Study of Duroplasty Surgery to Improve Recovery After Severe Neck Spinal Cord Injury Comparing Standard Surgery With and Without Duroplasty

What this Trial Is About

Researchers are investigating whether adding duroplasty, a surgical procedure that expands the tough membrane around the spinal cord, improves outcomes after severe cervical spinal cord injury. This trial focuses on adults with acute, severe injuries in the neck area who require surgery within 72 hours. The study aims to determine if duroplasty combined with standard bony decompression surgery enhances muscle strength and functional recovery compared to bony decompression alone. Participants will be randomly assigned to receive either standard spinal surgery including laminectomy alone or the same surgery plus duroplasty. Some patients may also join an optional mechanistic sub-study where probes and microdialysis catheters monitor spinal cord pressure, blood flow, metabolism, and inflammation at the injury site. The study will recruit around 222 to 260 patients over four years, including sites in the UK and internationally. During the study, participants will be assessed at baseline, 3, 6, and 12 months after surgery using questionnaires and physical examinations to measure muscle strength, hand function, walking ability, bladder and bowel control, and quality of life. Some will have MRI scans at 2 weeks and 6 months, and safety outcomes such as complications, additional surgeries, and mortality will be tracked up to 12 months. Follow-up lasts one year to evaluate recovery and treatment impact.

Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling