Surgical Sectioning for Tethered Cord Syndrome

(OCCULT Trial)

Overseen By Jeffrey Greenfield, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Radiographic tethered cord, Prior lumbar surgery, CNS infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether surgery is more effective than medicine for treating Occult Tethered Cord Syndrome (OTCS), a condition where the spinal cord is abnormally attached, causing pain and other issues. The main treatment under evaluation is a surgery called "Release of filum terminale," which releases fibrous tissue at the end of the spinal cord to determine if it more effectively relieves symptoms. Participants will either undergo the surgery or continue with medical management to compare results. Ideal candidates have experienced symptoms that have not improved with medicine for at least a year and have been diagnosed with OTCS. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the surgical sectioning for tethered cord syndrome is safe?

Research has shown that surgery to release the filum terminale, a tissue strand at the end of the spinal cord, is generally safe for treating tethered cord syndrome. Studies have found that this surgery effectively improves symptoms for most patients, with many experiencing significant relief.

Most surgeries yield good results with few complications. However, the procedure carries a risk of injuring nearby nerves. Despite this risk, careful monitoring during surgery helps reduce potential harm. Overall, patients generally tolerate the surgery well, and the benefits often outweigh the risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the release of the filum terminale for tethered cord syndrome because it offers a direct surgical approach to alleviate tension on the spinal cord. Unlike standard treatments, which often focus on symptomatic relief or less invasive monitoring, this surgical method aims to directly address the root cause of the syndrome by cutting the filum terminale, a fibrous band that can restrict spinal cord movement. This approach could potentially provide more lasting relief from symptoms and improve quality of life for patients.

What evidence suggests that surgical sectioning is effective for Occult Tethered Cord Syndrome?

Research has shown that surgery to release the filum terminale can effectively treat tethered cord syndrome. In this trial, participants may undergo this surgical procedure. Studies have found that patients who underwent this surgery often experienced significant relief from their symptoms, especially those related to hypermobile Ehlers-Danlos syndrome (hEDS). Previous research suggests that surgery might be more effective than medication alone in managing symptoms of occult tethered cord syndrome (OTCS). This type of surgery is generally considered safe and offers a promising option for people with OTCS. ^{1 2 3 6 7}

Who Is on the Research Team?

Jeffrey Greenfield, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for people aged 2 to 79 with Occult Tethered Cord Syndrome (OTCS) who haven't improved after at least a year of medical treatment. They must score at least 30 on the OCCULT Grading Scale. It's not for those with visible signs of spinal issues, previous lumbar spine or spinal dysraphism surgeries, or a history of central nervous system infections or autoimmune diseases.

Inclusion Criteria

You have been diagnosed with Tethered Cord Syndrome

You have a total score of at least 30 on the OCCULT Grading Scale, which measures a type of skin condition.

I am between 2 and 79 years old.

Exclusion Criteria

I have a history of spinal cord issues related to Meningocele or Myelomeningocele.

I have had surgery on my lower back before.

I have visible skin markings indicating a dermal sinus tract.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either surgical untethering of the filum terminale or medical management

1 year

Regular visits for symptom assessment and adverse event monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Crossover

Subjects in the medical management arm may cross over to the surgical arm if deemed beneficial

After 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Release of filum terminale

Trial Overview The study tests if cutting the filum terminale—a fibrous tissue at the end of the spinal cord—is better than standard medical care in relieving symptoms of OTCS. The hypothesis suggests surgery could be more effective and that benefits may outweigh risks.

How Is the Trial Designed?

Group I: Surgery Active Control 1 Intervention

Filum release

Group II: Observation Active Control 1 Intervention

Medical Management only

Release of filum terminale is already approved in United States, European Union for the following indications:

Approved in United States as Filum Terminale Release for:

• Occult Tethered Cord Syndrome (OTCS)
• Symptomatic relief for OTCS patients

Approved in European Union as Filum Terminale Release for:

• Occult Tethered Cord Syndrome (OTCS)
• Symptomatic relief for OTCS patients

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

In a study of 152 patients who underwent section of a tight filum terminale, 8.6% experienced symptomatic retethering, with a median time of 23.4 months post-surgery, indicating that retethering is a notable risk even after this minimally invasive procedure.

