UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028159 |
|---|---|
| Receipt number | 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 | 2021/01/12 14:39:37 |
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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
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
naomik58@aol.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | 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
| 2017 | Year | 07 | Month | 10 | Day |
Last modified on
| 2021 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026685
