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The Fabrication and clinical assessment of 3D-printed personalized bone implants for the treatment of eye orbit lesions

Protocol summary

Study aim
Clinical evaluation of 3D-printed implants made of hydroxyapatite and polycaprolactone for the treatment of eye orbit lesions.
Design
It is a non-randomized single-group clinical trial with 500 patients receiving 3D-printed orbit implants enrolling between February 2024 and February 2027 and will be followed for 1 year.
Settings and conduct
A total of 500 patients will receive these implants. The surgical placement of the implants are carried out in a hospital setting under the supervision of a qualified surgeon, with subsequent closure of the skin. Post-surgery, the patient undergoes clinical assessment within 7 to 10 days. At the 6-month mark, a follow-up appointment is scheduled for evaluation of the orbital region, including vision correction if necessary. Based on the doctor's assessment, CT scan images will be taken one-year post-surgery to assess bone regeneration and the integrity of the implants.
Participants/Inclusion and exclusion criteria
Patients who suffer from bone defects in the orbital region of the eye are eligible for the study. Patients with a history of undergoing cancer therapy, diabetes, osteoporosis, tobacco use, challenges with anesthesia administration, and susceptibility to antibiotics are excluded from participating in this research.
Intervention groups
The intervention group is to investigate the effectiveness of 3D-printed biodegradable implants made of polycaprolactone and hydroxyapatite (40% wt), which are placed in patients with bone injuries of the eye orbit due to accidents, osteotomy, or congenital reasons. Implants are placed in the lesion during surgery and after anesthesia, and the skin is sutured after the procedure. These implants are made in collaboration with Adli Tissue Regeneration.
Main outcome variables
Newly formed bone density; the rate of new bone formation; biodegradation rate of the implant; symmetry matching of eyes and orbit region

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220807055633N3
Registration date: 2024-06-03, 1403/03/14
Registration timing: registered_while_recruiting

Last update: 2024-06-03, 1403/03/14
Update count: 0
Registration date
2024-06-03, 1403/03/14
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
recruiting
Funding source
Expected recruitment start date
2024-02-21, 1402/12/02
Expected recruitment end date
2029-03-19, 1407/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Fabrication and clinical assessment of 3D-printed personalized bone implants for the treatment of eye orbit lesions
Public title
Investigation of 3D-printed bone implants in surgeries of eye orbit lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with bone lesions in the eye orbit
Exclusion criteria:
Patients with a history of undergoing cancer therapy Patients with a history of diabetes Patients with a history of osteoporosis Patients with a history of cigarette use Patients with challenges with anesthesia administration Patients with susceptibility to antibiotics
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 500
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2024-02-21, 1402/12/02
Ethics committee reference number
IR.ARI.MUI.REC.1402.308

Health conditions studied

1

Description of health condition studied
Resorbable bone implants for repair of eye orbit lesions
ICD-10 code
Z96.7
ICD-10 code description
Presence of other bone and tendon implants

Primary outcomes

1

Description
Newly formed bone density after implant placement
Timepoint
1 year after implant placement in the body
Method of measurement
Providing CT scan images

2

Description
The rate of new bone formation
Timepoint
1 to 2 years after implant placement in the body
Method of measurement
Providing CT scan images and analyzing with Mimics software

Secondary outcomes

1

Description
Biodegradation rate of the implant
Timepoint
1 year after implant placement in the body
Method of measurement
Providing CT scan images

2

Description
Orbital region and eyes contouring
Timepoint
6 months to 1 year after implant placement in the body
Method of measurement
Clinical observation

Intervention groups

1

Description
For individuals suffering from bone defects in the orbital region of the eye, customized 3D printed implants composed of polycaprolactone and hydroxyapatite (40% wt) are employed in the surgical procedure to address the lesion, and are produced by Adli Tissue Regeneration company.
Category
Treatment - Surgery

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
Isfahan
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
Medical Engineering
Street address
Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3865
Fax
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
Medical Engineering
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3865
Email
ali.poursamar@amt.mui.ac.ir

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
Medical Engineering
Street address
Hezar Jerib Avenue
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3865
Email
ali.poursamar@amt.mui.ac.i

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
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