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Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability

BMC Musculoskeletal Disorders, 2013 · DOI: 10.1186/1471-2474-14-52 · Published: January 31, 2013

Spinal Cord InjurySurgeryRehabilitation

Simple Explanation

This study compares early surgery to conservative treatment for incomplete cervical cord syndrome (ICSCL) without spinal instability, a condition often resulting from trauma. The goal is to determine which approach leads to better functional outcomes and quality of life for patients. The study, named COSMIC, aims to address the ongoing debate about whether early surgical intervention or conservative management is more effective for ICSCL patients without spinal instability. The primary outcome will be measured using the modified Japanese Orthopaedic Association (mJOA) score, assessing motor and sensory function, along with other scales to evaluate overall recovery and well-being.

Study Duration
Two years post-injury
Participants
72 adult patients
Evidence Level
Level 1: Randomized controlled trial

Key Findings

  • 1
    The primary outcome is clinical outcome according to mJOA, which is also measured by ASIA score, DASH score and SCIM III score.
  • 2
    Secondary outcomes include duration of stay at a high care department, hospital stay duration, complication rate, mortality rate, rehabilitation type, and quality of life.
  • 3
    The study hypothesizes that early surgical intervention will improve functional outcomes compared to conservative treatment in patients with ICSCL without spinal instability.

Research Summary

The COSMIC trial is designed to compare early surgical intervention with conservative treatment for patients with incomplete cervical cord syndrome without spinal instability. The study aims to determine which treatment strategy results in the best quality of life for patients and will contribute to more uniformity in treatment approaches for this specific type of spinal cord injury. Outcomes will be measured using a variety of validated scales, including mJOA, ASIA, DASH, and SCIM III, and will also assess cost-effectiveness from a societal perspective.

Practical Implications

Informed Treatment Decisions

The study results will provide evidence to guide clinical decision-making regarding surgical versus conservative management of ICSCL without spinal instability.

Improved Patient Outcomes

Identifying the optimal treatment strategy can lead to improved functional outcomes and quality of life for patients with this condition.

Standardized Treatment Approaches

The trial aims to reduce variability in clinical practice and promote more consistent and effective treatment protocols.

Study Limitations

  • 1
    Potential for surgeons' preferences to influence inclusion, despite protocol guidelines.
  • 2
    The inability to conduct a completely blind evaluation of treatment outcomes.
  • 3
    Possible difficulties in patient recruitment due to emotional distress and the need for legal representation.

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