UMIN-CTR Clinical Trial

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