UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022078 |
|---|---|
| Receipt number | R000025456 |
| Scientific Title | Clinical and radiographic analysis of the initial fixation mode of the tapered wedge stem "Accolade 2" |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2020/05/01 12:14:47 |
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Basic information
Public title
Clinical and radiographic analysis of the initial fixation mode of the tapered wedge stem "Accolade 2"
Acronym
Accolade 2 study
Scientific Title
Clinical and radiographic analysis of the initial fixation mode of the tapered wedge stem "Accolade 2"
Scientific Title:Acronym
Accolade 2 study
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip
Osteonecrosis of the hip
Classification by specialty
| Orthopedics | Operative medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the initial fixation mode of the Accolade 2 stem, and test clinical validity about the design concept of the stem
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Radiographic evaluation (CT, X-ray) and clinical evaluation (clinical score, patient-oriented QOL evaluation) until two years after surgery
Key secondary outcomes
adverse event
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients that primary total hip arthroplasty using Accolade 2 is planned by a normal medical service under health insurance.
The patients that a document agreement by the free will of the patients person himself was obtained after enough understanding after having received enough explanation on this study participation.
The patients with the intention to participate in this study during an observation period.
Key exclusion criteria
Patients with infection disease or the patients who are of high at risk.
Patients with a history of surgery such as the osteotomy on treated femur.
Extensive obese patients with BMI 40 or more.
Patients who have pregnant or pregnant possibilities.
Patients with systematic disease, neuromuscular disease, or sensory nerve disease, that the physician who has responsibility with this study think it may influence the evaluation.
Patients with immunosuppressive drug or continuous steroid use, that the physician who has responsibility with this study think it may influence the evaluation.
Patients who judged a study responsibility physician not to be eligible by other clear reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tamon |
| Middle name | |
| Last name | Kabata |
Organization
Kanazawa university hospital
Division name
Department of Orthopaedic surgery (Division of Rehabilitation)
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa, 920-8641, Japan
TEL
076-265-2374
tamonkabata@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tamon |
| Middle name | |
| Last name | Kabata |
Organization
Kanazawa university hospital
Division name
Department of Orthopaedic surgery (Division of Rehabilitation)
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa, 920-8641, Japan
TEL
076-265-2374
Homepage URL
http://icrek.w3.kanazawa-u.ac.jp/
seikei@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa university hospital, Department of Orthopaedic surgery (Division of Rehabilitation)
Institute
Department
Personal name
Funding Source
Organization
Stryker Japan K.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
Innovative clinical research center, Kanazawa university
Address
Takaramachi 13-1, Kanazawa, 920-8641, Japan
Tel
076-265-2090
hpsangak@adm.kanazawa-u.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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2016 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 27 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 30 | Day |
Other
Other related information
(1)X-ray
1)AP view
2)lateral view
(2) CT
Stem initial fixation mode
(3) Functional evaluation
JOA hip sore
(4) Patient satisfaction
EQ-5D (EuroQol 5 Dimension)
(5) Adverse event
1) adverse event associated with the study instrument
2) serious adverse event (every unfavorable medical event to occur in subjects including the prolongation of the length of hospital stay, reoperation, life threatened event, and death)
Management information
Registered date
| 2016 | Year | 04 | Month | 26 | Day |
Last modified on
| 2020 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025456
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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