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IRCT20160108025901N1 IRCT 2019-12-12 Shahid Beheshti University of Medical Sciences Intra-operative Radiation Therapy (IORT) in patients with spinal metastasis IR-K-IORT First Experience of Intra-operative Radiation Therapy (IORT) during Kyphoplasty in Patients with Spinal Metastasis in Iran 2019-11-30 anticipated 10 Complete https://irct.ir/trial/43801 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Spinal metastasis. All of the predicted ten patients with spinal metastasis will be candidates of Kyphoplasty surgical procedure and will receive IORT by individualized applicators with specific dosage based on patient's biomechanic features.. Yes - There is a plan to make this available What will be shared: All of the data will be sharedfollowing unidentification of subjects. When: Initiation of data access following publication is based upon publishing journal's policies. To whom: All of the researchers of scientific assemblies Conditions: To evaluate the results of this novel therapeutic approach Where to obtain: Through e-mail How to obtain: By send an official request to department of research of university following relevant approvals Comments:
public Amir Nikouei
Shohada Tajrish Hospital, Shahrdari St, Tajrish Sq
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8001 amirnikouei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Afsoun Seddighi
Shohada Tajrish Hospital, Shahrdari St, Tajrish Sq
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8001 afsoun.seddighi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Confirmed diagnosis of spinal metastasis by radiological evaluation Confirmed diagnosis of spinal metastasis by histopathological evaluation 18 years 80 years Both Previous history of Intra-operative Radiation therapy (IORT) to the same involved location Presence of primary bone tumors or neural tissue tumors of spine Presence of any local soft tissue infection or systemic infection Presence of underlying anatomic disorder of spinal column Treatment - Surgery All of the predicted ten patients with spinal metastasis will be candidates of Kyphoplasty surgical procedure and will receive IORT by individualized applicators with specific dosage based on patient's biomechanic features. Pain. Timepoint: Pre-operative period; 2nd week, 1st month, 2nd month and 6 month post-operative period. Method of measurement: Visual Assessment Score (VAS) questionnaire. Individual's ability of performance. Timepoint: Pre-operative period; 2nd week, 1st month, 2nd month and 6 month post-operative period. Method of measurement: Karnofsky Performance Scale (KPS) questionnaire. Neurological status. Timepoint: Pre- and post-operative period. Method of measurement: Neurological examination. Assessment of patient's disability. Timepoint: Pre-operative period; 2nd week, 1st month, 2nd month and 6 month post-operative period. Method of measurement: Oswestry Disability Index (ODI) questionnaire. Shahid Beheshti University of Medical Sciences Approved 2017-12-19 Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Yaman Street, Velenjak, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)