Traumatic Spinal Cord InjuryNCT07583836
DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY
An observational study of Traumatic Spinal Cord Injury, run by Fauji Foundation Hospital at 1 site in Pakistan.
Trial summary
To compare the outcome of early versus delayed surgical decompression among patients presenting with traumatic spinal cord injury in a tertiary care hospital. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Spinal Cord Injury
- What is being tested?
- Early Surgical Decompression and Delayed Surgical Decompression
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: • Patients presenting with spinal cord injury (both cervical and thoracic)
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Fauji Foundation Hospital, Rawalpindi
Rawalpindi
Salman Dr, MBBS, +92 322 6192355, xalmantahir@gmail.com
About this study
Official title: COMPARISON OF DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY
To compare the outcome of early versus delayed surgical decompression among patients presenting with traumatic spinal cord injury in a tertiary care hospital.
Read the detailed description
Despite the increasing advocacy for early surgery, significant variability persists in clinical practice. This inconsistency stems from conflicting evidence in the literature, with some studies reporting substantial neurological benefits from early intervention, while others find no significant difference compared to delayed surgery. Similarly, in our institute, both early and delayed decompressions are in practice, whichever considered suitable by the experts. But no study has done to date that compare the outcome of both techniques. Given these gaps, there is a pressing need for a comprehensive evaluation of the existing evidence to determine the optimal timing of surgical intervention for acute traumatic SCI especially among our local population where past evidence is scarce. So, this study seeks to contribute to this critical discourse by systematically evaluating the impact of early versus delayed surgical decompression on clinical outcomes in our local population. The study would not only add evidence to the global and local data but would also help the surgeons to choose the better technique in future as the technique with better outcome would be preferred in future among all the local patients who will present to our hospital with acute SCI. Adopting the treatment strategy with better outcome would also help to reduce the overall morbidity associated with a cute SCI in our local population.
Finally objectives are , to compare the outcome of early versus delayed surgical decompression among patients presenting with traumatic spinal cord injury in a tertiary care hospital.
- Conditions
- Traumatic Spinal Cord Injury
- Being tested
- Early Surgical Decompression, Delayed Surgical Decompression
- Keywords
- Traumatic Spinal Cord Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Surgical DecompressionProcedure or surgery
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.
Delayed Surgical DecompressionProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start30 Aug 2025
- Primary completion1 Mar 2026
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fauji Foundation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583836
- Sponsor's protocol ID
- 999/RC/FFH/RWP
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY
- ClinicalTrials.gov ID
- NCT07583836
- Acronym / sponsor ID
- 999/RC/FFH/RWP
- Conditions
- Traumatic Spinal Cord Injury
- Keywords
- Traumatic Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fauji Foundation HospitalUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the outcome of early versus delayed surgical decompression among patients presenting with traumatic spinal cord injury in a tertiary care hospital.
Detailed description
Despite the increasing advocacy for early surgery, significant variability persists in clinical practice. This inconsistency stems from conflicting evidence in the literature, with some studies reporting substantial neurological benefits from early intervention, while others find no significant difference compared to delayed surgery. Similarly, in our institute, both early and delayed decompressions are in practice, whichever considered suitable by the experts. But no study has done to date that compare the outcome of both techniques. Given these gaps, there is a pressing need for a comprehensive evaluation of the existing evidence to determine the optimal timing of surgical intervention for acute traumatic SCI especially among our local population where past evidence is scarce. So, this study seeks to contribute to this critical discourse by systematically evaluating the impact of early versus delayed surgical decompression on clinical outcomes in our local population. The study would not only add evidence to the global and local data but would also help the surgeons to choose the better technique in future as the technique with better outcome would be preferred in future among all the local patients who will present to our hospital with acute SCI. Adopting the treatment strategy with better outcome would also help to reduce the overall morbidity associated with a cute SCI in our local population.
Finally objectives are , to compare the outcome of early versus delayed surgical decompression among patients presenting with traumatic spinal cord injury in a tertiary care hospital.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- • Patients presenting with spinal cord injury (both cervical and thoracic)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Surgical Decompressionit 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. | Procedure or surgery | – |
| Delayed Surgical DecompressionIt 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. | Procedure or surgery | – |
Primary outcome
improvement in neurological impairment using ASIA Impairment Scale (AIS)
Time frame: 12 Weeks after surgery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Related trials for Traumatic Spinal Cord Injury
Active, not recruitingPhase 1/2
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
Heterotopic Ossification (HO)
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
RecruitingPhase 2/3
Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
Spinal Cord Injury, Traumatic Spinal Cord Injury
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
Recruiting
Functional Electrical Stimulation vs Transcutaneous Stimulation in Patients With Subacute Spinal Cord Injury
Non Traumatic Spinal Cord Injury, Sub-Acute Rehabilitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Spinal Cord Injury, run by Fauji Foundation Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Salman Tahir, MBBS (+92 322 6192355, ffh.rawalpindi@fauji.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in neurological impairment using ASIA Impairment Scale (AIS) (time frame: 12 Weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.