Two patterns of retethering were identified: early retethering was associated with older age at surgery and more complications like arachnoiditis, while late retethering was linked to younger patients who had surgery earlier to prevent tethered cord symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptomatic retethering of the spinal cord after section of a tight filum terminale. Yong, RL., Habrock-Bach, T., Vaughan, M., et al.[2011]

The liver hanging maneuver (LHM) was associated with lower intraoperative blood loss and no need for blood transfusions in patients undergoing anatomical hepatectomy for large liver tumors, suggesting it may enhance safety during surgery.

Patients who underwent LHM had a shorter hospital stay and did not experience post-hepatectomy liver failure or bile leakage, indicating improved outcomes compared to those who did not receive the maneuver.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver hanging maneuver is suitable in major hepatectomy for liver malignancies over 5 cm. Nanashima, A., Hiyoshi, M., Imamura, N., et al.[2023]

The modified hanging maneuver using the Goldfinger dissector in laparoscopic liver resection was performed on 18 patients, demonstrating a median resection time of 96 minutes and minimal blood loss of 220 ml, indicating its efficacy and safety.

Only two complications (11%) were reported, which resolved spontaneously, suggesting that this technique is safe for use in major hepatectomies without the need for conversion to open surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified hanging maneuver using the goldfinger dissector in laparoscopic right and left hepatectomy. Troisi, RI., Montalti, R.[2019]

The study of 43 cadaveric livers revealed that the left triangular ligament (LTL) is closely attached to the appendix fibrosa hepatis (AFH), which can lead to accidental dissection of the AFH during surgical procedures.

Surgeons are advised to ligate the AFH securely rather than using electrocautery alone, as the AFH often contains large bile ducts and vascular structures that could complicate surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reconfirmation of the anatomy of the left triangular ligament and the appendix fibrosa hepatis in human livers, and its implication in abdominal surgery. Kogure, K., Kojima, I., Kuwano, H., et al.[2016]

In a study of 1,451 patients undergoing liver resection, the conventional liver mobilization approach was successful in 99.6% of cases, indicating its overall safety and efficacy.

Tape-assist techniques were used in 2.9% of cases to manage complex surgical situations, showing that while the conventional method is effective, tape-assist can enhance safety in specific circumstances without significantly affecting morbidity or survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significance of liver hanging maneuvers for invasive liver lesions in no-routine anterior approach policy. Shindoh, J., Hasegawa, K., Aoki, T., et al.[2021]

In a study of 342 patients who underwent untethering surgery for a tight filum terminale, the retethering rate was only 1.2%, which is lower than rates reported in previous studies, indicating the procedure's effectiveness.

By sectioning the filum terminale at a rostral level to the dural incision, the authors found this technique significantly reduced the occurrence of retethering, suggesting a safer surgical approach with favorable long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of retethering in untethering surgery of a tight filum terminale. Ogawa, S., Ogiwara, H.[2023]

A new microsurgical technique for treating tethered cord syndrome involves transecting the filum terminale below the conus tip, which may improve surgical outcomes by minimizing remnants of the filum.

This approach allows for complete removal of the distal portion of the filum through a less invasive interlaminar method, potentially reducing complications associated with traditional laminectomy techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microsurgical approach for resection of the filum terminale internum in tethered cord syndrome-a case demonstration of technical nuances and vignettes. Abdulrazeq, H., Shao, B., Sastry, RA., et al.[2023]

In a study of 15 adult patients undergoing tethered cord release, intraoperative neurophysiological monitoring significantly reduced the risk of nerve root injury, with no new neurological symptoms reported post-surgery.

