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NCT Number: NCT06756984

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

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.

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Key information

Conditions

Sacral Tarlov Cysts Chronic Pain Related to Sacral Cysts Cysts Neoplasms Nervous System Diseases Neurological Dysfunction Associated With Tarlov Cysts Neuromuscular Diseases Peripheral Nervous System Diseases Symptomatic Sacral Cysts Tarlov Cysts

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Partial Cyst Wall Resection with Nerve Root Sleeve Plasty

Procedure

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.

Partial Cyst Wall Resection with Nerve Root Sleeve Reinforcement and Reconstruction:

Procedure

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.

Autologous Fat/Muscle with Fibrin Glue Microscopic Cyst Filling

Procedure

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 outcomes

  1. Pain Reduction Assessed by Visual Analog Scale (VAS)

    Time frame: Baseline, 1 month, 3 months, 6 months, 12 months and 24 months postoperatively

  2. 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 outcomes

  1. Recurrence Rate of Sacral Tarlov Cysts

    Time frame: 12 months postoperatively and annually up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Longqi Liu

CONTACT

[email protected]

010-15810072061

Sponsors and collaborators

Lead sponsor

Beijing Jishuitan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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