Wounds and Injuries

All Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Neoplasms

Nervous System Diseases

Constriction, Pathologic

Intervertebral Disc Degeneration

Spondylolisthesis

Spinal Stenosis

Pseudarthrosis

Spinal Cord Neoplasms

Spinal Neoplasms

Spinal Diseases

Bone Diseases

Spondylolysis

Spondylosis

Central Nervous System Neoplasms

Nervous System Neoplasms

Spinal Cord Diseases

Central Nervous System Diseases

Bone Neoplasms

Fractures, Bone

Fractures, Ununited

The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.

NEO Pedicle Screw System™

Neo Cage System™ is intended to be used with bone graft material to facilitate interbody fusion and to be used with the NEO Pedicle Screw System™

Neo Cage System™

David C Noriega, PhD, MD

Yasser Abdalla, MD

The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.

PMCF Neo Pedicle Screw and Cage Systems

Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study

Clinical outcome in function as measured by the 100 point Oswestry Disability Index (ODI). Zero is equated with no disability and 100 is the maximum disability possible.

Defined as posterior movement of the cage past the posterior wall of the vertebral body.

A radiolucent zone, \>1mm, surrounding the pedicle screw seen in radiograhs

ConfinisCPM

Neo Medical SA

Diseases and Abnormalities at or Before Birth

Congenital Abnormalities

Patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).

The study will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware). Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws.

1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).

Aviator Anterior Cervical Plating System

Eeric Truumees, MD

The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery. Specifically, the study aims to collect the data for ACDF model utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).

This is a prospective study with the intent to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery. At the time a patient is scheduled for surgery, the patient's chart will be evaluated for inclusion/exclusion criteria. If a patient meets the criteria for the study, the study will be explained to the patient and consent obtained.

Investigators will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware) will be utilized.

Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws.

Study Outcomes:

* Radiological assessment (cervical spine x-ray and if needed, computed tomography (CT) at 1 year follow up)of fusion as the primary endpoint
* Arthrodesis rates assessed using CT (1 year follow up, if needed) and Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays pre-operative (pre-op), post-operatively (post-op) 2\~4 weeks (10\~34 days post op), 3 months (83\~97 days post-op), 6 months (173\~187 days post-op) and 1 year post-op (351\~379 days post op, primary data point outcome)
* Revision rates
* Outcome scores: Visual Analog Scale (VAS) and Neck Disability Index (NDI) pre-op, post-op 2\~ 4weeks, 3 months, 6 months and 1 year.

The null hypothesis is that in ACDF model, the clinical and radiographic outcomes of utilizing BIO4 bone matrix with Bio AVS Cervical Allograft are equivalent to historical high level published data of similar product (Data reported in Meta-analysis ACDF obtained from FDA disc arthroplasty trials).

BIO4 Clinical Case Study: Cervical Spine

Clinical and Radiographic Outcomes of BIO4 Bone Matrix in Patients Undergoing 1 or 2-Level Anterior Cervical Discectomy and Fusion Surgery

This will be used to monitor the fusion status at 1 year post-op. The fusion states was reported as the number of patients who fused. If fused, then we say "Yes". We counted the number of patients who fused. If all 20 patients fused then we said there were 20 "yes".

Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. We counted the number of patients who developed arthrodesis. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.

As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery

Patient reported VAS will be collected at different time intervals. The revision rate was described as the number of patients who had to undergo revision post index surgery. VAS: 0-10 (0=better, 10=worst)

Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)

Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)

Patient reported NDI will be collected at different time intervals NDI: 0-100 (0=better, 100=worst)

Patient reported NDI will be collected at different time intervals. NSI: 0-100 (0=better, 100=worst)

Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.

Seton Healthcare Family

We reviewed mortality in all our 20 patients

BIO4 Treatment

Treatment group consisted of patient undergoing ACDF using BIO4

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Visual Analog Scale

Neck Disability Index

Devender Singh, Research Scientist

Radiological Assessment : Fusion Status

Arthrodesis Rates

Revision Rates (if Any)

Participants were treated as per the protocol.

Overall Study

Spinal Curvatures

Pedicle screw system

The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw System in the lumbar spine.

Safety and Efficacy of the CarboFix Pedicle Screw System

CarboFix Pedicle Screw System

CarboFix Orthopedics Ltd.

