Wounds and Injuries

All Conditions

Neoplasms

Symptoms and General Pathology

Fractures, Bone

Neoplasm Metastasis

Neoplastic Processes

Patients affected by spinal metastases that are not surgically treated

Extraction of clinical and radiographic data related to patients' history from medical records

Case series review of clinical and radiographic data

Giovanni Barbanti Brodano, MD

Cristiana Griffoni, PhD

Peter Vajkoczy

Aron Lazary

Jorrit-Jan Verlaan

Train-METASTRA is a retrospective study that will be performed in order to collect a large and harmonised amount of clinical and imaging data concerning vertebral metastases, focusing in particular on the risk of fractures. This type of dataset will be created from the medical records of 2000 patients admitted in the last ten years in the four European clinical centers participating in METASTRA project: "COMPUTER-AIDED EFFECTIVE FRACTURE RISK STRATIFICATION OF PATIENTS WITH VERTEBRAL METASTASES FOR PERSONALISED TREATMENT THROUGH ROBUST COMPUTATIONAL MODELS VALIDATED IN CLINICAL SETTINGS", funded by the European Union under the call "HORIZON-HLTH-2022-TOOL-12-two-stage/Computational models for new patient stratification strategies". The project is coordinated by the University of Bologna (UNIBO) (PI prof. Luca Cristofolini) and involves 15 European partners, including Sarl Voisin Consulting Life Sciences VCLS, University of Szeged (Hungary), University of Sheffield (UK) and FrontEndART (Hungary).

This type of dataset is not currently available in the literature and it will be pivotal to the development of the METASTRA computational models for the stratification of the risk of fracture of patients affected by spinal metastases.

Multicentric European Study In Patients With Vertebral Metastases

Retrospective Multicentric European Study In Patients With Vertebral Metastases (Train-Metastra)

The primary objective of the study is to identify the main relevant characteristics to be used for stratifying the patients with vertebral metastases based on their risk of fracture.

The primary objective of the study is to identify the main relevant demographic, clinical and radiographic characteristics to be used for stratifying the patients with vertebral metastases based on their risk of fracture.

To train the data-driven computational models (METASTRA-AI) developed within the project

To inform the physiology-based biomechanical models (METASTRA-VPH) developed within the project

Istituto Ortopedico Rizzoli

Nervous System Diseases

Heart and Blood Diseases

Musculoskeletal Diseases

Mouth and Tooth Diseases

Rare Diseases

Neuralgia

Recurrence

Aneurysm

Brain Diseases

Hydrocephalus

Spinal Diseases

Constriction, Pathologic

Brain Neoplasms

Trigeminal Neuralgia

Spinal Stenosis

Cysts

Spinal Fractures

Spinal Cord Neoplasms

Spinal Curvatures

Central Nervous System Neoplasms

Nervous System Neoplasms

Central Nervous System Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Pain

Neurologic Manifestations

Bone Diseases

Trigeminal Nerve Diseases

Facies

Facial Neuralgia

Facial Nerve Diseases

Mouth Diseases

Stomatognathic Diseases

Cranial Nerve Diseases

Spinal Injuries

Back Injuries

Spinal Cord Diseases

The primary intervention of the Transitional Care Programme (TCP) will be additional patient education, framing of expectations for the hospital course and length of stay, coordinated team preparation for discharge, a dedicated discharge appointment, and a follow up phone call.

Patients are admitted without a pre-determined discharge date. They do not receive a dedicated discharge appointment, and will not receive a follow up phone call 48 hours after discharge.

These patients will receive a pre-admission overview of their surgery, an anticipated discharge date, and a pre-scheduled discharge appointment to set patient expectations for a shorter hospitalization. On the day of discharge, the patient and his or her caregiver will attend an extended discharge appointment with a TCP-trained nurse. Finally, patients will receive a surveillance phone call 48 hours after discharge.

Transitional Care Programme

Alex Alamri, MBBS

Edward McKintosh, FRCS(SN),PhD

Edward McKintosh, FRCS,PhD

Christopher Uff, PhD,FRCS

Faith C Robertson, BS

William B Gormley, MD,MPH,MBA

Amin Elyas, MBBS,FRCS

Edward McKintosh, FRCS(SN) PhD

Readmissions increasingly serve as a metric of hospital performance, inviting quality improvement initiatives in both medicine and surgery. Recently, a readmission reduction program in the United States was associated with significantly shorter length of stay, earlier discharge, and reduced 30-day readmission after elective neurosurgery. These results underscore the importance of patient education and surveillance after hospital discharge, and it would be beneficial to test whether the same approach yields beneficial results in a different health system, the NHS. In this study, the investigators will replicate the Transitional Care Program (TCP) published by Robertson et al.(Journal of Neurosurgery 2017) with the goal of decreasing length of stay, improving discharge efficiency, and reducing readmissions in neurosurgical patients by optimizing patient education and post-discharge surveillance.

