Clinical evaluation of hydroxyapatite and polycaprolactone implants prepared via 3D printing method for craniofacial surgery applications
Design
It is a non randomized single group clinical trial with 7 patients receiving 3D printed craniofacial implants enrolling between April 2022 and February 2023, and will be followed for six months.
Settings and conduct
The prepared implants will be used in 7 patients. After implant placement and fixation, the skin will be sutured. In 7 to 10 days after surgery, a clinical evaluation of the patient will be performed. In 3 and 6 months after surgery, CT scan images will be provided to examine the bone regeneration and implant degradation ratio.
Participants/Inclusion and exclusion criteria
Patients over 6 years old who suffer from craniofacial defects and the use of plates in surgery cannot correct the shape of the bone. Exclusion criteria: Having an underlying disease, including allergies.
Intervention groups
The intervention group is investigating the effectiveness and durability of 3D printed implants made of polycaprolactone and hydroxyapatite (40% wt). These implants are intended for trauma patients or patients with natural birth defects with bone deformities in the skull and face area. Implants will be administered during surgery after general anesthesia. The implants are prepared in collaboration with Adli Tissue Regeneration company.
Main outcome variables
Newly formed bone density; the rate of new bone formation; biodegradation rate of the implant; patient sensitivity to ambient temperature changes;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220807055633N1
Registration date:2022-09-16, 1401/06/25
Registration timing:registered_while_recruiting
Last update:2022-09-16, 1401/06/25
Update count:0
Registration date
2022-09-16, 1401/06/25
Registrant information
Name
Seyed Ali Poursamar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3865
Email address
ali.poursamar@amt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-31, 1401/05/09
Expected recruitment end date
2023-01-29, 1401/11/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical study of patient-specific bone implant prepared via 3D printing method for craniofacial surgery applications
Public title
Evaluation of 3D printed bone implant in skull and the face surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who have skull and face defects and the use of plates in surgery cannot correct the shape of the bone.
Exclusion criteria:
Having an underlying disease, including allergies
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
7
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 Esfahan University of Medical Sciences
Street address
Hezar Jerib Avenue
City
esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-07-31, 1401/05/09
Ethics committee reference number
IR.ARI.MUI.REC.1401.132
Health conditions studied
1
Description of health condition studied
Absorbable bone implants to correct craniofacial abnormalities
ICD-10 code
Z96.7
ICD-10 code description
Presence of other bone and tendon implants
Primary outcomes
1
Description
New bone formation
Timepoint
3 and 6 months after implant placement
Method of measurement
Providing CT scan images
Secondary outcomes
1
Description
biodegradation rate of the implant
Timepoint
3 and 6 months after implant placement
Method of measurement
Providing CT scan images
Intervention groups
1
Description
Intervention group: Personalized 3D printed biodegradable implants comprised of polycaprolactone and hydroxyapatite (40% Wt) made by Adli Tissue Regeneration company are utilized during surgery for patients who suffer from bone abnormalities in the skull and face.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Seyed Ali Poursamar
Street address
Isfahan University of Medical Sciences, Hezarjarib Ave
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3865
Email
ali.poursamar@amt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Street address
Isfahan University of Medical Sciences , Hezarjarib Ave
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Ali Poursamar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3865
Email
ali.poursamar@amt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Ali Poursamar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3865
Email
ali.poursamar@amt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Ali Poursamar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3865
Email
ali.poursamar@amt.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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