First Human Implantation of a Bioresorbable Polymer Scaffold for Acute Traumatic Spinal Cord Injury

Neurosurgery ◽  
2016 ◽  
Vol 79 (2) ◽  
pp. E305-E312 ◽  
Author(s):  
Nicholas Theodore ◽  
Randall Hlubek ◽  
Jill Danielson ◽  
Kristin Neff ◽  
Lou Vaickus ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Supplemental Digital Content ◽  
Digital Content ◽  
Traumatic Spinal Cord Injury ◽  
Polymer Scaffold ◽  
Cord Injury ◽  
Bioresorbable Polymer ◽  
Human Implantation

Abstract SUPPLEMENTAL DIGITAL CONTENT Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.neurosurgery-online.com). BACKGROUND AND IMPORTANCE: A porous bioresorbable polymer scaffold has previously been tested in preclinical animal models of spinal cord contusion injury to promote appositional healing, spare white matter, decrease posttraumatic cysts, and normalize intraparenchymal tissue pressure. This is the first report of its human implantation in a spinal cord injury patient during a pilot study testing the safety and feasibility of this technique (ClinicalTrials.gov Identifier: NCT02138110). CLINICAL PRESENTATION: A 25-year-old man had a T11-12 fracture dislocation sustained in a motocross accident that resulted in a T11 American Spinal Injury Association Impairment Scale (AIS) grade A traumatic spinal cord injury. He was treated with acute surgical decompression and spinal fixation with fusion, and enrolled in the spinal scaffold study. A 2 × 10 mm bioresorbable scaffold was placed in the spinal cord parenchyma at T12. The scaffold was implanted directly into the traumatic cavity within the spinal cord through a dorsal root entry zone myelotomy at the caudal extent of the contused area. By 3 months, his neurological examination improved to an L1 AIS grade C incomplete injury. At 6-month postoperative follow-up, there were no procedural complications or apparent safety issues related to the scaffold implantation. CONCLUSION: Although longer-term follow-up and investigation are required, this case demonstrates that a polymer scaffold can be safely implanted into an acutely contused spinal cord. This is the first human surgical implantation, and future outcomes of other patients in this clinical trial will better elucidate the safety and possible efficacy profile of the scaffold.

scholarly journals A multicentre follow-up of clinical aspects of traumatic spinal cord injury

Spinal Cord ◽  
2006 ◽  
Vol 45 (6) ◽  
pp. 404-410 ◽  
Author(s):  
M C Pagliacci ◽  
◽  
M Franceschini ◽  
B Di Clemente ◽  
M Agosti ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Aspects ◽  
Traumatic Spinal Cord Injury ◽  
Cord Injury

Late neurological changes following traumatic spinal cord injury

1988 ◽  
Vol 69 (3) ◽  
pp. 399-402 ◽  
Author(s):  
Joseph M. Piepmeier ◽  
N. Ross Jenkins
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Spinal Cord Injuries ◽  
Neurological Status ◽  
Neurological Function ◽  
Traumatic Spinal Cord Injury ◽  
Content Type ◽  
Cord Injury ◽  
Fine Print

✓ Sixty-nine patients with traumatic spinal cord injuries were evaluated for changes in their functional neurological status at discharge from the hospital, and at 1 year, 3 years, and 5+ years following injury. The neurological examinations were used to classify patients' spinal cord injury according to the Frankel scale. This analysis revealed that the majority of improvement in neurological function occurred within the 1st year following injury; however, changes in the patients' status continued for many years. Follow-up examinations at an average of 3 years postinjury revealed that 23.3% of the patients continued to improve, whereas 7.1% had deteriorated compared to their status at 1 year. An examination at an average of 5+ years demonstrated further improvement in 12.5%, with 5.0% showing deterioration compared to the examinations at 3 years. These results demonstrate that, in patients with spinal trauma, significant changes in neurological function continue for many years.

scholarly journals Neurogenic bladder in patients with traumatic spinal cord injury: treatment and follow-up

Spinal Cord ◽  
2014 ◽  
Vol 52 (6) ◽  
pp. 462-467 ◽  
Author(s):  
N Yıldız ◽  
◽  
Y Akkoç ◽  
B Erhan ◽  
B Gündüz ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Neurogenic Bladder ◽  
Traumatic Spinal Cord Injury ◽  
Cord Injury ◽  
Injury Treatment

Acute, severe traumatic spinal cord injury: improving urinary bladder function by optimizing spinal cord perfusion

