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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028159
Receipt No. R000026685
Scientific Title Utitilty and safety of computer assisted surgery for hip arthroscopy
Date of disclosure of the study information 2017/07/11
Last modified on 2019/07/12

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Basic information
Public title Utitilty and safety of computer assisted surgery for hip arthroscopy
Acronym Utitilty and safety of computer assisted surgery for hip arthroscopy
Scientific Title Utitilty and safety of computer assisted surgery for hip arthroscopy
Scientific Title:Acronym Utitilty and safety of computer assisted surgery for hip arthroscopy
Region
Japan

Condition
Condition Hip labrum tear, femoroacetbular impingement
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To comfirm the utility and safety of computer assisted hip arthroscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evauation of clinical assesment, radiographic findings, comlication after computer assited hip arthroscopy at 3, 6, and 12 month postoperatively.
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 Historical
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Computer assisted techniques for hip arthroscopic surgery(preoperative planning, intraoperative assistance by computer navigation system)
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
15 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1. age at enrollement 15-70
2. Femoroacetabular impingement, early stage osteoarthritis of the hip
3. No history of hip surgery
4. Patient with informed concent about this clinical trial
Key exclusion criteria 1. Osteonecrosis of the hip, bone tumor around hip joint, rheumatoid arthritis
2. Other disqualification factors judged by medical dosctor
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Naomi
Middle name
Last name Kobayashi
Organization Yokohama City University Medical Center
Division name Orthopaedics
Zip code 2320024
Address Kanagawa, Yokohama city, Minami-ku, Urafune-cho 4-57
TEL 045-261-5656
Email naomik58@aol.com

Public contact
Name of contact person
1st name Naomi
Middle name
Last name Kobayashi
Organization Yokohama City University
Division name Orthopaedics
Zip code 2360004
Address Kanagawa, Yokohama city, Kanazawa-ku, Fukuura 3-9
TEL 045-787-2800
Homepage URL
Email naomik58@aol.com

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization None
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 Clinical Research Coordination Department, Center for Novel and Exploratory Clinical Trials
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
Tel +81-45-787-2714
Email nextjim1@yokohama-cu.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
2017 Year 07 Month 11 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
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 10 Day
Last modified on
2019 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026685

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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