Sacral Tarlov CystsNCT06756984
Long-Term Outcomes of Different Surgical Techniques for Sacral Tarlov Cysts: A Prospective Cohort Study
An observational study of Sacral Tarlov Cysts and Symptomatic Sacral Cysts, run by Beijing Jishuitan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sacral Tarlov Cysts, Symptomatic Sacral Cysts, Chronic Pain Related to Sacral Cysts
- What is being tested?
- Partial Cyst Wall Resection with Nerve Root Sleeve Plasty, Partial Cyst Wall Resection with Nerve Root Sleeve Reinforcement and Reconstruction: and Autologous Fat/Muscle with Fibrin Glue Microscopic Cyst Filling
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 13 May 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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
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:
Read more
- 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:
- 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.
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.
- Conditions
- Sacral Tarlov Cysts, Symptomatic Sacral Cysts, Chronic Pain Related to Sacral Cysts, Neurological Dysfunction Associated With Tarlov Cysts
- Being tested
- 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
- Medical subject headings
- Tarlov Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Cyst Wall Resection with Nerve Root Sleeve PlastyProcedure or surgery
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 or surgery
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 FillingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Partial Cyst Wall Resection with Nerve Root Sleeve Plasty | Participants in this group will undergo partial resection of the cyst wall combined with nerve root sleeve plasty. This technique involves reducing the cyst size and reconstructing the nerve root sleeve to restore nerve function and reduce symptoms. Receives: Procedure: Partial Cyst Wall Resection with Nerve Root Sleeve Plasty | |
| Partial Cyst Wall Resection with Nerve Root Sleeve Reinforcement and Reconstruction | Participants in this group will undergo partial resection of the cyst wall along with reinforcement and reconstruction of the nerve root sleeve. This method provides additional structural stability to the nerve root and aims to reduce the risk of recurrence and improve postoperative outcomes. Receives: Procedure: Partial Cyst Wall Resection with Nerve Root Sleeve Reinforcement and Reconstruction: | |
| Autologous Fat/Muscle with Fibrin Glue Microscopic Cyst Filling | Participants in this group will receive autologous fat or muscle tissue filling of the cyst cavity combined with fibrin glue sealing under microscopic guidance. This technique aims to obliterate the cyst cavity, prevent cerebrospinal fluid leakage, and enhance symptom relief and recovery. Receives: Procedure: Autologous Fat/Muscle with Fibrin Glue Microscopic Cyst Filling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction Assessed by Visual Analog Scale (VAS)
Measured: Baseline, 1 month, 3 months, 6 months, 12 months and 24 months postoperatively
Neurological Function Improvement Assessed by Japanese Orthopedic Association (JOA) Score
Measured: Baseline, 1 month, 3 months, 6 months, 12 months and 24 months postoperatively
Secondary outcomes (1)
Recurrence Rate of Sacral Tarlov Cysts
Measured: 12 months postoperatively and annually up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start13 May 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacral Tarlov CystsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu longqi, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756984
- Sponsor's protocol ID
- STC_2025
- Status last verified
- May 2025
- First submitted
- 24 Dec 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06756984
- Acronym / sponsor ID
- STC_2025
- Conditions
- Sacral Tarlov Cysts, Symptomatic Sacral Cysts, Chronic Pain Related to Sacral Cysts, Neurological Dysfunction Associated With Tarlov Cysts
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 13 May 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Partial Cyst Wall Resection with Nerve Root Sleeve Plasty | – | Procedure: Partial Cyst Wall Resection with Nerve Root Sleeve PlastyParticipants in this group will undergo partial resection of the cyst wall combined with nerve root sleeve plasty. This technique involves reducing the cyst size and reconstructing the nerve root sleeve to restore nerve function and reduce symptoms. |
| Partial Cyst Wall Resection with Nerve Root Sleeve Reinforcement and Reconstruction | – | Procedure: Partial Cyst Wall Resection with Nerve Root Sleeve Reinforcement and Reconstruction:Participants in this group will undergo partial resection of the cyst wall along with reinforcement and reconstruction of the nerve root sleeve. This method provides additional structural stability to the nerve root and aims to reduce the risk of recurrence and improve postoperative outcomes. |
| Autologous Fat/Muscle with Fibrin Glue Microscopic Cyst Filling | – | Procedure: Autologous Fat/Muscle with Fibrin Glue Microscopic Cyst FillingParticipants in this group will receive autologous fat or muscle tissue filling of the cyst cavity combined with fibrin glue sealing under microscopic guidance. This technique aims to obliterate the cyst cavity, prevent cerebrospinal fluid leakage, and enhance symptom relief and recovery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Age 18-75 years.
- Diagnosed with symptomatic sacral Tarlov cysts confirmed by MRI.
- Presence of at least one of the following symptoms:
- Eligible for surgical intervention based on clinical evaluation.
- Willing and able to provide written informed consent.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial Cyst Wall Resection with Nerve Root Sleeve PlastySurgical 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 or surgery | Partial Cyst Wall Resection with Nerve Root Sleeve Plasty |
| 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 or surgery | Partial Cyst Wall Resection with Nerve Root Sleeve Reinforcement and Reconstruction |
| Autologous Fat/Muscle with Fibrin Glue Microscopic Cyst FillingMinimally 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. | Procedure or surgery | Autologous Fat/Muscle with Fibrin Glue Microscopic Cyst Filling |
Primary outcome
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
1 secondary outcome
Recurrence Rate of Sacral Tarlov Cysts
Time frame: 12 months postoperatively and annually up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacral Tarlov Cysts and Symptomatic Sacral Cysts, run by Beijing Jishuitan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Longqi Liu (010-15810072061, 15810072061@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Reduction Assessed by Visual Analog Scale (VAS) (time frame: Baseline, 1 month, 3 months, 6 months, 12 months and 24 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.