2021 ◽  
pp. 1-8
Author(s):  
Florence R. A. Hogg ◽  
Siobhan Kearney ◽  
Eskinder Solomon ◽  
Mathew J. Gallagher ◽  
Argyro Zoumprouli ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Urinary Bladder ◽  
Perfusion Pressure ◽  
Bladder Function ◽  
Traumatic Spinal Cord Injury ◽  
Injury Site ◽  
Bladder Compliance ◽  
Cord Injury

OBJECTIVE The authors sought to investigate the effect of acute, severe traumatic spinal cord injury on the urinary bladder and the hypothesis that increasing the spinal cord perfusion pressure improves bladder function. METHODS In 13 adults with traumatic spinal cord injury (American Spinal Injury Association Impairment Scale grades A–C), a pressure probe and a microdialysis catheter were placed intradurally at the injury site. We varied the spinal cord perfusion pressure and performed filling cystometry. Patients were followed up for 12 months on average. RESULTS The 13 patients had 63 fill cycles; 38 cycles had unfavorable urodynamics, i.e., dangerously low compliance (< 20 mL/cmH2O), detrusor overactivity, or dangerously high end-fill pressure (> 40 cmH2O). Unfavorable urodynamics correlated with periods of injury site hypoperfusion (spinal cord perfusion pressure < 60 mm Hg), hyperperfusion (spinal cord perfusion pressure > 100 mm Hg), tissue glucose < 3 mM, and tissue lactate to pyruvate ratio > 30. Increasing spinal cord perfusion pressure from 67.0 ± 2.3 mm Hg (average ± SE) to 92.1 ± 3.0 mm Hg significantly reduced, from 534 to 365 mL, the median bladder volume at which the desire to void was first experienced. All patients with dangerously low average initial bladder compliance (< 20 mL/cmH2O) maintained low compliance at follow-up, whereas all patients with high average initial bladder compliance (> 100 mL/cmH2O) maintained high compliance at follow-up. CONCLUSIONS We conclude that unfavorable urodynamics develop within days of traumatic spinal cord injury, thus challenging the prevailing notion that the detrusor is initially acontractile. Urodynamic studies performed acutely identify patients with dangerously low bladder compliance likely to benefit from early intervention. At this early stage, bladder function is dynamic and is influenced by fluctuations in the physiology and metabolism at the injury site; therefore, optimizing spinal cord perfusion is likely to improve urological outcome in patients with acute severe traumatic spinal cord injury.

Mortality after traumatic spinal cord injury: 50 years of follow-up

2009 ◽  
Vol 81 (4) ◽  
pp. 368-373 ◽  
Author(s):  
E. M. Hagen ◽  
S. A. Lie ◽  
T. Rekand ◽  
N. E. Gilhus ◽  
M. Gronning
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Traumatic Spinal Cord Injury ◽  
Cord Injury

Incidence of skeletal fractures after traumatic spinal cord injury: a 10-year follow-up study

2013 ◽  
Vol 28 (4) ◽  
pp. 361-369 ◽  
Author(s):  
Laia Gifre ◽  
Joan Vidal ◽  
Josep Carrasco ◽  
Enric Portell ◽  
Josep Puig ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Traumatic Spinal Cord Injury ◽  
Follow Up Study ◽  
Cord Injury

scholarly journals A study of probable benefit of a bioresorbable polymer scaffold for safety and neurological recovery in patients with complete thoracic spinal cord injury: 6-month results from the INSPIRE study

2021 ◽  
pp. 1-10
Author(s):  
Kee D. Kim ◽  
K. Stuart Lee ◽  
Domagoj Coric ◽  
Jason J. Chang ◽  
James S. Harrop ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Conversion Rate ◽  
Neurological Recovery ◽  
Thoracic Spinal Cord ◽  
Intramedullary Spinal Cord ◽  
Cord Injury ◽  
Bioresorbable Polymer ◽  
Implantation Procedure

