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Clinical trial of a new silicone mold for dynamic spacer production during knee surgery: a pilot clinical trial study

Protocol summary

Study aim
Clinical evaluation of a new silicone mold for producing dynamic spacers during knee surgery
Design
The clinical trial has a control group and a parallel group that is double-blind and non-randomized and the patients are matched. The patients are followed up for one year after the operation, and the range of motion of the knee, the level of function and diagnostic biomarkers of infection are measured in the time intervals of 1 month, 3 months, 6 months and 1 year after the operation.
Settings and conduct
The study is conducted in the hospitals of Bojnurd, the patients are divided into two groups, these groups are matched in terms of age, sex, weight and co-morbidities. The study is double-blind, and a person who does not know the type of spacer used for the patient will perform examinations and measurement of variables .
Participants/Inclusion and exclusion criteria
Entry criteria: patients with artificial joint infection. The diagnostic criteria for current knee infection for inclusion in this study are one or more of the following: aspiration of infectious synovial fluid (determined by differential count of the number of white blood cells and the percentage of polymorphonuclear leukocytes), isolation of organism(s) from synovial fluid , presence of a draining sinus, or MRI evidence of a septic arthritis with osteomyelitis. Exit criteria: None
Intervention groups
The patients are divided into two groups, one receives spacers produced manually, these spacers are made manually from bone cement and antibiotics. And the other group receives the spacers that were produced with a mold, antibiotic cement will be poured into this device and after forming, it will be placed in the knee space during surgery.
Main outcome variables
physical function and life quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191111045400N2
Registration date: 2023-07-12, 1402/04/21
Registration timing: prospective

Last update: 2023-07-12, 1402/04/21
Update count: 0
Registration date
2023-07-12, 1402/04/21
Registrant information
Name
Mohammad Amin Younesieh Heravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7182
Email address
a.younessi7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of a new silicone mold for dynamic spacer production during knee surgery: a pilot clinical trial study
Public title
Clinical trial of a new silicone mold for dynamic spacer production during knee surgery: a pilot clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aspiration of infectious synovial fluid from patient (determined by differential count of the number of white blood cells and the percentage of polymorphonuclear leukocytes) isolation of organism(s) from synovial Fluid of patient presence of a draining sinus MRI evidence of a septic arthritis with osteomyelitis
Exclusion criteria:
polyarticular joint involvement
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
Sample size
Target sample size: 7
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
A person who does not know the type of spacer used for the patient will perform examinations and measurement of variables.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
Daneshgah Ave, Imam Ali hospilat
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Approval date
2023-07-05, 1402/04/14
Ethics committee reference number
IR.NKUMS.REC.1402.056

Health conditions studied

1

Description of health condition studied
Prosthetic Joint Infection
ICD-10 code
T84.5
ICD-10 code description
Infection and inflammatory reaction due to internal joint prosthesis

Primary outcomes

1

Description
physical function
Timepoint
1 month, 3 months, 6 months and one year after surgery
Method of measurement
They are scored through the WOMAC Score questionnaire and the Oxford Knee Score questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The group that has spacers that were produced with a mold, In order to use this device in surgery, after sterilization, antibiotic cement is poured into it and after forming, it is placed in the knee space during surgery.
Category
Treatment - Surgery

2

Description
Control group: The group that has manually produced spacers, usually the surgeon makes these spacers manually from bone cement and this bone cement is impregnated with antibiotics.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali bojnurd Hospital
Full name of responsible person
Dr Reza Ganji
Street address
Daneshghah Ave, Imam Ali Hospital
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3151 1423
Email
a.younessi7@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr Bibak
Street address
Daneshghah Ave, Imam Ali Hospital
City
bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3151 1423
Email
a.younessi7@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd University of Medical Sciences
Proportion provided by this source
100
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
Bojnourd University of Medical Sciences
Full name of responsible person
Mohamad Aamin Younessi
Position
consultant
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Daneshgah Ave, Imam Ali Hospital
City
bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3151 1423
Email
a.younessi7@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mohamad Amin Younessi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Daneshgah ave. Imam Ali Hospital
City
bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3151 1423
Email
a.younessi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mohammad Amin Younessi Heravi
Position
Asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Daneshgah ave.North Khorasan University of Medical
City
bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 7182
Email
a.younessi7@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only research results can be shared
When the data will become available and for how long
beggining of year 2024
To whom data/document is available
just for researchers
Under which criteria data/document could be used
no conditions required
From where data/document is obtainable
to the phone number inserted
What processes are involved for a request to access data/document
almost one week
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