Duroplasty for injured cervical spinal cord with uncontrolled swelling: protocol of the DISCUS randomized controlled trial

Trials, 2023 · DOI: https://doi.org/10.1186/s13063-023-07454-2 · Published: June 13, 2023

Spinal Cord Injury Surgery Research Methodology & Design

Simple Explanation

This study, DISCUS, aims to determine if adding duroplasty to standard bony decompression surgery improves outcomes for patients with severe cervical traumatic spinal cord injuries (TSCI). Duroplasty involves opening the dura (the membrane around the spinal cord) and adding a patch to expand the space. The trial will compare patients undergoing bony decompression alone versus those undergoing bony decompression with duroplasty. The primary outcome is the change in muscle strength in the limbs at 6 months. An optional mechanistic study will also be conducted to investigate whether duroplasty reduces cord compression, improves perfusion, and reduces ischemia and inflammation in the spinal cord.

Study Duration

72 months

Participants

222 adults with acute, severe, traumatic cervical spinal cord injury

Evidence Level

Level III, Randomized controlled superiority trial

Key Findings

1
The primary objective is to test the hypothesis that, in patients with severe cervical TSCI, bony + dural decompression, compared with bony decompression alone, improves American Spinal Injury Association Impairment Scale (AIS) motor score (AMS) at 6 months.
2
Secondary outcomes include improvements in neurological and functional outcomes at 6 months, quality of life at 6 and 12 months, MRI features, spinal cord perfusion, and safety.
3
The study anticipates that the addition of duroplasty to standard of care will improve muscle strength, with benefits for patients, carers, health services, and society.

Research Summary

The DISCUS trial is a prospective, phase III, multicenter, randomized controlled superiority trial designed to assess whether the addition of duroplasty to bony decompression improves muscle strength in patients with acute, severe traumatic cervical spinal cord injury. The study aims to recruit 222 adults with severe cervical TSCI, randomizing them to either bony decompression alone or bony decompression with duroplasty. The primary outcome is the change in motor score at 6 months. An integrated QuinteT recruitment intervention (QRI) is included to optimize recruitment and informed consent processes, particularly in UK centers during the initial recruitment phase.

Practical Implications

Improved Patient Outcomes

If duroplasty proves beneficial, it could become a standard of care, improving muscle strength and overall outcomes for patients with severe cervical TSCI.

Economic Benefits

Improved patient outcomes can lead to substantial gains for health services and society, including economic implications.

Enhanced Understanding of SCI

The mechanistic study will provide valuable insights into the pathophysiology of spinal cord injury and the mechanisms by which duroplasty may improve outcomes.

Study Limitations

1
The pool of eligible patients is relatively small (9–13 patients per year per center).
2
Recruitment is led by busy neurosurgical trainees who may not prioritize trial recruitment in high-pressure surgical environments.
3
There may be issues with equipoise if surgeons favor an anterior approach and if patients or families favor the novel procedure.

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