OBJECTIVEThe aim of this study was to evaluate whether the investigational Neuro-Spinal Scaffold (NSS), a highly porous bioresorbable polymer device, demonstrates probable benefit for safety and neurological recovery in patients with complete (AIS grade A) T2–12 spinal cord injury (SCI) when implanted ≤ 96 hours postinjury.METHODSThis was a prospective, open-label, multicenter, single-arm study in patients with a visible contusion on MRI. The NSS was implanted into the epicenter of the postirrigation intramedullary spinal cord contusion cavity with the intention of providing structural support to the injured spinal cord parenchyma. The primary efficacy endpoint was the proportion of patients who had an improvement of ≥ 1 AIS grade (i.e., conversion from complete paraplegia to incomplete paraplegia) at the 6-month follow-up visit. A preset objective performance criterion established for the study was defined as an AIS grade conversion rate of ≥ 25%. Secondary endpoints included change in neurological level of injury (NLI). This analysis reports on data through 6-month follow-up assessments.RESULTSNineteen patients underwent NSS implantation. There were 3 early withdrawals due to death, which were all determined by investigators to be unrelated to the NSS or the implantation procedure. Seven of 16 patients (43.8%) who completed the 6-month follow-up visit had conversion of neurological status (AIS grade A to grade B [n = 5] or C [n = 2]). Five patients showed improvement in NLI of 1 to 2 levels compared with preimplantation assessment, 3 patients showed no change, and 8 patients showed deterioration of 1 to 4 levels. There were no unanticipated or serious adverse device effects or serious adverse events related to the NSS or the implantation procedure as determined by investigators.CONCLUSIONSIn this first-in-human study, implantation of the NSS within the spinal cord appeared to be safe in the setting of surgical decompression and stabilization for complete (AIS grade A) thoracic SCI. It was associated with a 6-month AIS grade conversion rate that exceeded historical controls. The INSPIRE study data demonstrate that the potential benefits of the NSS outweigh the risks in this patient population and support further clinical investigation in a randomized controlled trial.Clinical trial registration no.: NCT02138110 (clinicaltrials.gov)

Survival in Persons With Traumatic Spinal Cord Injury Receiving Structured Follow-Up in South India

2014 ◽  
Vol 95 (4) ◽  
pp. 642-648 ◽  
Author(s):  
Apurba Barman ◽  
Devika Shanmugasundaram ◽  
Rohit Bhide ◽  
Anand Viswanathan ◽  
Henry Prakash Magimairaj ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
South India ◽  
Traumatic Spinal Cord Injury ◽  
Cord Injury

Urodynamic study of Bladder Behaviour in Traumatic Spinal Cord Injury Patients in Response to Rehabilitation

2013 ◽  
Vol 24 (4) ◽  
pp. 87-91
Author(s):  
Singh Ningthoujam Jungindro ◽  
Keshkar Sanjay, ◽  
Singh Naorem Ajit ◽  
Kumar Ratnesh
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Motor Neuron ◽  
Neurogenic Bladder ◽  
Traumatic Spinal Cord Injury ◽  
Urodynamic Study ◽  
Rehabilitation Intervention ◽  
Cord Injury ◽  
Bladder Rehabilitation

Abstract Objective To study the bladder behaviour in response to rehabilitation intervention in traumatic spinal cord injury (SCI) patients using urodynamic study (UDS) and to compare the nature of the bladder in a rehabilitated and nonrehabilitated neurogenic bladder of traumatic SCI. Study design Prospective follow-up study. Setting Rehabilitation ward of National Institute for the Orthopaedically Handicapped. Material and Method Thirty traumatic SCI patients mean age 31.4±7.9 years, 26 males and 4 females, admitted for rehabilitation were done UDS to see the bladder behaviour in response to rehabilitation intervention and compare the nature of bladder of the rehabilitated and that of the non-rehabilitated neurogenic bladder. Rehabilitation of the bladder was done at least for three months. The study lasted for 2 years with a minimum of one year follow-up. Result In upper motor neuron (UMN) neurogenic bladders there were significant changes in the max. cystometric capacity (p=0.018) after rehab intervention. The compliance, Pdet. at first desire to void and Pdet. at max. cystometric capacity of these patients were also found to have significant correlations (p=0.012, 0.010 and 0.014 respectively). But the volume at the first desire to void does not show must significant changes after rehab intervention (p=0.45). Significant reduction of amplitude and frequency was found in involuntary contractions (detrusor hyper-reflexia). In similar comparison of the lower motor neuron (LMN) neurogenic bladder significant changes after rehab intervention, could be found only in the max. cystometric capacity (p=0.018). Other variables like compliance, volume at first desire to void, Pdet. at first desire to void, and Pdet. at max. cystometric capacity were found to have no significant changes after rehab intervention (p=0.168, 0.194, 0.324, 0.302 respectively). Conclusion The change in the nature of the rehabilitated neurogenic bladder is different with the type of bladder.

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