Infections

Recurrence

Intervertebral Disc Displacement

Hernia

Neoplasm Metastasis

Discitis

Pathological Conditions, Anatomical

Spondylitis

Spondylarthritis

Communicable Diseases

Bone Diseases, Infectious

This arm will comprise all patients that receive transpedicular instrumentation by use of a robotic guidance system (SpineAssist or Renaissance, Mazor Robotics, Ltd., Caesarea, Israel or ROSA Spine, Medtech, Montpellier, France).

This arm will comprise all patients that receive transpedicular instrumentation by use of navigation (computer assistance using CT, O-arm or 3D-fluoroscopic imaging).

This arm will comprise all patients that receive transpedicular instrumentation by use of the conventional freehand technique.

Transpedicular screw placement and instrumentation

Transpedicular Instrumentation

Victor E Staartjes, BMed

Marc L Schröder, MD, PhD

Pierre-Pascal Girod, MD

Nikolaus Kögl, MD, MSc

Michel Lefranc, MD, PhD

Aymeric Amelot, MD

Yu-Mi Ryang, MD

Farman Hedayat, MD

Sophie Urbanski

Christoph Bettag, MD

Bawarjan Schatlo, MD

Sandro M Krieg, MD, MBA

Carsten G Schneekloth, MD

Mike Abu Saris, MD

Jasper FC Wolfs, MD

Enrico Tessitore, MD

Duccio Boscherini, MD

Paulien M van Kampen, PhD

In a multinational prospective study, preoperative, intraoperative, perioperative and follow-up data on patients receiving thoracolumbar pedicle screw placement for degenerative disease or infections or tumors will be collected. The three arms consist of robot-guided (RG), navigated (NV), or freehand (FH) screw insertion.

Introduction A decade ago, minimally invasive surgery (MIS) was considered a promising development in spine surgery, yet the value of the pioneering technologies was questionable. With the growing number of experienced MIS surgeons, the influx of evidence in favour of MIS is rapidly increasing. This makes a compelling argument towards MIS offering distinct clinical benefits over open approaches in terms of blood loss, length of stay, rehabilitation, cost-effectiveness and perioperative patient comfort. Due to the limited or inexistent line-of-sight in MIS procedures, surgeons need to rely on imaging, navigation, and guidance technologies to operate in a safe and efficient manner. Therefore, a plethora of new and ever improving navigational systems have been developed. These systems allow a consistent level of safety and accuracy, on par with results achieved by very experienced free hand surgeons, with a reasonably short learning curve. Computer-based navigation systems were first introduced to spine surgery in 1995 and while they have been long established as standards in certain cranial procedures, they have not been similarly adopted in spine surgery.

Designed to overcome some of the limitations of navigation-based technologies, robot-guided surgery has become commercially available to surgeons worldwide, like SpineAssist® (Mazor Robotics Ltd. Caesarea, Israel) and the recently launched ROSA™ Spine (Zimmer-Biomet, Warsaw, Indiana, USA). These systems are rapidly challenging the gold standards. SpineAssist®, and its upgraded version, the Renaissance®, provides a stable drilling platform and restricts the surgeon's natural full range of motion to 2 degrees of freedom (up/down motion and yaw in the cannula). The system's guidance unit moves into the trajectory based on exact preoperative planning of pedicle screws, while accounting for changes in intervertebral relationships such as due to distraction, cage insertion or changes between the supine patient position in the preoperative CT and the prone patient on the operating table. Published evidence on robot-guided screw placement has demonstrated high levels of accuracy with most reports ranging around 98% of screws placed within the pedicle or with a cortical encroachment of less than 2 mm.4 Although the reliability and accuracy of robot-guided spine surgery have been established, the actual benefits for the patient in terms of clinical outcomes and revision surgeries remain unknown. We have recently conducted cohort studies that showed some evidence that robotic guidance lowers the rate of intraoperative screw revisions and implant related reoperations compared to free hand procedures, while achieving comparable clinical outcomes. We now want to assess these factors, among others, on a higher level of evidence. We aim to conduct a prospective, multicenter, multinational controlled trial comparing clinical and patient reported outcomes of robotic guided (RG) pedicle screw placement vs. navigated (NV) vs. free hand (FH) pedicle screw placement using pooled data from three centers.

Study Design The European Robotic Spinal Instrumentation (EUROSPIN) study is a prospective, international, multicentre, pragmatic, open-label, non-randomized controlled trial comparing the effectiveness of three techniques for pedicle screw instrumentation, namely RG, NV (CT-, O-Arm, or 3DFL-based), and FH. Following the baseline evaluation, patients will receive one of the three treatments, and will subsequently be followed up for 24 months (Figure 1). The primary analysis will be conducted using the 12-month data.

