Tarlov CystsNCT04960462
Case Report of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canal Plasty for the Treatment of Sacral Canal
An observational study of Tarlov Cysts, run by Peking University Third Hospital at 1 site in China.
Trial summary
A retrospective study of the changes in the VAS scores and imaging examinations after the reconstruction and reinforcement of nerve root sleeves and caudal angioplasty for the treatment of sacral cysts from August 2017 to January 2018 was used to evaluate the efficacy of the surgical prescription. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tarlov Cysts
- What is being tested?
- nerve root sleeve reinforcement
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 30 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Clinical data (symptoms, signs, imaging findings) of patients with sacral cysts treated with sacral cyst reconstruction using nerve root sleeve reinforcement
Inclusion Criteria:a) Symptomatic nerve root cyst diagnosed by MRI b) The capsule of the cyst is intact and the sacral lamina is not defective c) No other diseases of the nervous system, pelvic floor and important organs d) Reconstruction of patients with artificial dural nerve root sleeve reinforcement -
Exclusion Criteria:a) Non-radiotomy cyst or asymptomatic cyst b) The cyst causes severe bone erosion to lamina absorption c) Combined with other diseases of the nervous system, pelvic floor and important organs d) Those who have not used artificial dura mater for nerve root sleeve reinforcement and reconstruction
-
Trial locations and contacts
1 site in 1 country.
About this study
A retrospective study of the changes in the VAS scores and imaging examinations after the reconstruction and reinforcement of nerve root sleeves and caudal angioplasty for the treatment of sacral cysts from August 2017 to January 2018 was used to evaluate the efficacy of the surgical prescription.
Read the detailed description
Objective: To clarify the curative effect of nerve root sleeve reconstruction and reinforcement and caudal plasty in the treatment of sacral cysts Design: A retrospective study of the changes in the VAS score and imaging examinations after the reconstruction and reinforcement of nerve root sleeves and sacral canoplasty for the treatment of sacral cysts from August 2017 to January 2018 to evaluate the efficacy of the surgical prescription.
- Conditions
- Tarlov Cysts
- Being tested
- nerve root sleeve reinforcement
- Keywords
- tarlov cysts surgery
- Medical subject headings
- Tarlov Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve root sleeve reinforcementProcedure or surgery
treatment of sacral cysts in patients with sacral cysts by using nerve root sleeve reinforcement
| Study group | Role | What they receive |
|---|---|---|
| the treatment of sacral cysts in patients with sacral cysts by using nerve root sleeve reinforcement | The clinical data of patients with sacral cysts treated with nerve root sleeve reinforcement and reconstruction of the sacral canal cyst were summarized and followed up from 3 to 6 months after the operation to form a case summary and report. Receives: Procedure: nerve root sleeve reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic nerve root cyst diagnosed by MRI
The capsule of the cyst is intact and the sacral lamina is not defective
,No other diseases of the nervous system, pelvic floor and important organs Reconstruction of patients with artificial dural nerve root sleeve reinforcement
Measured: 2017/08-2018/01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Aug 2017
- Primary completion30 Jan 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tarlov CystsStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- bin liu, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960462
- Sponsor's protocol ID
- M2018064
- Status last verified
- Jan 2017
- First submitted
- 4 Jul 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Report of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canal Plasty for the Treatment of Sacral Canal
- ClinicalTrials.gov ID
- NCT04960462
- Acronym / sponsor ID
- M2018064
- Conditions
- Tarlov Cysts
- Keywords
- tarlov cysts surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 13 Jul 2021 (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.
A retrospective study of the changes in the VAS scores and imaging examinations after the reconstruction and reinforcement of nerve root sleeves and caudal angioplasty for the treatment of sacral cysts from August 2017 to January 2018 was used to evaluate the efficacy of the surgical prescription.
Detailed description
Objective: To clarify the curative effect of nerve root sleeve reconstruction and reinforcement and caudal plasty in the treatment of sacral cysts Design: A retrospective study of the changes in the VAS score and imaging examinations after the reconstruction and reinforcement of nerve root sleeves and sacral canoplasty for the treatment of sacral cysts from August 2017 to January 2018 to evaluate the efficacy of the surgical prescription.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the treatment of sacral cysts in patients with sacral cysts by using nerve root sleeve reinforcement | – | Procedure: nerve root sleeve reinforcementThe clinical data of patients with sacral cysts treated with nerve root sleeve reinforcement and reconstruction of the sacral canal cyst were summarized and followed up from 3 to 6 months after the operation to form a case summary and report. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical data (symptoms, signs, imaging findings) of patients with sacral cysts treated with sacral cyst reconstruction using nerve root sleeve reinforcement
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 |
|---|---|---|
| nerve root sleeve reinforcementtreatment of sacral cysts in patients with sacral cysts by using nerve root sleeve reinforcement | Procedure or surgery | the treatment of sacral cysts in patients with sacral cysts by using nerve root sleeve reinforcement |
Primary outcome
Symptomatic nerve root cyst diagnosed by MRI
Time frame: 2017/08-2018/01
The capsule of the cyst is intact and the sacral lamina is not defective ,No other diseases of the nervous system, pelvic floor and important organs Reconstruction of patients with artificial dural nerve root sleeve reinforcement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Tarlov Cysts
Not yet recruitingObservational study
Long-Term Outcomes of Different Surgical Techniques for Sacral Tarlov Cysts: A Prospective Cohort Study
Sacral Tarlov Cysts, Symptomatic Sacral Cysts
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. This study is not recruiting at the moment.
bin liu study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tarlov Cysts, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic nerve root cyst diagnosed by MRI (time frame: 2017/08-2018/01). 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 Jul 2021.