Studying missingness in spinal cord injury data: challenges and impact of data imputation.

Background: In the last decades, medical research fields studying rare conditions such as spinal cord injury (SCI) have made extensive efforts to collect large-scale data. However, most analysis methods rely on complete data. This is particularly troublesome when studying clinical data as they are prone to missingness.

Early vs Late Surgical Decompression for Central Cord Syndrome.

Importance: The optimal clinical management of central cord syndrome (CCS) remains unclear; yet this is becoming an increasingly relevant public health problem in the face of an aging population.

Objective: To provide a head-to-head comparison of the neurologic and functional outcomes of early (<24 hours) vs late (≥24 hours) surgical decompression for CCS.

Design, Setting, And Participants: Patients who underwent surgery for CCS (lower extremity motor score [LEMS] - upper extremity motor score [UEMS] ≥ 5) were included in this propensity score-matched cohort study.

A Novel Method to Classify Cervical Incomplete Spinal Cord Injury Based on Potential for Recovery: A Group-Based Trajectory Analysis.

The outcomes of cervical incomplete spinal cord injury (SCI) are heterogeneous. This study sought to dissociate subgroups of cervical incomplete SCI patients with distinct longitudinal temporal profiles of recovery in upper limb motor function. Patients with cervical incomplete SCI (American Spinal Injury Association Impairment Scale [AIS] B-D; C1-C8) were identified from four prospective, multi-center SCI datasets.

Routine Blood Chemistry Predicts Functional Recovery After Traumatic Spinal Cord Injury: A Post Hoc Analysis.

Background: Spinal cord injury (SCI) leads to various degrees of lifelong functional deficits. Most individuals with incomplete SCI experience a certain degree of functional recovery, especially within the first-year postinjury. However, this is difficult to predict, and surrogate biomarkers are urgently needed.

The influence of timing of surgical decompression for acute spinal cord injury: a pooled analysis of individual patient data.

Background: Although there is a strong biological rationale for early decompression of the injured spinal cord, the influence of the timing of surgical decompression for acute spinal cord injury (SCI) remains debated, with substantial variability in clinical practice. We aimed to objectively evaluate the effect of timing of decompressive surgery for acute SCI on long-term neurological outcomes.

Methods: We did a pooled analysis of individual patient data derived from four independent, prospective, multicentre data sources, including data from December, 1991, to March, 2017.

Nerve Root Sedimentation Sign: Can It Predict the Success for Surgical Intervention in Patients With Symptomatic Lumbar Spinal Stenosis?

Introduction:  The use of interspinous process devices are less invasive surgical methods designed to manage mild to moderate lumbar spinal stenosis symptoms. Symptomatic relief may not be seen in all patients undergoing this procedure. Magnetic resonance imaging (MRI) parameters have been used to predict the success of clinical outcomes in patients with symptomatic lumbar spinal stenosis for decompressive surgeries.

Gangliosides: Treatment Avenues in Neurodegenerative Disease.

Gangliosides are cell membrane components, most abundantly in the central nervous system (CNS) where they exert among others neuro-protective and -restorative functions. Clinical development of ganglioside replacement therapy for several neurodegenerative diseases was impeded by the BSE crisis in Europe during the 1990s. Nowadays, gangliosides are produced bovine-free and new pre-clinical and clinical data justify a reevaluation of their therapeutic potential in neurodegenerative diseases.

Interspinous Process Decompression Improves Quality of Life in Patients with Lumbar Spinal Stenosis.

Lumbar spinal stenosis has been shown to negatively impact health-related quality of life. Interspinous process decompression (IPD) is a minimally invasive procedure that utilizes a stand-alone spacer to serve as a joint extension blocker to relieve neural compression in patients with spinal stenosis. Using the 5-year results from an FDA randomized controlled trial of IPD, the quality of life in 189 patients treated with the Superion® spacer was evaluated with the SF-12.

Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis.

Background: Lumbar spinal stenosis is the most common indication for spine surgery in older adults. Interspinous process decompression (IPD) using a stand-alone spacer that functions as an extension blocker offers a minimally invasive treatment option for intermittent neurogenic claudication associated with spinal stenosis.

Methods: This study evaluated the 5-year clinical outcomes for IPD (Superion) from a randomized controlled US Food and Drug Administration (FDA) noninferiority trial.

Superion Interspinous Spacer Treatment of Moderate Spinal Stenosis: 4-Year Results.

Objective: To determine 4-year clinical outcomes in patients with moderate lumbar spinal stenosis treated with minimally invasive stand-alone interspinous process decompression using the Superion device.

Methods: The 4-year Superion data were extracted from a randomized, controlled Food and Drug Administration investigational device exemption trial. Patients with intermittent neurogenic claudication relieved with back flexion who failed at least 6 months of nonsurgical management were enrolled.

Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis.

Interspinous process decompression is a minimally invasive implantation procedure employing a stand-alone interspinous spacer that functions as an extension blocker to prevent compression of neural elements without direct surgical removal of tissue adjacent to the nerves. The Superion® spacer is the only FDA approved stand-alone device available in the US. It is also the only spacer approved by the CMS to be implanted in an ambulatory surgery center.

Superion(®) InterSpinous Spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial.

Purpose: This report provides the 3-year clinical outcomes from the randomized, controlled US Food and Drug Administration Investigational Device Exemption trial of the Superion(®) for the treatment of moderate degenerative lumbar spinal stenosis.

