Nerve Graft Surgery for Spinal Cord Injury

Overseen By Kris P Dyer, MPH, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kentucky

Disqualifiers: Unconsciousness, ASIA grade C-E, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-blinded (with outcome assessors blinded to treatment allocation), 12-month pilot study to evaluate of the safety, feasibility, and preliminary efficacy of dorsal myelotomy and expansive duraplasty performed either without or with autologous nerve graft implantation after acute traumatic spinal cord injury. Ten participants will be allocated to receive either DMED (n=5) or DMED + ANGI (n=5) based on a block design. Participants and assessors will be blinded to group allocation. Excess sural nerve samples will be collected for banking/analysis (may include proteomic, culturing, genomic, cellular analysis).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Nerve Graft Surgery for Spinal Cord Injury?

Research suggests that expansion duraplasty, a component of the treatment, improves spinal cord decompression and physiological parameters more effectively than laminectomy alone, which may aid in recovery after spinal cord injury. ^{1 2 3 4 5}

Is nerve graft surgery for spinal cord injury generally safe for humans?

Surgical decompression, a procedure related to nerve graft surgery, is considered safe for patients with spinal cord injury, as no patients were made worse by the surgery. Durotomy, another related procedure, has shown positive effects on neurological function in most human studies, suggesting it may be safer than myelotomy. ^{1 2 6 7 8}

How is the treatment Spinal Decompression Surgery unique for spinal cord injury?

Spinal Decompression Surgery, including techniques like durotomy and expansive duraplasty, is unique because it directly addresses the pressure and swelling in the spinal cord by expanding the protective covering (dura) around it, which is not achieved by bone decompression alone. This approach aims to prevent further injury and improve recovery by reducing pressure on the injured spinal cord. ^{1 5 6 9 10}

Research Team

Francis H Farhadi, MD, PhD

Principal Investigator

University of Kentucky Neurosurgery

Eligibility Criteria

This trial is for adults aged 18-80 with acute traumatic spinal cord injury (SCI) at certain levels of the spine, who can consent and have surgery within 48 hours post-injury. Excluded are those with mild SCI, other serious conditions or mental impairments, substance abuse issues, pregnancy, involvement in another SCI study or if anterior-only spinal surgery is suitable.

Inclusion Criteria

I do not have any other life-threatening conditions.

I do not have sepsis.

My spinal cord injury is between my neck and mid-back without piercing the cord.

Exclusion Criteria

Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the principal investigator)

Unable to commit to the follow-up schedule

My spinal cord injury is moderate to mild, allowing some movement or sensation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dorsal myelotomy and expansive duraplasty (DMED) with or without autologous nerve graft implantation (ANGI)

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Nerve Graft Implantation
• Spinal Decompression

Trial Overview The study tests two surgical methods for treating acute SCI: DMED alone versus DMED combined with ANGI. It's a small-scale test to see if adding nerve grafts helps recovery. Participants won't know which treatment they get and neither will the assessors evaluating them.

Participant Groups

Group I: DMED Active Control 1 Intervention

Dorsal myelotomy and expansive duraplasty (DMED) only.

Group II: DMED + ANGI Active Control 2 Interventions

Dorsal myelotomy and expansive duraplasty (DMED) and supplemental autologous nerve graft implantation (ANGI).

Who Is Running the Clinical Trial?

University of Kentucky

Lead Sponsor

Trials

198

Recruited

224,000+

H. Francis Farhadi

Lead Sponsor

Trials

4

Recruited

410+

Spinal Cord and Brain Injury Research Center (SCOBIRC)

Collaborator

Trials

1

Recruited

10+

Findings from Research

In a study involving 72 rats with acute cervical spinal cord injury, the combination of decompressive durotomy and dural allograft placement led to better functional recovery compared to decompression alone.

Histological analysis showed that the group receiving the dural allograft had significantly reduced scar formation and inflammation, as well as smaller cavitation sizes, indicating that this approach may enhance healing after spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of early surgical decompression of the intradural space after cervical spinal cord injury in an animal model. Smith, JS., Anderson, R., Pham, T., et al.[2022]

Durotomy, a surgical procedure to relieve spinal cord compression, has shown positive effects on neurological function in 92.3% of human studies and 83.3% of animal studies, suggesting it may be a safer and more effective option than myelotomy.

In contrast, myelotomy has only shown effectiveness in 80% of animal studies and has had limited positive results in humans, with only one clinical study reporting improvements in motor and sensory function. More randomized controlled trials are needed to clarify the effectiveness of both procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of durotomy versus myelotomy in the repair of spinal cord injury. Telemacque, D., Zhu, FZ., Ren, ZW., et al.[2023]

In a study of 21 patients with acute severe traumatic spinal cord injury, the combination of laminectomy and duroplasty resulted in significantly better spinal cord decompression and improved physiological parameters compared to laminectomy alone.

