoid space below the dural sac so that it plugs the ostium inside and outside After filling the graft, Prolene 6-0 was used to continuously suture and close the ostium and dural sac starting from the lower part of the nerve root sheath and the ostium.The residual cyst cavity filled with autologous fat and gelatin sponge
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Undergo regular review and long-term clinical effect evaluation;
* Agree to participate in this study.
Exclusion Criteria
* Failure to cooperate with follow-up work or lost to follow-up;
* Did not agree to participate in the study.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Southern Medical University, China
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yuntao Lu
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sharma M, SirDeshpande P, Ugiliweneza B, Dietz N, Boakye M. A systematic comparative outcome analysis of surgical versus percutaneous techniques in the management of symptomatic sacral perineural (Tarlov) cysts: a meta-analysis. J Neurosurg Spine. 2019 Feb 8;30(5):623-634. doi: 10.3171/2018.10.SPINE18952. Print 2019 May 1.
Singh PK, Singh VK, Azam A, Gupta S. Tarlov cyst and infertility. J Spinal Cord Med. 2009;32(2):191-7. doi: 10.1080/10790268.2009.11760771.
Fletcher-Sandersjoo A, Mirza S, Burstrom G, Pedersen K, Kuntze Soderqvist A, Grane P, Fagerlund M, Edstrom E, Elmi-Terander A. Management of perineural (Tarlov) cysts: a population-based cohort study and algorithm for the selection of surgical candidates. Acta Neurochir (Wien). 2019 Sep;161(9):1909-1915. doi: 10.1007/s00701-019-04000-5. Epub 2019 Jul 3.
Liu B, Wang Z, Lin G, Zhang J. Radiculoplasty with reconstruction using 3D-printed artificial dura mater for the treatment of symptomatic sacral canal cysts: Two case reports. Medicine (Baltimore). 2018 Dec;97(49):e13289. doi: 10.1097/MD.0000000000013289.
Guo D, Shu K, Chen R, Ke C, Zhu Y, Lei T. Microsurgical treatment of symptomatic sacral perineurial cysts. Neurosurgery. 2007 Jun;60(6):1059-65; discussion 1065-6. doi: 10.1227/01.NEU.0000255457.12978.78.
ABBOTT KH, LEIMBACH WH, RETTER RH. The role of perineurial sacral cysts in the sciatic and sacrococcygeal syndromes; a review of the literature and report of 9 cases. J Neurosurg. 1957 Jan;14(1):5-21. doi: 10.3171/jns.1957.14.1.0005. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SMU-Neurosurgery-spine
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.