Patients And Methods: The Superion(®) was evaluated in the treatment of subjects aged 45 years or older suffering from symptoms of intermittent neurogenic claudication, secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5. Patients were treated between June 2008 and December 2011 at 31 investigational sites.

Stand-alone interspinous spacer versus decompressive laminectomy for treatment of lumbar spinal stenosis.

Objective: To compare the two-year clinical outcomes of a prospective, randomized controlled trial of an FDA-approved interspinous spacer with the compilation of published findings from 19 studies of decompressive laminectomy for the treatment of lumbar spinal stenosis.

Methods: Back and leg pain, Oswestry disability index (ODI), and Zurich Claudication Questionnaire (ZCQ) values were compared between spacer- and laminectomy-treated patients preoperatively and at 12 and 24 months.

Results: Percentage improvements between baseline and 24 months uniformly favored patients treated with the spacer for back pain (65% vs.

Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion.

Study Design: Prospective, multicenter, randomized clinical trial.

Objective: To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single-level degenerative spondylosis between C3-C4 and C7-T1 with or without prior cervical fusion.

Summary Of Background Data: The 2-year results of the PCM Cervical Disc trial have been reported previously.

Superion interspinous process spacer for intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis: two-year results from a randomized controlled FDA-IDE pivotal trial.

Study Design: Prospective, multicenter, randomized, controlled, investigational device exemption noninferiority trial.

Objective: To determine 2-year outcomes in patients with intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis (LSS) who were treated with the Superion interspinous process spacer.

Summary Of Background Data: Interspinous spacers are a less-invasive treatment alternative compared with surgical decompression for patients with LSS unresponsive to conservative care.

Two-year clinical outcomes of a multicenter randomized controlled trial comparing two interspinous spacers for treatment of moderate lumbar spinal stenosis.

Background: Interspinous spacers are a minimally invasive surgical alternative for patients with lumbar spinal stenosis (LSS) unresponsive to conservative care. The purpose of this prospective, multicenter, randomized, controlled trial was to compare 2-year clinical outcomes in patients with moderate LSS treated with the Superion(®) (Experimental) or the X-Stop(®), a FDA-approved interspinous spacer (Control).

Methods: A total of 250 patients with moderate LSS unresponsive to conservative care were randomly allocated to treatment with the Experimental (n = 123) or Control (n = 127) interspinous spacer and followed through 2 years post-treatment.

A prospective, randomized, controlled clinical investigation comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion. 2-year results from the US FDA IDE clinical trial.

Study Design: Prospective, multicenter, randomized Food and Drug Administration approved investigational device exemption clinical trial.

Objective: To evaluate the safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in the treatment of patients with degenerative spondylosis and neurological symptoms at 1 level between C3-C4 and C7-T1.

Summary Of Background Data: Cervical disc arthroplasty in the treatment of symptomatic cervical spondylosis has been studied in other series.

Traumatic thoracic ASIA A examinations and potential for clinical trials.

Study Design: Retrospective review of prospective database.

Objective: To define the variability of neurologic examination and recovery after nonpenetrating complete thoracic spinal cord injuries (American Spinal Injury Association [ASIA] A).

Summary Of Background Data: Neurologic examinations after spinal cord injury (SCI) can be difficult and inconsistent.

Prospective, Randomized, Multicenter FDA IDE Study of CHARITÉ Artificial Disc versus Lumbar Fusion: Effect at 5-year Follow-up of Prior Surgery and Prior Discectomy on Clinical Outcomes Following Lumbar Arthroplasty.

Background: Candidates for spinal arthrodesis or arthroplasty often present with a history of prior surgery such as laminectomy, laminotomy or discectomy. In this study, lumbar arthroplasty patients with prior surgery, and in particular patients with prior discectomy, were evaluated for their clinical outcomes at the 5-year time point.

Methods: Randomized patients from the 5-year CHARITÉ investigational device exemption (IDE) study were divided as follows: 1) fusion prior surgery (excluding prior decompression with fusion) group (FSG); 2) fusion prior discectomy group (FDG); 3) fusion no prior surgery group (FNG); 4) arthroplasty prior surgery group (ASG); 5) arthroplasty prior discectomy group (ADG); and 6) arthroplasty no prior surgery group (ANG).

Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up.

Background Context: The CHARITE artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study. No long-term, randomized, prospective study on the CHARITE disc or any other artificial disc has been published to date.

Purpose: The purpose of this study was to compare the safety and effectiveness at the five-year follow-up time point of lumbar total disc replacement using the CHARITE artificial disc (DePuy Spine, Raynham, MA) with that of anterior lumbar interbody fusion (ALIF) with BAK cages and iliac crest autograft, for the treatment of single-level degenerative disc disease from L4 to S1, unresponsive to nonoperative treatment.

Effect of previous surgery on clinical outcome following 1-level lumbar arthroplasty.

Object: A secondary lumbar surgery at a previously surgically treated level is believed to result in minimal clinical improvement. The clinical results of the CHARITE Investigational Device Exemption (IDE) study were analyzed to assess the effect of previous surgery on clinical outcomes following either total disc replacement with the CHARITE device or anterior lumbar interbody fusion with a BAK cage and iliac crest autograft.

Methods: Patients with prior microdiscectomy, laminectomy, or minimal medial facetectomy were not excluded from enrollment in the CHARITE IDE study.