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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017497
Receipt No. 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

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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
Email 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
Email izumi.kokubun@tokushukai.jp

Sponsor
Institute Shonan Kamakura Jiont Reconstruction Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020280

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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