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Assessing the effectiveness of Trans-catheter Arterial Micro Embolization (TAME) in patients with severe knee osteoarthritis

Protocol summary

Study aim
The main objectives: Evaluation of the effectiveness of TAME treatment in the patients with severe osteoarthritis of the knee Sub-objectives: determination of mean age, gender and BMI distribution, duration of pain, Kellgren and Lawrence classification (KL), pain intensity (before, one, three and 6 months after treatment) in patients with sever knee osteoarthritis referred for TAME treatment
Design
single-blinded before-after clinical trial on 30 patients
Settings and conduct
After local anesthesia and injection of 2000 units of heparin, angiography will be performed in the genicular, patellar and tibial arteries. The patient will be asked about the location of the pain, and if the site of pain matches a site with abnormal staining, embolization will be done using 2 units of polyvinyl alcohol 355/500,following pain severity will be measured based on VAS from 1-10. The data analyzer is blind to clinical outcome.
Participants/Inclusion and exclusion criteria
inclusion:severe osteoarthritis (KL grade 4) without age and sex limitation . Receive at least 3 months of outpatient treatments including NSAIDs, opioids and intra-articular hyaluronic acid injection and physiotherapy (muscle strengthening) without improvement. surgery contraindication due to medical conditions (i.e cardiovascular disease). exclusion: malignancy, local infection, rheumatoid arthritis, history of knee surgery, advanced atherosclerosis.
Intervention groups
before-after clinical trial on the effect of TAME on patients with severe knee joint osteoarthritis
Main outcome variables
Studies have not shown major complications such as osteonecrosis, septic arthritis, or cases lead to hospitalization. Minor complications: Erythema at the site of embolization (most common 11%), hematoma at the puncture site (10%), paresthesia (1%) and fever (about 0.5%)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140712018457N5
Registration date: 2022-05-10, 1401/02/20
Registration timing: prospective

Last update: 2022-05-10, 1401/02/20
Update count: 0
Registration date
2022-05-10, 1401/02/20
Registrant information
Name
Hossein Ghanaati
Name of organization / entity
Advanced Diagnostic and Interventional Radiology Research Center (ADIR), Tehran University of Medica
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1516
Email address
ghenaati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effectiveness of Trans-catheter Arterial Micro Embolization (TAME) in patients with severe knee osteoarthritis
Public title
Effectiveness of Trans-catheter Arterial Micro Embolization (TAME) in severe knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe osteoarthritis on examination (KL grade 4) without age and sex restrictions referred by orthopedist Receiving outpatient treatment including NSAIDs, Opioids and intra-articular Hyaluronic Acid injections and physiotherapy for at least 3 months without significant improvement Contraindication for surgery regarding medical conditions such as cardiovascular diseases
Exclusion criteria:
Malignancy, local infection, Rheumatoid Arthritis History of knee surgery Advanced (high grade) Atherosclerosis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the data coding, the data analyzer is unaware of the patient's final clinical outcome and angiography (single blinded)
Placebo
Not used
Assignment
Single
Other design features
Dear Head of Clinical Trial Registration, considering we are waiting to receive the IRCT code before starting the study, we will start data gathering from late may 2022, best regards.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Imam Khomeini Hospital Complex
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-02-05, 1400/11/16
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.414

Health conditions studied

1

Description of health condition studied
Patients with severe knee Osteoarthritis (Kellgren and Lawrence classification / KL grade 4)
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Knee pain
Timepoint
Before the intervention and at one ,three and 6 months following procedure
Method of measurement
Visual Analogue Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients with severe knee osteoarthritis (KL grade 4)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Hossein Ghanaati
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1579
Email
ghanaati@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Ghanaanti
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1579
Email
ghanaati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Alborzi
Position
Research assistant, General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
66581579 021
Email
mahsaalborzi94@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Alborzi
Position
General practitioner, Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1579
Email
mahsaalborzi94@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Ghanaati
Position
Professor of radiology
Latest degree
Subspecialist
Other areas of specialty/work
Radiology
Street address
Kevarz blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1579
Email
ghanaati@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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