Long-Term Outcomes of Skull Base Repair for Spontaneous CSF Leaks

Studying Long-Term Results of Skull Base Repair for CSF Leaks

R
Rick Nelson, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
20 participants needed

Brief description of study

This is a prospective observational study with the purpose of evaluating the durability of the bone cement repair used to treat spontaneous cerebrospinal fluid leaks (SCSFL). Long-term follow-up data will be collected from the EMR from standard of care procedures. Additionally, subjects will be asked to complete a one-time questionnaire related to their symptoms and health.

THIS STUDY IS ENROLLING BY INVITATION ONLY - The study staff will screen for subject eligibility against the inclusion and exclusion criteria for all potential subjects. This will occur via chart review of scheduled clinic patients within the Neuroscience Center or hospital,. Some referrals may come from PI, clinical staff, and/or other research staff. Research staff will meet eligible patients to explain the study, review the consent form, ask the subject if they voluntarily agree to participate, and obtain consent.

Detailed description of study

Subjects will be asked to complete a one time questionnaire. The questionnaire is estimated to take 5-10 minutes to complete. Additionally, data will be collected from the EMR on the subjects if they agree to be a part of the study. 

Data collection may occur for as long as the subject receives care at IU/IU Health, until they withdraw from the study, or the study ends, whichever occurs first. This study will not change a patient's medical care.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cerebrospinal fluid leak, CSF leak
  • Age: 18 years - 100 years
  • Gender: All

Inclusion criteria:

1. Age greater than or equal to 18 years 

2. History of a craniotomy using bone cement repair for spontaneous cerebrospinal fluid leak 

3. Greater than or equal to 6 months post-operative from surgical repair for spontaneous cerebrospinal fluid leak using bone cement 

4. Able to understand English 4. Able to provide informed consent

This study investigates the long-term outcomes of repairing skull base defects using bone cement in patients with spontaneous cerebrospinal fluid (CSF) leaks. Cerebrospinal fluid is a clear fluid surrounding the brain and spinal cord, and a leak occurs when it escapes through a hole or tear in the skull base. This study will observe patients who have undergone this repair to understand how effective and durable the treatment is over time.

Participants will not undergo any changes to their usual medical care. Instead, the study will collect data from their existing medical records and ask them to complete a one-time questionnaire about their symptoms and health. This questionnaire will take about 5-10 minutes to complete. The study is observational, meaning it will collect information without altering the participants' treatment.

  • Who can participate: Adults aged 18 and older who have had a craniotomy with bone cement repair for a spontaneous cerebrospinal fluid leak at least 6 months ago can participate. Participants must understand English and be able to provide informed consent.
  • Study details: Participants will need to complete a one-time questionnaire about their symptoms and health, which will take approximately 5-10 minutes. Data will also be collected from their medical records as part of the study.
Updated on 20 May 2026. Study ID: OTHN-IIR-30717, 30717
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only