Discharge Program Process Abbreviations: AA: administrative assistant; MRN: medical record number; OT: occupational therapy; PT: physical therapy; and TCT = Transitional Care Team.

CLINIC (pre-enrolment)

* Patient has clinic visit with surgeon and is identified for surgery
* Surgeon identifies that the patient is eligible to participate in the program and consents the patient for enrolment.
* Patients will be given a written information sheet on the program, and will have the opportunity to receive the information via email as well.
* Their consent will be obtained in clinic; the use of interpreters will be used for individuals with special communication needs.

AFTER CLINIC

* Once individuals consent to be randomised into the study, their MRN will be given to the TCP nurse, who will randomise the patient into the control or intervention group using a random number generator.
* Patients randomised to the TCP will be given a pre-determined discharge date when they are called to schedule their operation. The anticipated discharge date will be determined by each surgeon's expected length of stay per procedure.
* AA provides brief intro to patient about the discharge pilot, including need for family member to be present to take patient home after appointment is complete. The surgery and discharge appointments are then booked.
* AA sends surgical letter (with anticipated length of stay and discharge appointment date/time) and discharge pilot postcard to patient via email or mail
* AA enters case and discharge information into NSU Discharge Calendar
* Transitional Care Team (TCT) checks NSU Discharge Calendar daily for scheduled cases and discharge appointments

ADMISSION (TCT)

* TCT monitors operating theatre regularly for post-op pilot patients and visits daily
* TCT updates Safety Round white boards with all discharge appointment information
* TCT sends daily dept. email, including PT/OT, with following day's discharge appointment details

ADMISSION (INPATIENT/OUTPATIENT TEAMS)

* Patient is deemed appropriate for impending discharge by neurosurgery team
* TCT updates Safety Rounds white board and discusses discharge checklist with care team.
* Inpatient team completes discharge summary
* Inpatient team completes take-away medication list by 4pm one day prior to discharge appointment
* Inpatient team rationalises the need for further blood tests (as part of standard medical treatment, not for study purposes).
* Inpatient team confirms PT/OT is complete
* Inpatient team completes discharge checklist and puts in letter tray in TCP Nurse office for collection

POST-DISCHARGE APPOINTMENT

* Staff nurse or ward sister discharges patient
* TCT pulls discharge medications from pharmacy for appointments
* Healthcare assistant or staff nurse transports patient to discharge appointment
* Discharge appointment checklist completed by TCT for appointment
* Volunteer transports patient to hospital exit or Discharge Lounge

AFTER POST-DISCHARGE APPOINTMENT

* TCT/volunteer scans signed discharge appointment checklist into medical record
* TCT/volunteer records data in the spreadsheet
* TCT/volunteer shreds checklists
* TCT communicates any outstanding issues to primary teams
* Patient is asked to complete a patient satisfaction survey which will be sent via post and email. A second request will be sent at one week and two weeks post discharge.

FOLLOW-UP PHONE CALLS

* After completion of post-discharge appointments, TCT makes follow-up phone calls
* Call template is completed
* Call template is scanned into medical record
* All outstanding issues will be signed out to the primary teams by the TCT

Outcome measures will be collected through:

Intake forms Longitudinal data collection from hospital medical records and patient satisfaction surveys.

Data collected will be 30-day unplanned hospital re-admissions (to the same institution as the index operation) and length of hospital stay, the latter of which will be evaluated continuously by the number of hours of the initial hospitalisation. Time of discharge (with an early discharge defined as before 12:00 PM) will also be recorded.

Patients will be randomised into two groups: standard of care or Transitional Care Programme (TCP)

All eligible patients will be consented to participate in the study. If they consent, a non-clinician study team member will randomise the patient into the control or intervention arm. Thereafter, all members of the care team will be notified of the patient's allocation in order to deliver the TCP.

