UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017497 |
|---|---|
| Receipt number | R000020280 |
| Scientific Title | Accolade TMZF Femoral Stem with Trident Ceramic on Ceramic and Crossfire Polyethylene Prospective Randomized Comparison Study |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2018/01/10 16:20:32 |
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Basic information
Public title
Accolade TMZF Femoral Stem with Trident Ceramic on Ceramic and Crossfire Polyethylene Prospective Randomized Comparison Study
Acronym
Prospective Randomized Comparison Study of Accolade TMZF with 2 Different Bearing Choices.
Scientific Title
Accolade TMZF Femoral Stem with Trident Ceramic on Ceramic and Crossfire Polyethylene Prospective Randomized Comparison Study
Scientific Title:Acronym
Prospective Randomized Comparison Study of Accolade TMZF with 2 Different Bearing Choices.
Region
| Japan |
Condition
Condition
HIP Osteoarthritis,Avascular,Nocrosis,and THA for Femoral Neck Fracture Cases
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety ond efficacy of the prosthesis by collecting and comparing the clinical data of 2 different bearing choices,Ceramic-on-Ceramic and Cerami-on-Highly Crosslinked Polyethylene,with Accolade TMZF Stem by prospective randomized Comparison basis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Fixation of Prosthesis (Engh Classification), Position of Prosthesis (Alignment and depth), Radiolucent Line (Gruen Zone for Femur and Delee Charnley Zone for Acetabulum), and Osteolysis(Both Femur and Acetabulum)
Key secondary outcomes
JOA Score,Thigh Pain, Trendelenburg's Sign,Squeaking,and Other Complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Accolade TMZF Stem
Interventions/Control_2
Trident HA shell
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
| 66 | years-old | > |
Gender
Female
Key inclusion criteria
1) Patients have diagnosis of osteoarthritis,avascular necrosis, or femoral neck fracture,and are candidates for primary THA
2) Patients have diagnosis of other symptoms and are candidates for THA
Key exclusion criteria
1) Patients need cement fixation of prosthesis
2) Patients are candidates for Revision THA
3) Patients have diagnosis of Rheumatoid Arthritis
4) Patients have infectious disease or have risk of infection
5) Patients who have a neuromuscular or neurosensory dificiency, which limits ability to evaluate the safety and efficacy of the device
6) Patients who are judged ineligible by primary doctor cannot conduct standard rehabilitation
7) Patients are 66 years old or over
8) Male patients
9) Patients who are judged ineligible with reasonable reason by primary doctor
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Hirakawa |
Organization
Shonan Kamakura Joint Reconstruction Center
Division name
Department of Orthopaedic Surgery
Zip code
Address
5-4-17 Dai, Kamakura, Kanagawa
TEL
0466-47-2377
mail@skjrc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Riichiro Tsukamoto |
Organization
Shonan Kamakura Jiont Reconstruction Center
Division name
Department of Orthopaedic Surgery
Zip code
Address
5-4-17 Dai, Kamakura, Kanagawa
TEL
0467-47-2377
Homepage URL
izumi.kokubun@tokushukai.jp
Sponsor or person
Institute
Shonan Kamakura Jiont Reconstruction Center
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura Jiont Reconstruction Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人沖縄徳洲会 湘南鎌倉人工関節センター
（Shonan Kamakura Jiont Reconstruction Center）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 11 | 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
| 2009 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 12 | Month | 06 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 11 | Day |
Last modified on
| 2018 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020280
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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