The laminectomy+duroplasty group showed lower intraspinal pressure and higher spinal cord perfusion pressure, indicating better blood flow and pressure reactivity, although there were some complications like cerebrospinal fluid leaks that were manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expansion duroplasty improves intraspinal pressure, spinal cord perfusion pressure, and vascular pressure reactivity index in patients with traumatic spinal cord injury: injured spinal cord pressure evaluation study. Phang, I., Werndle, MC., Saadoun, S., et al.[2022]

In a study of 23 patients with traumatic spinal injuries, a combined technique of spinal shortening and interbody fusion effectively decompressed the spinal cord and achieved significant correction of spinal deformities, with the Cobb angle improving from 26 to 4 degrees post-surgery.

The procedure resulted in solid fusion and anatomical reconstruction in all patients, demonstrating its efficacy in managing unstable dorsal and lumbar injuries while minimizing loss of correction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal shortening and monosegmental posterior spondylodesis in the management of dorsal and lumbar unstable injuries. Aly, TA.[2021]

Monitoring intraspinal pressure through surgically implanted probes can provide critical information about spinal cord health and may improve management of acute spinal cord injuries.

Expansion duraplasty is being tested in a randomized controlled trial (DISCUS) as a potential effective treatment for severe traumatic cervical spinal cord injuries, addressing the limitations of traditional decompression methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute, Severe Traumatic Spinal Cord Injury: Monitoring from the Injury Site and Expansion Duraplasty. Saadoun, S., Papadopoulos, MC.[2022]

Acute surgical decompression, stabilization, and fusion for spinal cord injury is a safe procedure, with no patients experiencing worsened conditions post-surgery.

Patients with some preserved function and myelographic defects showed better recovery outcomes compared to those with normal myelograms who did not undergo surgery, indicating that surgery is beneficial for certain candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early surgical management of acute spinal cord injury. Ransohoff, J., Benjamin, V., Flamm, ES.[2004]

This case report describes a rare instance of dorsal herniation of the spinal cord in a 57-year-old male following surgery for a benign cyst, marking only the fifth reported case in the thoracolumbar spine.

Surgical reduction of the herniated cord and direct closure of the defect led to a full recovery, suggesting that effective management can be achieved without the need for a dural patch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior spinal cord herniation: a novel occurrence following surgery for an intramedullary cyst at the thoracolumbar junction. Zakaria, R., Ellenbogen, JR., Grewal, IS., et al.[2021]

Two cases of 35-year-old males with traumatic paraplegia developed Sub-acute Post-Traumatic Ascending Myelopathy (SPAM) after surgical decompression, showing that this is a potential complication following such procedures.

Both patients showed significant neurological improvement after receiving steroid treatment, highlighting the importance of prompt intervention and careful surgical techniques to minimize spinal cord handling during decompression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subacute post-traumatic ascending myelopathy (SPAM): two cases of SPAM following surgical treatment of thoracolumbar fractures. Farooque, K., Kandwal, P., Gupta, A.[2014]

Transplanting autoperipheral nerve tissues into chronic spinal cord injury sites in rats led to significant survival and integration of the grafts, promoting nerve regeneration and repair of the spinal cord.

Rats that received the nerve grafts showed improved motor function in their hind legs compared to the control group, indicating that this method could be an effective approach for treating chronic spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experimental study of peripheral nerve grafts for repairing of chronic spinal cord injury in adult rats]. Ma, WQ., Zhang, SC., Li, M., et al.[2008]

In a study involving two patients with complete cervical spinal cord injury, the addition of durotomy and expansile duraplasty to standard decompression and fixation procedures resulted in significant clinical improvement, with both patients improving from ASIA A to ASIA D.

This suggests that durotomy and duraplasty may be beneficial interventions for patients with complete spinal cord injuries undergoing surgical treatment, potentially preventing further injury and promoting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expansive Duraplasty - Simple Technique with Promising Results in Complete Cervical Spinal Cord Injury: A Preliminary Study. Garg, K., Agrawal, D., Hurlbert, RJ.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Role of early surgical decompression of the intradural space after cervical spinal cord injury in an animal model. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Effects of durotomy versus myelotomy in the repair of spinal cord injury. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Expansion duroplasty improves intraspinal pressure, spinal cord perfusion pressure, and vascular pressure reactivity index in patients with traumatic spinal cord injury: injured spinal cord pressure evaluation study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Spinal shortening and monosegmental posterior spondylodesis in the management of dorsal and lumbar unstable injuries. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Acute, Severe Traumatic Spinal Cord Injury: Monitoring from the Injury Site and Expansion Duraplasty. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Early surgical management of acute spinal cord injury. [2004]

7. Germany pubmed.ncbi.nlm.nih.gov

Posterior spinal cord herniation: a novel occurrence following surgery for an intramedullary cyst at the thoracolumbar junction. [2021]

8. India pubmed.ncbi.nlm.nih.gov

Subacute post-traumatic ascending myelopathy (SPAM): two cases of SPAM following surgical treatment of thoracolumbar fractures. [2014]

9. China pubmed.ncbi.nlm.nih.gov

[Experimental study of peripheral nerve grafts for repairing of chronic spinal cord injury in adult rats]. [2008]

10. India pubmed.ncbi.nlm.nih.gov

Expansive Duraplasty - Simple Technique with Promising Results in Complete Cervical Spinal Cord Injury: A Preliminary Study. [2022]