Neurosurgical Transitional Care Programme

Transitional Care Services: A Quality and Safety Process Improvement Programme in Neurosurgery

Time from admission until discharge (reported in hours)

Early morning discharge (between 00:00 and 11:59)

Total cost of hospital admission, transitional care programme, and readmission

5-point Likert-scale scores will be analyzed from a single patient satisfaction survey that is provided to the patient at the time of discharge. This survey was reported previously by Robertson et al. (Journal of Neurosurgery, 2017). The patient will have 2 weeks to complete the survey. Scores will assess patient satisfaction with 1 being the least satisfied and 5 being the most satisfied. Scores will be averaged for analysis and reporting.

Brigham and Women's Hospital

Harvard Medical School (HMS and HSDM)

Barts & The London NHS Trust

Blood and Lymph Conditions

Intervertebral Disc Degeneration

Bone Marrow Diseases

Spinal Neoplasms

Bone Neoplasms

Alll patients which were treated with the Ennovate® Cervical system in accordance with the indications given in the instructions for use

The Ennovate® Cervical Spinal System is a posterior stabilization for the cervical and upper-thoracic spine. The implants are used for the posterior monosegmental and multisegmental stabilization of the occipitocervical junction and of the cervical and upper thoracic spine.

posterior stabilization for the cervical spine

Sarah Mattes

Stefan Maenz, Dr.

Felix Kiepe, Dr.

Klaus Röhl, Dr.

Philip Gierer, Prof. Dr.

Gierer, Prof. Dr.

Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications

This clinical study is one of the Post market clinical follow-up measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Cervical system. The study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. It includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in trauma and degenerative disorders.

Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical

Multicenter Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical - a Prospective Study on Total Indications

Pain will be assessed by the patient using the Visual Analogue Scale (VAS) which states "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain".

In order to analyze the quality of life of the patients, the 5-dimension 5-level score of EuroQol Group (EQ-5D-5L) is used. The score is self-completed by the patient. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

The Japanese Orthopaedic Association (JOA) myelopathy score is a disease-specific and physician oriented system that mainly assesses the neurological status of the patient and enables surgeons to compare the changes in the neurological status of the patient before and after certain treatments. However, the JOA score does not include patients' satisfaction, disability, handicaps, or general health (physical and mental health), which can be affected by cervical myelopathy.

The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items to measure patient-reported disability secondary to neck pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation and patients rate their status from 0 (best) to 5 (worst imaginable). Individual item responses are summed to a total score, where 0 points indicate no activity limitations and 50 points indicate complete activity limitation.

After cervical stabilization fusion of the treated segment is aspired in most cases. The fusion status can be determined from radiographs (static or dynamic). Bony fusion can be characterized quantitatively by the fusion rate.

Occurrence of complications potentially associated with the implanted devices can never be fully excluded during spinal surgery. In order to monitor potential complication and to identify so far unknown complications Adverse Events and Serious Adverse Events deemed related to the investigational device are recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multicentric European Study In Patients With Vertebral Metastases	NCT06220071	Spinal Metastas...	Case series rev...	18 Years -	Istituto Ortopedico Rizzoli
Neurosurgical Transitional Care Programme	NCT03593330	Surgery Brain Tumor Brain Tumor, Re... Brain Pathology Spinal Diseases Spinal Stenosis Spinal Fusion Trigeminal Neur... Hydrocephalus Fusion of Spine Aneurysm SPINAL Fracture Chiari; Net Skull Injuries Brain Cancer Brain Metastase... Brain Diseases Brain Lesion Brain Cyst Spinal Curvatur... Spinal Instabil... Spinal Cord Neo...	Transitional Ca...	-	Barts & The London NHS Trust
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical	NCT05296889	Spine Fracture Degenerative Di... Spinal Instabil... Spinal Tumor Degenerative My...	posterior stabi...	18 Years -	Aesculap AG
Neurosurgical Transitional Care Programme	NCT03593330	Surgery Brain Tumor Brain Tumor, Re... Brain Pathology Spinal Diseases Spinal Stenosis Spinal Fusion Trigeminal Neur... Hydrocephalus Fusion of Spine Aneurysm SPINAL Fracture Chiari; Net Skull Injuries Brain Cancer Brain Metastase... Brain Diseases Brain Lesion Brain Cyst Spinal Curvatur... Spinal Instabil... Spinal Cord Neo...	Transitional Ca...	-	Barts & The London NHS Trust
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical	NCT05296889	Spine Fracture Degenerative Di... Spinal Instabil... Spinal Tumor Degenerative My...	posterior stabi...	18 Years -	Aesculap AG

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