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Not yet recruiting NCT06756984

Long-Term Outcomes of Different Surgical Techniques for Sacral Tarlov Cysts: A Prospective Cohort Study

— Observational Sacral Tarlov Cysts Symptomatic Sacral Cysts Chronic Pain Related to Sacral Cysts Neurological Dysfunction Associated With Tarlov Cysts

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Partial Cyst Wall Resection with Nerve Root Sleeve Plasty, Partial Cyst Wall Resection with Nerve Root Sleeve Reinforcement and Reconstruction:, Autologous Fat/Muscle with Fibrin Glue Microscopic Cyst Filling.
Who it may be relevant to
Registry conditions: Sacral Tarlov Cysts, Symptomatic Sacral Cysts, Chronic Pain Related to Sacral Cysts, Neurological Dysfunction Associated With Tarlov Cysts. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Prospective Cohort Study on the Long-Term Outcomes and Prognostic Factors of Different Surgical Techniques for the Treatment of Sacral Tarlov Cysts

Overview

Brief Summary The goal of this observational study is to evaluate the long-term outcomes of different surgical techniques for sacral Tarlov cysts in adult patients aged 18-75 years diagnosed with symptomatic sacral Tarlov cysts. The main questions it aims to answer are: * Does one surgical technique result in better pain relief (measured by VAS score) and functional recovery (measured by JOA score) compared to others? * How do different surgical techniques impact the long-term recurrence rate and complication rate? Researchers will compare three surgical techniques: 1. Partial cyst wall resection with nerve root sleeve plasty. 2. Partial cyst wall resection with nerve root sleeve reinforcement and reconstruction. 3. Autologous fat/muscle with fibrin glue microscopic cyst filling. Participants will: * Undergo one of the three surgical procedures based on clinical indications. * Complete preoperative and postoperative assessments, including pain and functional scoring, as well as MRI evaluations at baseline and during follow-up. * Participate in a follow-up program for up to 2 years to monitor outcomes and recurrence.

Interventions

  • Procedure Partial Cyst Wall Resection with Nerve Root Sleeve Plasty
    Surgical technique involving partial removal of the cyst wall to decompress the nerve root, followed by plasty of the nerve root sleeve to restore nerve function and prevent recurrence.
  • Procedure Partial Cyst Wall Resection with Nerve Root Sleeve Reinforcement and Reconstruction:
    Advanced surgical technique combining partial cyst wall removal with additional reinforcement and reconstruction of the nerve root sleeve to provide enhanced support and reduce the risk of cyst recurrence.
  • Procedure Autologous Fat/Muscle with Fibrin Glue Microscopic Cyst Filling
    Minimally invasive surgical technique where autologous fat or muscle tissue is used to fill the cyst cavity, and fibrin glue is applied to seal the defect, aiming to obliterate the cyst and prevent cerebrospinal fluid leakage.

Primary outcome measures

  • Pain Reduction Assessed by Visual Analog Scale (VAS) [Time frame: Baseline, 1 month, 3 months, 6 months, 12 months and 24 months postoperatively]
  • Neurological Function Improvement Assessed by Japanese Orthopedic Association (JOA) Score [Time frame: Baseline, 1 month, 3 months, 6 months, 12 months and 24 months postoperatively]
Secondary outcome measures (1)
  • Recurrence Rate of Sacral Tarlov Cysts [Time frame: 12 months postoperatively and annually up to 2 years]

Eligibility criteria

Inclusion criteria

  • Age 18-75 years.
  • Diagnosed with symptomatic sacral Tarlov cysts confirmed by MRI.
  • Presence of at least one of the following symptoms:
  • Persistent sacral or lower back pain (VAS score ≥ 4).
  • Neurological deficits such as lower extremity numbness or weakness.
  • Bowel, bladder, or sexual dysfunction attributable to the cyst.
  • Eligible for surgical intervention based on clinical evaluation.
  • Willing and able to provide written informed consent.

Exclusion criteria

  • History of prior sacral Tarlov cyst surgery.
  • Concurrent spinal conditions requiring separate surgical intervention.
  • Active infection or systemic inflammatory disease.
  • Severe comorbidities that increase surgical risk (e.g., advanced cardiac or pulmonary disease).
  • Pregnancy or lactation.
  • Inability to comply with follow-up requirements.
  • Known allergy or contraindication to surgical materials (e.g., fibrin glue).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06756984 · STC_2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