Clinical trial NCT06756984: Long-Term Outcomes of Different Surgical Techniques for Sacral Tarlov Cysts: A Prospective Cohort Study
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sacral Tarlov Cysts
Symptomatic Sacral Cysts
Chronic Pain Related to Sacral Cysts
Neurological Dysfunction Associated With Tarlov Cysts
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes adult patients aged 18-75 years diagnosed with symptomatic sacral Tarlov cysts, recruited from the Department of Neurosurgery at Beijing Jishuitan Hospital. Participants must exhibit persistent symptoms such as sacral or lower back pain, neurological deficits (e.g., numbness or weakness in the lower extremities), or bowel/bladder/sexual dysfunction attributable to the cyst, confirmed by MRI. The study focuses on individuals eligible for surgical intervention without significant comorbidities or prior related surgeries. This population represents a clinically relevant cohort for evaluating the efficacy and safety of different surgical techniques for sacral Tarlov cysts.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria

1. Age 18-75 years.
2. Diagnosed with symptomatic sacral Tarlov cysts confirmed by MRI.
3. 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.
4. Eligible for surgical intervention based on clinical evaluation.
5. Willing and able to provide written informed consent.

Exclusion Criteria

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

Primary outcomes:
measure: Pain Reduction Assessed by Visual Analog Scale (VAS)
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months and 24 months postoperatively
measure: Neurological Function Improvement Assessed by Japanese Orthopedic Association (JOA) Score
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months and 24 months postoperatively
Secondary outcomes:
measure: Recurrence Rate of Sacral Tarlov Cysts
timeFrame: 12 months postoperatively and annually up to 2 years
Other outcomes:
Locations:
Study officials:
References: