Jeremy Reynolds, MD Principal Investigator Clinical Lead for Spinal Surgery at Oxford University Hospitals
Kontakt
Benjamin Bretzinger Kontakt: Phone: +41 79 814 01 48 E-Mail: benjamin.bretzinger@aofoundation.org» Kontaktdaten anzeigen Felix Thomas Kontakt: Phone: +41 79 671 47 98 E-Mail: felix.thomas@aofoundation.org» Kontaktdaten anzeigen
Studienlocations (3 von 19)
Universitaetsklinikum Carl Gustav Carus der Techn. Universitaet - Dresden 1307 Dresden (Sachsen) GermanyRekrutierend» Google-Maps Ansprechpartner: Alexander Disch, PD, MD E-Mail: alexander.disch@uniklinikum-dresden.de» Ansprechpartner anzeigenUniversity of California 90095 Los Angeles United StatesAktiv, nicht rekrutierend» Google-MapsUCSF Medical Center 94134 San Francisco United StatesRekrutierend» Google-Maps Ansprechpartner: Dean Chou, MD E-Mail: Dean.Chou@ucsf.edu» Ansprechpartner anzeigen
Johns Hopkins University School of Medicine 21205 Baltimore United StatesRekrutierend» Google-Maps Ansprechpartner: Chetan Bettegowda, MD E-Mail: cbetteg1@jhmi.edu» Ansprechpartner anzeigenMassachusetts General Hospital 02114 Boston United StatesRekrutierend» Google-Maps Ansprechpartner: John H Shin, MD E-Mail: Shin.John@mgh.harvard.edu» Ansprechpartner anzeigenMayo Clinic 55905 Rochester United StatesRekrutierend» Google-Maps Ansprechpartner: Michelle Clarke, MD E-Mail: Clarke.Michelle@mayo.edu» Ansprechpartner anzeigenMemorial Sloan-Kettering Cancer Center 10065 New York United StatesNoch nicht rekrutierend» Google-Maps Ansprechpartner: Mark Bilsky E-Mail: bilskym@MSKCC.ORG» Ansprechpartner anzeigenMemorial Sloan Kettering Cancer Center 1275 New York United StatesRekrutierend» Google-Maps Ansprechpartner: Ori Barilai, MD E-Mail: barzilao@mskcc.org» Ansprechpartner anzeigenRhode Island Hospital 02903 Providence United StatesRekrutierend» Google-Maps Ansprechpartner: Ziya L. Gokaslan, MD E-Mail: ziya_gokaslan@brown.edu» Ansprechpartner anzeigenThe University of Texas M.D. Anderson Cancer Center 77030 Houston United StatesRekrutierend» Google-Maps Ansprechpartner: Laurence D. Rhines, MD E-Mail: lrhines@mdanderson.org» Ansprechpartner anzeigenUniversity of Queensland, School of Medicine 4000 QLD Brisbane AustraliaSchwebend» Google-MapsVancouver General Hospital and the University of British Columbia V5Z 1M9 Vancouver CanadaRekrutierend» Google-Maps Ansprechpartner: Nicolas Dea, MD E-Mail: nicolas.dea@vch.ca» Ansprechpartner anzeigenToronto Western Hospital M5T 2S8 Toronto CanadaRekrutierend» Google-Maps Ansprechpartner: Yoga Raja Rampersaud, MD, PhD Phone: 416-603-5627 E-Mail: raja.rampersaud@uhn.on.ca» Ansprechpartner anzeigenPeking University 3rd Hospital 100191 Beijing ChinaRekrutierend» Google-Maps Ansprechpartner: Feng Wei, MD E-Mail: mountweifeng@126.com» Ansprechpartner anzeigenNational Center for Spinal Disorders and Buda Health Center 1126 Budapest HungaryRekrutierend» Google-Maps Ansprechpartner: Aron P Lazary, MD E-Mail: aron.lazary@bhc.hu» Ansprechpartner anzeigenIstituto Ortopedico Rizzoli 40136 Bologna ItalyRekrutierend» Google-Maps Ansprechpartner: Alessandro Gasbarrini, MD E-Mail: gasbarrini@me.com» Ansprechpartner anzeigenIRCCS Istituto Ortopedico Galeazzi 20161 Milano ItalyRekrutierend» Google-Maps Ansprechpartner: Alessandro Luzzati, MD E-Mail: alessandroluzzati@gmail.com» Ansprechpartner anzeigenKanazawa Medical University Hospital 920-8641 Kanazawa JapanAbgebrochen» Google-MapsOxford University Hospitals OX3 7HE Oxford United KingdomRekrutierend» Google-Maps Ansprechpartner: Jeremy Reynolds E-Mail: jezreynolds@doctors.org.uk» Ansprechpartner anzeigen
1. Overall survival data (Time Frame - From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years): FU visits will be scheduled and performed according to the local standard of care and at each scheduled visit the patient's survival will be documented. In case a patient misses a scheduled visit it will be assessed if the patient is still alive
2. Local disease recurrence data (Time Frame - From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years): At first prospective treatment and every FU visit, each patient, regardless of which stage they are at in their treatment, will be evaluated for local disease recurrence. Patients that are classified as "non-virgin" will be evaluated for local disease recurrence also at baseline.
3. Perioperative morbidity data (Time Frame - From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years): Complications will be assessed by evaluating the patient's medical files from the time treatment was initiated until the day of follow-up.
Intraoperative complications: (Airway/ventilation; Allergic reaction; Anesthesia related; Bone implant interface failure requiring revision; Cardiac; Cord injury; Dural tear; Hardware malposition requiring revision; Hypotension ; Massive blood loss ; Nerve root injury; Pressure sores; Vascular injury; Visceral injury; Other).
Pre-/post treatment complications: (Cardiac arrest/failure/arrhythmia; Construct failure with loss of correction; Construct failure without loss of correction; CSF leak/meningocele; Deep vein thrombosis; Deep wound infection; Delirium; Dysphagia; Dysphonia; GI bleeding; Hematoma; Myocardial infarction; Neurologic deterioration; Non-union; Pneumonia; Postoperative neuropathic pain; Pressure sores; Pulmonary embolism; Superficial wound infection; Systemic infection; Urinary tract infection; Wound dehiscence; Other)
Secondary outcome:
1. Euroqol EQ-5D-3L or Euroqol EQ-5D-Y (for patients <16y) (Time Frame - From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years): The EuroQOL group developed a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it contains 5 questions and provides a simple descriptive profile and a single index value for health status.
EQ-5D is designed for self-completion by respondents and is ideally suited for use in mailed surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire.
2. Pain Numeric Rating Scale (Time Frame - From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years): It will be assessed for neck, back, leg and arm. The Pain NRS is an 11-point horizontal scale where the end points are the extremes of no pain (0) and pain as bad as it could be, or worst pain (10). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain.
3. SF-36 version 2 (Time Frame - From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years): It is a multipurpose, short-form health survey with 36 questions. It yields an eight-scale profile of scores: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. In addition, two composite scores are constructed using factorial modeling, one for physical health (Physical Composite Score - PCS) and one for mental health (Mental Composite Score - MCS). A scoring algorithm is available using linear T-score transformation that translates scores using population based norms into scores with mean = 50 and standard deviation = 10. The algorithm is available for all 8 subscales as well for the PCS and MCS.
4. Spine Oncology Study Group Outcome Questionnaire (Time Frame - From the date of enrollment until the date of dropout (ie. consent withdrawal, lost-to follow-up or death) which can be up to 25 years): This is a new HRQOL outcome tool which was developed specifically for metastatic spine disease. It is currently available in English and Hungarian. It contains 20 items representing all four domains of the International Classification of Function and Disability. Additionally, there are seven follow-up questions referring to treatment satisfaction. It is made up of five domains: physical function, neural function, pain, mental health, and social function. During the first phase of this registry, patients completed the SOSGOQ version 1.0. The English SOSGOQ version 2.0 was released in January 2018 and will be used
5. Survey on patient expectation (Time Frame - Prior to surgical treatment): A survey on the patient's expectation regarding the surgery. Only applicable for patients that receive surgical treatment.
6. Survey on patient satisfaction (Time Frame - After surgical treatment until the date of dropout (ie. consent withdrawal, lost to follow-up or death) which can be up to 25 years): A survey on the patient's satisfaction post-surgery. Only applicable for patients that receive surgical treatment.
Quelle: ClinicalTrials.gov
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