Sample Size Calculation It was determined that, to detect an intergroup difference of 5% in the primary endpoint, 205 patients are required per group to achieve a power of 1 - beta = 0.8 at alpha = 0.05. The incidence rates were based on the published literature, with an approximated incidence rate of the primary endpoint of 0% for the intervention and 5% for the control group. Because the study protocol is in line with the normal clinical follow-up of most centers, a low dropout rate is expected. This led to a minimum total sample size of 615 patients.

Monitoring An epidemiologist from the sponsor institution will organize an initiation monitor visit at every participating center before starting recruitment. This monitor visit will check whether all study staff are properly trained and the delegation of tasks are well documented (complete Investigator Site File, training and delegation logs). An additional audit will be carried out at 6 months after initiation of recruitment to check whether source documentation and eCRF documentation is similar. Throughout the entire study additional queries by the monitor are send to the investigator in the data capturing system to ensure proper data capturing.

The European Robotic Spinal Instrumentation (EUROSPIN) Study

The European Robotic Spinal Instrumentation (EUROSPIN) Study: A European Prospective Multicenter Multinational Pragmatic Trial on Robot-guided Versus Navigated Versus Freehand Pedicle Screw Fixation

Frequency of use of analgetics (daily/weekly/not regularly)

Satisfaction with symptoms (satisfied/neutral/dissatisfied)

Working status (able to work/unable to work)

We defined the primary endpoint as required revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year.

Revision or redirection of a placed screw during the same general anesthesia session

Length of Hospital Stay in days (Defined as from admission to discharge, during the hospital stay in which the primary surgery was carried out)

Radiation Dose as DAP (Dose Area Product, cGy cm2)

Need for blood transfusion during the hospital stay (Defined as from admission to discharge, during the hospital stay in which the primary surgery was carried out)

EQ-5D-3L (Health-related quality of life) EuroQOL-five dimensions 3-level version measures health-related quality of life.

The scale is subdivided into an index, ranging from 0 to 1 and normalized to population-specific values, and a "thermometer" or visual analogue scale, ranging from 0 to 100.

The two subscores are not combined towards a single score. Higher values represent a better health-related quality of life in both subscores.

Numeric Rating Scale (NRS) of back pain severity The scale ranges from 0 to 10. Only integers are available to choose from. Higher values represent a higher amount of pain. There are no subscales.

Numeric Rating Scale (NRS) of leg pain severity The scale ranges from 0 to 10. Only integers are available to choose from. Higher values represent a higher amount of pain. There are no subscales.

Oswestry Disability Index (ODI) for functional impairment

Marc Schröder

Head of Department

Spinal Fractures

Spinal Injuries

Back Injuries

Posterior osteosynthesis of the cervical and upper thoracic spine

PASS OCT® Spinal System

Stephane Fuentes, MD

Prospective, multicenter non comparative and observational study (post-market clinical follow-up).

Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.

The inclusion period will be 12 months and the follow-up 24 months

The primary endpoint is to evaluate the safety of the PASS OCT® system.

The secondary endpoints are to analyze the efficacy of the system with several point of view:

* The quality of fusion and the time of fusion through X rays
* the pain with VAS
* the quality of life thanks to questionnaires: NDI (Neck Disability Index) and JOA for myelopathy
* the daily of the patient: return to work, sport
* the surgeon satisfaction.

PASS OCT® Post-market Clinical Follow-up

Evaluation of the Efficacy and Safety of the Cervical Posterior Fixation System PASS OCT®

To assess quality of life through mJOA scoring system

To assess pain using visual analogue scale

Medicrea International

patents in this arm will be implanted with Johnson\&Johnson Medical Suzhou made Spine Fusion System.

patents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage .

interventional device is Spine Fusion System that is manufactured by Johnson \& Johnson Medical Suzhou Ltd.

Johnson&Johnson Medical Suzhou made Spine Fusion System

Comparator in this study is active comparator.

Imported EXPEDIUM screws and OPAL cage

Wei Tian

The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.

This study is a prospective, multicenter, randomized, comparative, non-inferiority study comparing the change of Japanese Orthopaedic Association Score from baseline at postoperative 24 weeks for patients implanted with local made Spine Fusion System versus imported products.

