UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054401 |
|---|---|
| Receipt number | R000062143 |
| Scientific Title | Pelvic osteotomy using a 3D printed patient-specific surgical guide |
| Date of disclosure of the study information | 2024/05/15 |
| Last modified on | 2025/11/17 07:22:45 |
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Basic information
Public title
Pelvic osteotomy using a 3D printed patient-specific surgical guide
Acronym
Pelvic osteotomy using a 3D printed patient-specific surgical guide
Scientific Title
Pelvic osteotomy using a 3D printed patient-specific surgical guide
Scientific Title:Acronym
Pelvic osteotomy using a 3D printed patient-specific surgical guide
Region
| Japan |
Condition
Condition
Acetabular dysplasia of the hip
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To create a patient-specific surgical guide using a 3D printer and use it as an adjunct to acetabular rotational osteotomy for acetabular hypoplasia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surgery time, blood loss, time required for fluoroscopy, radiographic parameters
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A patient-specific surgical guide will be created using a 3D printer based on CT and MRI data performed as pre-operative examinations. The osteotomy area is exposed through normal development for acetabular rotational osteotomy, and the osteotomy guide is applied directly to the bone from the inside of the pelvis. The guide is fixed with Kirschner steel wire, and the pelvic osteotomy is performed with a chisel using the guide as a reference. The material used in 3D printers is PLA (polylactic acid), which is a highly safe substance registered with the U.S. Food and Drug Administration (FDA). Additionally, screws made from PLA are already being used as medical devices for fixing bone fractures. Nylon 12 is also used as an osteotomy guide for knee replacement surgery, and there are no safety concerns. Sterilize the device before surgery and use a guide to perform the surgery.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing pelvic osteotomy for acetabular dysplasia
Key exclusion criteria
Other than patients undergoing pelvic osteotomy for acetabular dysplasia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hidetatstu |
| Middle name | |
| Last name | Tanaka |
Organization
Department of Orthopedic Surgery, Tohoku University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi Prefecture
TEL
022-717-7245
hidetatsu.tanaka.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hidetatsu |
| Middle name | |
| Last name | Tanaka |
Organization
Department of Orthopedic Surgery, Tohoku University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi Prefecture
TEL
022-717-7245
Homepage URL
hidetatsu.tanaka.c7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopedic Surgery, Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Osteotomy surgery was performed using the guide on July 8, 2024, July 22, 2024, October 7, 2024, February 17, 2025, April 14, 2025, July 17, 2025, October 27, 2025, and November 10, 2025.
The patient's progress is good.
Results date posted
| 2024 | Year | 11 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Eight cases
Management information
Registered date
| 2024 | Year | 05 | Month | 15 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062143
