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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047608
Receipt No. R000054287
Scientific Title Randomized controlled study comparing Augmented Reality (AR) Hip Navigation System versus conventional instrumentation
Date of disclosure of the study information 2022/05/01
Last modified on 2022/04/27

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Basic information
Public title Randomized controlled study comparing Augmented Reality (AR) Hip Navigation System versus conventional instrumentation on THA in Lateral Decubitus position
Acronym AR Hip RCT on THA in lateral decubitus position
Scientific Title Randomized controlled study comparing Augmented Reality (AR) Hip Navigation System versus conventional instrumentation
Scientific Title:Acronym AR Hip RCT on THA in lateral decubitus position
Region
Japan

Condition
Condition Hip Arthroplasty
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the accuracy of AR Hip by comparing the difference between the target placement angle and the postoperative placement angle between the AR Hip group and the conventional group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The difference between the target placement angle and the postoperative placement angle between the AR Hip group and the conventional group.
Key secondary outcomes The influence of surgery time / Incidence of adverse event after THA / Harris Hip Score and JHEQ degree of improvement / Acetabular Cup alignment accuracy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 G7 acetabular system THA with AR Hip System as the Control group
Interventions/Control_2 G7 acetabular system THA without AR Hip System as the Control group
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria - 20 to 80 years of age, inclusive
- Skeletally mature
- Have undergo treatment or in need of primary THA treatment of non-union, femoral neck fracture, unmanageable by other techniques
- Type 1 or Type2 of Crowe classification
- Willing and able to complete scheduled follow-up evaluations as described in the study protocol
- Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent
Key exclusion criteria - Has an anteversion of 20 degrees or more at the target placement angle
- Has an excessive flexion contracture
- Has an asymmetric pelvis
- Has a history of hip surgery on the affected side
- Judged as inappropriate subject by surgeons performing regenerative medicine
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroyuki / Naoyuki
Middle name
Last name Ogawa / Hirasawa
Organization Hokusuikai Kinen Hospital
Division name Orthopedic
Zip code 310-0035
Address 3-2-1 Higashihara, Mito-shi, Ibaraki 310-0035, Japan
TEL 029-303-3003
Email wscww899@yahoo.co.jp

Public contact
Name of contact person
1st name Yukako
Middle name
Last name Shiraishi
Organization Zimmer Biomet G.K.
Division name Clinical Affairs
Zip code 105-0011
Address 11-1 Shibakoen 2-chome, Minato-ku, Tokyo 105-0011, Japan
TEL 03-6402-6600
Homepage URL
Email yukako.shiraishi@zimmerbiomet.com

Sponsor
Institute Hokusuikai Kinen Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokusuikai Kinen Hospital IRB
Address 3-2-1 Higashihara, Mito-shi, Ibaraki 310-0035, Japan
Tel 029-303-3003
Email 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 土浦協同病院(茨城県)、聖マリアンナ医科大学病院(神奈川県)、市立甲府病院(山梨県)、同愛記念病院(東京都)、新渡戸記念中野総合病院(東京都)

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 01 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 Preinitiation
Date of protocol fixation
2022 Year 04 Month 13 Day
Date of IRB
2022 Year 04 Month 21 Day
Anticipated trial start date
2022 Year 06 Month 01 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 04 Month 27 Day
Last modified on
2022 Year 04 Month 27 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054287

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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