A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery

A Prospective, Multicenter, Randomized, Open-label, Controlled Study to Evaluate the Safety and Efficacy of a Spine Fusion System in Vertebral Body Fusion Surgery

Fixation stability should be measured based on translational motion and angular motion which is demonstrated on X-Ray examination (A/P lateral, Flexion and extension).

would healing are classified as 3 classes. (Class I, Class II, Class III)

Johnson & Johnson Medical (Suzhou) Ltd.

Scoliosis

Philips Intelivue MP70 monitor (Intellivue MP70, Philips medical Systems, Suresnes, France) -a radial arterial cannula is inserted and arterial pressure waveforms are monitored through Philips Intelivue MP70 monitor. In the monitor, PPVauto is displayed in real-time. It is based on automatic detection algorithms, kernel smoothing, and rank-order filters.

Philips Intelivue MP70 monitor

PVI is the measure of the dynamic changes in the Perfusion Index (PI) that occur during one or more complete respiratory cycles. A rainbow Pulse CO-Oximetry sensor is attached to the patient's finger and the PVI is displayed in real-time on the Root monitor.

Pleth Variability Index (PVI)

Appropriate fluid management is an important part of anesthesia in patients undergoing surgery, and several dynamic indices have been suggested to have high predictability for fluid responsiveness in patients receiving mechanical ventilation. Among various surgical positions, the prone position is known to cause unique physiologic and hemodynamic changes and affect the predictability and cut-off values of dynamic indices for fluid responsiveness. A previous study reported that pulse pressure variation (PPV) and corrected flow time were able to predict fluid responsiveness with relatively high accuracy in patients undergoing spine surgery in the prone position using a Wilson frame. However, the Jackson frame is known to have less effects on the cardiovascular system compared to the Wilson frame, and therefore may be physiologically more appropriate in patients undergoing surgery in the prone position. The pleth variability index (PVI) is a dynamic index that can be monitored non-invasively in patients under mechanical ventilation. The present study aims evaluate the validity of PPV and pleth variability index (PVI) as predictors of fluid responsiveness in the supine and prone positions in patients undergoing posterior lumbar spinal fusion using the Jackson table.

Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table

Fluid responsiveness predictability of FTc and PVI in patients undergoing posterior lumbar fusion in the prone position by using the Jackson frame by calculating area under the curve of the ROC curve.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PMCF Neo Pedicle Screw and Cage Systems	NCT03956537	Degenerative Di... Spondylolisthes... Spinal Stenosis Spinal Tumor Trauma Pseudoarthrosis...	NEO Pedicle Scr... Neo Cage System...	18 Years -	Neo Medical SA
BIO4 Clinical Case Study: Cervical Spine	NCT03077204	Degenerative Di... Trauma (Includi... Spondylolisthes...	1 or 2-Level AC... Aviator Anterio...	19 Years -	Seton Healthcare Family
BIO4 Clinical Case Study: Cervical Spine	NCT03077204	Degenerative Di... Trauma (Includi... Spondylolisthes...	1 or 2-Level AC... Aviator Anterio...	19 Years -	Seton Healthcare Family
Safety and Efficacy of the CarboFix Pedicle Screw System	NCT02039232	Degenerative Di... Spondylolisthes... Spinal Stenosis Spinal Curvatur... Tumor	Pedicle screw s...	18 Years -	CarboFix Orthopedics Ltd.
The European Robotic Spinal Instrumentation (EUROSPIN) Study	NCT03398915	Degenerative Di... Spondylolisthes... Spinal Stenosis Recurrent Disc ... Spondylodiskiti... Spinal Tumor Spinal Metastas...	Transpedicular ...	18 Years -	Bergman Clinics
PASS OCT® Post-market Clinical Follow-up	NCT02931279	Intervertebral ... Spondylolisthes... Spinal Stenosis Spinal Neoplasm... Spinal Fracture...	PASS OCT® Spina...	18 Years -	Medicrea International
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery	NCT02252185	Disc Degenerati... Spondylolisthes... Spinal Fracture Spinal Deformit... Spinal Stenosis Spinal Tumor	Johnson&Johnson... Imported EXPEDI...	20 Years - 70 Years	Johnson & Johnson Medical (Suzhou) Ltd.
Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table	NCT02826889	Elective Poster... Spondylolisthes... Spinal Fracture... Scoliosis or Tu...	Philips Inteliv... Pleth Variabili...	19 Years - 75 Years	Yonsei University
Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table	NCT02826889	Elective Poster... Spondylolisthes... Spinal Fracture... Scoliosis or Tu...	Philips Inteliv... Pleth Variabili...	19 Years - 75 Years	Yonsei University

Spots Global Cancer Trial Database for spondylolisthesis