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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022078
Receipt No. 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

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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
Email 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/
Email seikei@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa university hospital, Department of Orthopaedic surgery (Division of Rehabilitation)
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025456

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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