Status:
NOT_YET_RECRUITING
A Randomized Controlled Trial for Surgical Treatment of Recurrent Adult Tethered Cord Syndrome
Lead Sponsor:
Xuanwu Hospital, Beijing
Collaborating Sponsors:
Chinese PLA General Hospital
Seventh Medical Center of PLA Army General Hospital
Conditions:
Recurrent Adult Tethered Cord Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This trial compares detethering surgery and spinal column shortening surgery, two treatments for adults with recurrent tethered cord syndrome (TCS), a neurological disorder where the spinal cord becom...
Detailed Description
This study is a multicenter, prospective, randomized controlled trial designed to compare the effectiveness and safety of detethering surgery and spinal column shortening surgery in adults diagnosed w...
Eligibility Criteria
Inclusion
- Patients who have previously detethering surgery for primary tethered cord syndrome, including filum terminale untethering, dermoid or lipoma resection, with a recurrence of spinal cord tethering postoperatively.
- The presence of related clinical symptoms, including bowel and bladder dysfunction, sensory impairment, numbness, pain in the lower limbs, perineal or buttock area, motor dysfunction of the lower limbs, muscle weakness, and sexual dysfunction.
- Primary diagnosis of a thickened filum terminale, low-lying conus medullaris, meningocele, lipoma, dermoid, or spina bifida.
Exclusion
- Patients with severe scoliosis at the thoracolumbar junction.
- Patients with severe osteoporosis or other conditions that contraindicate internal fixation.
- Patients with severe pressure ulcers or skin breakdown in the lumbar or thoracic region.
- Patients with severe systemic diseases that cannot tolerate surgery.
- Other cases deemed unsuitable for inclusion following evaluation by professional neurosurgeons.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT06197399
Start Date
February 1 2024
End Date
May 31 2027
Last Update
January 9 2024
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, China, 100000