UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter clinical study to assess the effectiveness and safety of Aquala liner in total hip arthroplasty (THA)
Acronym	AQUALA study
Scientific Title	Multicenter clinical study to assess the effectiveness and safety of Aquala liner in total hip arthroplasty (THA)
Scientific Title:Acronym	AQUALA study
Region	Japan

Condition
Condition	Hip disorders including osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assessment of effectiveness and safety of the Aquala liner in patients who have the Aquala liner as an acetabular component of artificial hip joint
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Wear of the polyethylene liner
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Ceramic femoral head
Interventions/Control_2	Metal femoral head
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	Not applicable
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients who are indicated for a primary THA, and entered this study on the basis of their agreement to participate in the clinical trial. Patients who are indicated for this surgery on both sides can be included. 2) Patients who have an indication for the Aquala liner with a femoral head of 28 mm or 32 mm in diameter. 3) Patients aged 75 or younger at the time of a written prior consent to participate in this clinical study(no gender selective).
Key exclusion criteria	1) Patients who are not indicated for a primary THA 2) Patients with unstable clinical conditions 3) Patients whose weight is over the weight restriction of the femoral components to be used 4) Patients who are difficult to be followed for 5 years after the index surgery 5) Patients who are unable to evaluate their own QOL 6) Patients whose functions of the hip joints are difficult to evaluate due to disorders of other organs such as heart and nervous system 7) Patients who once had an artificial hip joint in the same hip joint 8) Patients who are at high risk of thrombosis or bleeding 9) Patients susceptive to infection 10)Patients receiving the anticancer drug therapy 11)Patients who are evaluated to be unsuitable for the subject of this study by the investigators
Target sample size	760

Research contact person
Name of lead principal investigator	1st name Sakae Middle name Last name Tanaka
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Orthopaedic Surgery, Sensory and Motor System Medicine, Surgical Sciences
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	tanakas-ort@h.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Yoshio Middle name Last name Takatori
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Div. Science for Joint Reconstruction
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	takatori-orth@umin.ac.jp

Sponsor
Institute	Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	KYOCERA Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The University of Tokyo, Clinical Research Review Board
Address	Tokyo 7-3-1, Hongo, Bunkyo-ku
Tel	03-5841-0818
Email	ehics@m.u-tokyo.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs032180333
Org. issuing International ID_1	Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 10 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	Terminated
Date of protocol fixation	2012 Year 07 Month 09 Day
Date of IRB	2012 Year 07 Month 26 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Reason for discontinuation:Regisetred to another database Registration database:Japan Registry of Clinical Trials, ID/jRCTs032180333

Management information
Registered date	2012 Year 08 Month 20 Day
Last modified on	2019 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010239