NCT07583836

Brief Summary

To compare the outcome of early versus delayed surgical decompression among patients presenting with traumatic spinal cord injury in a tertiary care hospital.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 7, 2026

Last Update Submit

May 7, 2026

Conditions

Keywords

Traumatic Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • improvement in neurological impairment using ASIA Impairment Scale (AIS)

    Treatment outcomes will be measured 12 weeks after early or delayed surgical decompression among all the patients who underwent spinal cord injury in terms of improvement in neurological impairment using ASIA Impairment Scale (AIS) attached as annexure-C. Outcome will be labelled as good if shows improvement for at least two AIS grades.

    12 Weeks after surgery

Interventions

it will be defined as the surgical decompression performed within 24 hours of injury. It will be performed among all the patients who presented within 24 hours of injury.

It will be defined as the surgical decompression performed after 24 hours of spinal cord injury. It will be performed among all the patients who needed it due to medical optimization (such as hemodynamically unstable, shock, pulmonary contusions, cerebrovascular destabilization etc.) or those who will present after 24 hours of injury due to logistical delay.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

• Patients presenting with spinal cord injury (both cervical and thoracic)

You may qualify if:

  • Patients presenting with spinal cord injury (both cervical and thoracic) as per described in the operational definition
  • Age from 18-60 years
  • Both male and female patients

You may not qualify if:

  • Patients with penetrating spinal injuries such as gunshot/stab wounds
  • Patients with pre-existing neurological conditions like myelopathy etc.
  • Patients with any kind of malignancy
  • Patients having CSF infection etc.
  • Patients who are not fit for general anesthesia (i.e. ASA Grade \>2 Annexure-B)
  • Diagnosis of subclinical or clinical polyneuropathy
  • Non-traumatic or pathological fractures or cord compression
  • Inability to cooperate with preoperative physical examination because of cognitive impairment
  • Patients with previous spinal column or SCI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation Hospital, Rawalpindi

Rawalpindi, Pakistan

RECRUITING

Central Study Contacts

Dr. Salman Tahir, MBBS

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 13, 2026

Study Start

August 30, 2025

Primary Completion

March 1, 2026

Study Completion

June 1, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Locations