UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008730 |
|---|---|
| Receipt number | R000010239 |
| Scientific Title | Multicenter clinical study to assess the effectiveness and safety of Aquala liner in total hip arthroplasty (THA) |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2019/08/28 15:34:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
takatori-orth@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010239
