UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063467 |
|---|---|
| Receipt number | R000072639 |
| Scientific Title | Prospective Observational Study of Safety & Clinical Performance Following Primary Total Hip Arthroplasty with iTechnology Implant System |
| Date of disclosure of the study information | 2026/10/29 |
| Last modified on | 2026/10/29 18:14:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective Observational Study of Safety & Clinical Performance Following Primary Total Hip Arthroplasty with iTechnology Implant System
Acronym
Hip iTechnology Study
Scientific Title
Prospective Observational Study of Safety & Clinical Performance Following Primary Total Hip Arthroplasty with iTechnology Implant System
Scientific Title:Acronym
Hip iTechnology Study
Region
| Japan |
Condition
Condition
Hip Joint Diseases
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect and evaluate data on the safety and clinical effectiveness of the iTechnology Implant System in a diverse patient population treated in routine clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Incidence of periprosthetic joint infection (PJI) within 90 days postoperatively.
*Study device and/or procedure-related adverse events rate.
*Implant Survival rate.
*Rate of infection resolution with and without surgical intervention.
*Radiographic findings (such as spot welds, loosening, osteolysis, bone resorption, and bony growth and other signs of implant failure).
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
*Patients who are considered as appropriate candidates to receive Primary THA by the surgeon via risk-benefit balance assessment.
*Patients who are at least 18 years old at the time of Informed Consent.
*Skeletally mature patients.
*Patients who are willing to complete the follow-up visits scheduled as part of routine clinical care.
*Patients who can provide written consent using the IRB/EC approved ICF.
Key exclusion criteria
*Patients scheduled to undergo simultaneous bilateral THA.
*Patients scheduled for THA due to neoplastic disease.
*Patients scheduled to undergo simultaneous surgery on other joints or anatomical sites.
*Patients who have underwent a musculoskeletal surgical procedure within 90 days prior to the index procedure.
*Patients in whom implants other than the study device (e.g., cables) were concomitantly used during surgery.
*Patients in whom the study device was converted to other implants during surgery.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tsuchiya |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Department of Orthopaedic Surgery
Zip code
247-8581
Address
132 Katsuracho, Sakae-ku, Yokohama, Kanagawa 247-8581, Japan
TEL
0570-012-171
yukako.shiraishi@zimmerbiomet.com
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Shiraishi |
Organization
Zimmer Biomet G.K.
Division name
Clinical Operations
Zip code
108-0073
Address
5-19 Mita 3-chome, Minato-ku, Tokyo 108-0073, Japan
TEL
03-4331-8600
Homepage URL
yukako.shiraishi@zimmerbiomet.com
Sponsor or person
Institute
Zimmer Biomet G.K.
Institute
Department
Personal name
Funding Source
Organization
Zimmer Biomet G.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
HURECS Review Board of Human Rights and Ethics for Clinical Studie
Address
24th Floor, Kyobashi Edogrand, 2-2-1 Kyobashi, Chuo-ku, Tokyo 104-0031, Japa
Tel
03-5213-0028
yukako.shiraishi@zimmerbiomet.com
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
| 2026 | Year | 10 | Month | 29 | 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
Results date posted
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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Where appropriate, subgroup analyses will be conducted for each outcome measure, stratified by sex, age group, preoperative diagnosis, PJI risk, and other relevant factors.
Management information
Registered date
| 2026 | Year | 10 | Month | 29 | Day |
Last modified on
| 2026 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072639
