Symptoms and General Pathology

All Conditions

Wounds and Injuries

Nervous System Diseases

Critical Illness

Brain Injuries

Brain Injuries, Traumatic

Brain Diseases

Central Nervous System Diseases

Craniocerebral Trauma

Trauma, Nervous System

Disease Attributes

Patients treated on the ICU with brain injury

Patients treated on the ICU because of intracranial tumor

Patients treated on the ICU following surgery without brain injury

Patients treated on the ICU without TBI, tumor or surgery

In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.

Blood, cerebrospinal fluid and urine samples

The neurotrophic protein S100B has been promoted as a neuromarker for decades, and to reflect the severity of brain injury. On the other hand, S100B is a tumor marker. The interpretation of its serum levels may be altered by a contribution from extracerebral sources and its renal elimination.

In the present study we investigate the relevance of S100B as a prognostic factor, as well as the correlation with different CT classifications in a large cohort of patients with and without brain injury. Furthermore, we examine whether S100B is elevated in brain tumors.

Patients of the Department of Neurosurgery, University of Erlangen-Nuremberg, undergoing surgery for sellar lesions were prospectively included. The study protocol was approved by the local Ethical Committee. Informed written consent was given by the participants or the next-of-kin in each case. Exclusion criteria comprised of those below 18 years of age, pregnancy and a drug intolerance.

Patients baseline information included age, gender, clinical presentation, and preexisting medical conditions. In four different cohorts of patients, S100B was measured:

1. ICU TBI, patients treated on the ICU with brain injury
2. ICU tumor, patients treated on the ICU because of an intracranial tumor
3. ICU surgery, patients treated on the ICU following surgery without brain injury
4. ICU control, patients treated on the ICU without TBI, tumor or surgery

The performed diagnostic tests included blood, cerebrospinal fluid and urine samples. In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.

Samples were immediately centrifuged for 10min at 1.300xG and 4°C and stored at a temperature of -80°C until the assays were performed. Analysis was performed with commercially available kits on automated immunoanalyzers (LIAISON® Sangtec®100 by chemiluminescence immunoassay, Diasorin). The sensitivity of the assay was 0.02ng/ml.

In all cohorts the clinical status was documented with Glasgow Coma Score (GCS), and the outcome was assessed applying the Glasgow Outcome Score (GOS) or the Karnofsky Status Scale. The radiological work-up included a computed tomography (CT) or a magnetic resonance imaging (MRI). In brain injured patients, the CT was classifiied by the Marshall and Rotterdam Score. Extracranial injuries or surgical procedures were documented

Statistical analysis was performed with SPSS, and p\<0.05 was accepted as significant.

S100B in Intensive Care Patients With and Without Traumatic Brain Injury

S100B in Intensive Care Patients With and Without Traumatic Brain Injury: Implications for Neuromarker Assessment

The Glascow Outcome Scale classifies patients by objective degree of recovery, Minimum 1: death - Maximum 5: good recovery

Karnofsky Performance Status Scale describes patients functional status as a comprehensive 11 point scale correlatig to percentage values ranging from 100% ( no evidence of disease, no symptoms) to 0% ( death)

University of Erlangen-Nürnberg Medical School

Associate Professor

Musculoskeletal Diseases

Intervertebral Disc Degeneration

Spinal Diseases

Bone Diseases

MUST MINI system

Elisa Bonacina, PhD

Jens Lehmberg, Prof Dr

Jens Lehmberg, Prof Med

The goal of this study is to assess the MUST MINI system safety in patient who will undergo a posterior cervical spine fusion intervention. Patients will be invited to partecipate during preoperative visit and follow the postoperative visits according to the standard practice.

Patient who will undergo a posterior cervical spine fusion intervention, will be invited during preoperative visit to take part to the study.

The study is an observational multicentric study with an enrolment period of 12 months with the aim to assess the safety of MUST MINI system.

All adverse events will be collected for all study duration, classified as device and not device related. Screw failure rate is calculated considering screw loosening, breakage, lost-reduction events.

Standard radiological investigations are previewed at preoperative visit, before discharge and at 6 weeks and 12 months follow-up after surgery visits; the risk of any further exposure to radiation other than it's routine use in a diagnostic manner within the follow-up period can be excluded.

A final visit at 12 months level index fusion will be evaluated clinically as well as radiographically, with a confirmation CT scan as per standard of care. Screw placement accuracy will be evaluated during this visit.

A functional cervical x-ray is considered also during last follow-up (12 months after surgery) in order to assess cervical spine functionality.

A Safety Study on Posterior Pedicle Screw System

Prospective Multicentric Clinical Study to Assess Safety of MUST MINI Posterior Cervical System.

mJOA questionnaire, a 18-point investigator-administered scale separately addresses motor dysfunction of the upper extremity (MDUE) and motor dysfunction of the lower extremity (MDLE), sensory loss of the upper extremity, and sphincter dysfunction (SD). Severe myelopathy (0-11), moderate myelopathy (12-14), mild myelopahty (15-17).

NDI questionnaire. Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.

0-4points (0-8%) no disability, 5-14points ( 10 - 28%) mild disability, 15-24points (30-48% ) moderate disability, 25-34points (50- 64%) severe disability, 35-50points (70-100%) complete disability

EQ-5D questionnaire consists of two section, descriptive and a visual analog scale to describe the own health status. The score is calculated by assigning a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and summing these values across the five items, resulting in a score from 5 to 25.

VAS pain scale measure the pain intensity with a scale from 0 ('no pain') to 10 ('pain as bad as it could possibly be').

For each level a CT examination will be performed in order to define if bone fusion is or not. The presence or absence of bridging trabecular bone across the segment can identify is reported.

Sandard functional x-ray is performed in order to measure the segmental range of motion in the lumbar spine during flexion-extension with the purpose of gathering additional data for the diagnosis of instability.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
S100B in Intensive Care Patients With and Without Traumatic Brain Injury	NCT04501315	Tumor Brain Injuries Trauma Injury Critical Illnes... Surgery--Compli...	Blood, cerebros...	18 Years -	University of Erlangen-Nürnberg Medical School
A Safety Study on Posterior Pedicle Screw System	NCT05821920	Degenerative Di... Trauma Injury Tumor	MUST MINI syste...	18 Years -	Medacta International SA

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