The use of electrical stimulation revealed a dramatic difference in response thresholds between the filum terminale and motor nerve roots (100:1), aiding in the safe sectioning of the filum and resulting in improved bowel and bladder function in 46% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurophysiological monitoring for safe surgical tethered cord syndrome release in adults. Quiñones-Hinojosa, A., Gadkary, CA., Gulati, M., et al.[2004]

The liver hanging maneuver was successfully performed in 47 cases, demonstrating its feasibility and safety in protecting the inferior vena cava (IVC) during hepatectomy, with only one case experiencing severe bleeding.

This technique allows for clearer exposure of intrahepatic vessels and the ductal system, making the anterior approach for liver surgery safer and easier.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The significance of liver hanging maneuver in liver-splitting anterior approach for hepatectomy]. Peng, SY., Qian, HR., Li, JT., et al.[2005]

Retethering of the spinal cord can occur years after the surgical release of a tethered cord, as seen in two 13-year-old patients who experienced neurological deterioration due to this rare complication.

Surgical exploration and rerelease of the retethered filum terminale led to stabilization of bladder dysfunction and improvement in motor function, highlighting the importance of careful long-term monitoring and intervention for patients with a history of tethered spinal cord.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retethering of sectioned fibrolipomatous filum terminales: report of two cases. Souweidane, MM., Drake, JM.[2019]

In a review of 146 children who underwent surgery for tethered cord syndrome, 7.5% experienced retethering, with 36% of those initially asymptomatic at the time of their first surgery.

Repeat surgery for retethering was effective in alleviating new symptoms, suggesting that while some asymptomatic children may improve after surgery, they might not have needed the initial procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retethering in children after sectioning of the filum terminale. Vassilyadi, M., Tataryn, Z., Merziotis, M.[2018]

In a study of 248 patients under 18 years old who underwent tethered cord release surgery, both laminotomy and laminoplasty techniques showed no significant difference in early complication rates, with only 3.6% experiencing complications post-surgery.

Regardless of the surgical technique used, 97% of caregivers reported improvement in their child's condition after the procedure, indicating high efficacy of the surgery for treating tethered cord syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of lumbar laminoplasty vs. laminotomy for transection of the filum terminale does not affect early complication rates or postoperative course. Strong, MJ., Thompson, EM., Roundy, N., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35663696/

Patient-Reported Outcomes Following Sectioning of the ... Surgical release of the FT for TCS in patients with hEDS was safe and effective in this cohort. For most patients, there was a significant improvement in low ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9160501/

Patient-Reported Outcomes Following Sectioning of the ... Surgical release of the FT for TCS in patients with hEDS was safe and effective in this cohort. For most patients, there was a significant improvement in low ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05163899?term=AREA%5BConditionSearch%5D(%22Spina%20Bifida%20Occulta%22)&rank=1

Investigation of Surgical Sectioning of the Filum Terminale ... The exploratory hypothesis is that surgery for OTCS is both safe and more effective than medical management at relieving the symptoms of OTCS. Official Title.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878875022003291

Diseased Filum Terminale as a Cause of Tethered Cord ... We hypothesized that a diseased filum terminale (FT) might cause TCS in hEDS, justifying surgical transection for treatment.

5. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/40/6/article-p758.xml

Clinical criteria for filum terminale resection in occult ... The authors aimed to improve the diagnosis of occult tethered cord syndrome and assess outcome following filum terminale resection. Based on ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090301903008413

Neurophysiological monitoring for safe surgical tethered ... Release of tethered spinal cord by sectioning of the filum terminale carries a significant risk of injury to the neighboring motor and sensory nerve roots.

7. jss.amegroups.org jss.amegroups.org/article/view/4708/html

Pediatric tethered cord release: an epidemiological and ... Typically the filum is identified, coagulated, and cut, with satisfactory outcomes and overall low rate of complication pending the underlying pathology.