Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury

Condition(s) studied

Investigational drug(s) / intervention(s)

Expansile duraplasty: For participants receiving expansile duraplasty during standard spinal surgery, the dura mater is longitudinally incised along the midline, followed by watertight augmented repair with autologous fascial graft to expand the intrathecal space and accommodate edematous spinal cord after trauma. The length of the dural incision matches the extent of spinal cord edema shown on preoperative MRI. This duraplasty procedure is performed concurrently with the index surgery for traumatic spinal cord injury, rather than as a staged or delayed secondary operation. The pia mater and spinal cord parenchyma remain intact and are not incised intraoperatively.

Study summary

The goal of this clinical trial is to learn whether expansile duraplasty can improve neurological recovery in adult patients with acute severe traumatic spinal cord injury, as well as evaluate the safety of this surgical strategy. The main questions the study aims to answer are:

1. Does expansile duraplasty lead to superior motor function recovery in patients with acute severe traumatic spinal cord injury?
2. How safe is the use of expansile duraplasty in people with acute traumatic SCI?

Researchers will compare neurological function, quality of life and all safety indicators who receive expansile duraplasty to that of participants who do not receive expansile duraplasty, to determine whether the additional expansile duraplasty provides better recovery benefits for patients with traumatic spinal cord injury.

Participants will be randomly assigned to one of two groups: the laminectomy combined with expansile duraplasty group and the laminectomy-only group. All participants will complete the following procedures:

1. Receive standardized spinal surgery ;
2. Provide blood and cerebrospinal fluid samples during hospitalization;
3. Undergo spinal computed tomography (CT) and magnetic resonance imaging (MRI) scans at baseline (pre-operation), discharge, 3 months, 6 months and 12 months after surgery;
4. Complete standardized neurological assessments at 3, 6 and 12 months postoperatively, including ASIA motor and sensory scores, Walking Index for Spinal Cord Injury II (WISCI II), and Spinal Cord Independence Measure III (SCIM III);
5. Fill out questionnaires at each follow-up visit, including the 36-Item Short Form Health Survey (SF-36);
6. Be continuously monitored for all adverse events and surgical complications throughout the 12-month follow-up period.

Eligibility

Primary outcome measure(s)

• Change in AIS motor score — 6 months versus baseline
  Change in American Spinal Injury Association Impairment Scale total limb motor score at 6 months

Trial sites (13)

More Xuanwu Hospital, Beijing trials in China

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