Addition of Intra-operative Radiation Therapy (IORT) to conventional kyphoplasty in patients with spinal metastasis to asses the effects of this approach in follow-up period
Design
In this prospective clinical trial, 10 patients with spinal metastasis candidate for Kyphoplasty, will undergo IORT and their clinical, neurological and functional status will be evaluated in pre- and post-operative follow-up periods.
Settings and conduct
This prospective clinical trial will comprise 10 patients diagnosed with spinal metastasis who will be candidates of spinal column Kyphoplasty following application of inclusion and exclusion criteria and will receive radiation during their surgery (IORT) and will be assessed and followed-up in both short and long-term post-operative periods, regarding evaluation of potential complications and neurological status.
Participants/Inclusion and exclusion criteria
It is predicted that 10 patients between 18 to 80 years with confirmed diagnosis of spinal metastasis by radiological and histopathological evaluations will enroll in to this study. Also, cases with previous history of IORT to same involved level, presence of primary bone or neural tissue tumors of spinal column in same desired level, presence of any localized soft tissue infection or systemic infection leading to patient's state deterioration, presence of underlying anatomic disorder of spinal column which can lead to inability of insertion and maintenance of spinal applicators and presence of previous spinal column fractures or osteoporosis will be excluded from the study.
Intervention groups
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.
Main outcome variables
Evaluation of pain; performance ability; neurological status
General information
Reason for update
Acronym
IR-K-IORT
IRCT registration information
IRCT registration number:IRCT20160108025901N1
Registration date:2019-12-12, 1398/09/21
Registration timing:registered_while_recruiting
Last update:2019-12-12, 1398/09/21
Update count:0
Registration date
2019-12-12, 1398/09/21
Registrant information
Name
Amir Nikouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7213
Email address
amirnikouei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-30, 1398/09/09
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
First Experience of Intra-operative Radiation Therapy (IORT) during Kyphoplasty in Patients with Spinal Metastasis in Iran
Public title
Intra-operative Radiation Therapy (IORT) in patients with spinal metastasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of spinal metastasis by radiological evaluation
Confirmed diagnosis of spinal metastasis by histopathological evaluation
Exclusion criteria:
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
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yaman Street, Velenjak, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-12-19, 1396/09/28
Ethics committee reference number
IR.SBMU.MSP.REC.1396.685
Health conditions studied
1
Description of health condition studied
Spinal metastasis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
2
Description
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
3
Description
Neurological status
Timepoint
Pre- and post-operative period
Method of measurement
Neurological examination
4
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.