Status:
UNKNOWN
Efficacy and Safety of Nerve Root Axial Decompression Surgery in The Treatment of Tethered Cord Syndrome
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Tethered Cord Syndrome
Eligibility:
All Genders
14-20 years
Phase:
NA
Brief Summary
Background: Tethered cord syndrome (TCS) is a progressive clinical condition including a series of neurological dysfunctions and deformities attributable to abnormally increased tension on the spinal ...
Detailed Description
Background: Tethered cord syndrome (TCS) is a progressive clinical condition including a series of neurological dysfunctions and deformities attributable to abnormally increased tension on the spinal ...
Eligibility Criteria
Inclusion
- patients aged 14-20 years, without gender limitation, are willing to sign informed consent;
- patients diagnosed with tethered cord syndrome (TCS);
- patients accepted untethering surgery or resection of intra-lipomas or myelomeningocele after birth;
- patients present with the recent occurrence of bladder or bowel dysfunction, with progressive deterioration, may be accompanied by motor deficits of lower extremity;
- urodynamic examination suggests neurogenic injury;
- the current conventional treatment is difficult to achieve satisfactory clinical outcomes.
Exclusion
- bladder or ureter obstruction;
- other types of neurogenic bladder dysfunction (spinal cord injury, cerebral palsy, other brain injuries);
- anorectal malformations;
- poor health condition, unable to tolerate surgery;
- patients (or their guardians) cannot give full informed consent for cognitive dysfunction;
- patients who have participated in other clinical trials in the past 1 month.
- patients with active hepatitis B (including HBeAg) or serological markers (HBsAg or / and HBeAg or / and HBcAb), hepatitis C, tuberculosis, cytomegalovirus infection, severe fungal infection or HIV infection;
- patients with active peptic ulcers within 3 months before randomization.
- patients with malignant neoplasms
Key Trial Info
Start Date :
June 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03262844
Start Date
June 16 2017
End Date
April 1 2020
Last Update
September 27 2018
Active Locations (1)
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1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200001