UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006107 |
|---|---|
| Receipt number | R000007146 |
| Scientific Title | Clinical study- Revelation® Hip System |
| Date of disclosure of the study information | 2011/08/08 |
| Last modified on | 2014/12/17 10:00:42 |
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Basic information
Public title
Clinical study- Revelation® Hip System
Acronym
Clinical study- Revelation® Hip System
Scientific Title
Clinical study- Revelation® Hip System
Scientific Title:Acronym
Clinical study- Revelation® Hip System
Region
| Japan | North America |
Condition
Condition
Coxarthrosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A prospective surgical approach comparison of the outcomes of 200
consecutive THA procedures: anterolateral approach vs. posterior approach.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of statistical differences between the outcomes as a result of the different surgical approaches and technique.
Key secondary outcomes
Radiographic assessment: Diagnostic imaging assessment by bone density measurement, and clinical functional assessment.
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
| Maneuver |
Interventions/Control_1
Surgical technique (Anterolateral approach)
Interventions/Control_2
Surgical technique(Posterior approach)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who consent to treatment and are willing to provide informed consent
2) Patients not undergoing total hip arthroplasty (THA)
3) Patients are expected to cooperate with this study during the study period and are available for a minimum of 2 years clinical follow-up post surgical date.
Key exclusion criteria
1) Patients undergoing joint replacement surgery or osteotomy at the affected limb.
2) Patients who have osteomyelitis at the proximal femur, hip suppurative infection and any other symptoms of infection.
3) Patients who have traumatic terminal osteoarthritis hip joint.
4) Patients who have a routine contraindication to surgery including but not limited to active infection, heart failure, lung failure or severe untreated bleeding abnormalities.
5) Pregnanancy
6) Mental impairment.
7) Patients under age 19
8) Metal allergy/ sensitivities
9) Others who the attending doctor decides not suitable for total hip arthroplasty and entry for this study.
Target sample size
100
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
0467-47-2377
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Tsuji |
Organization
Shonan Kamakura Joint Reconstruction Center
Division name
Department of Orthopaedic Surgery
Zip code
Address
5-4-17 Dai, Kamakura, Kanagawa
TEL
0467-47-2377
Homepage URL
koji502@mac.com
Sponsor or person
Institute
Shonan Kamakura Joint Reconstruction Center
Institute
Department
Personal name
Funding Source
Organization
NON
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
New York University Medical Center/Hospital for Joint Diseases
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（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 08 | 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
| 2011 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 03 | Day |
Last modified on
| 2014 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007146
