UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030749 |
|---|---|
| Receipt number | R000035118 |
| Scientific Title | Evaluation of Functional Recovery After Total Hip Arthroplasty Performed Through AMIS versus Direct Lateral Approach |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2020/01/23 15:33:38 |
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Basic information
Public title
Evaluation of Functional Recovery After Total Hip Arthroplasty Performed Through AMIS versus Direct Lateral Approach
Acronym
Evaluation of Functional Recovery After Total Hip Arthroplasty Performed Through AMIS versus Direct Lateral Approach
Scientific Title
Evaluation of Functional Recovery After Total Hip Arthroplasty Performed Through AMIS versus Direct Lateral Approach
Scientific Title:Acronym
Evaluation of Functional Recovery After Total Hip Arthroplasty Performed Through AMIS versus Direct Lateral Approach
Region
| Japan |
Condition
Condition
Total Hip Arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Functional Recovery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HOOS modified score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
AMIS vs Direct Lateral Approach
Interventions/Control_2
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
| 55 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Male and female aged 55-75 years at time of surgery
2.Patients who are candidate for primary total hip arthroplasty.
3.Patients are categorized Type I or II on Crowe classification, or ION.
4.Patients have informed consent.
5. Patients deemed capable of understanding the aims of the study and expressing willingness to comply with the post-operative review program
Key exclusion criteria
1.Patients whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
2.Those already treated by with a THR (i.e. requiring a revision hip replacement).
3.Patients suffering from back diseases or ipsilateral knee pathologies
4.Patients treated by with a contralateral hip replacement or presenting contralateral hip diseases.
5.Patients requiring a bilateral total hip replacement
6.Patients whose BMI exceeds 40
7.Any case not described in the inclusion criteria
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Etsuo |
| Middle name | |
| Last name | Chosa |
Organization
University of Miyazaki Hospital
Division name
Department of Orthopaedic Surgery
Zip code
889-1692
Address
5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL
0985-85-0986
seikei@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Etsuo |
| Middle name | |
| Last name | Chosa |
Organization
University of Miyazaki Hospital
Division name
Department of Orthopaedic Surgery
Zip code
889-1692
Address
5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL
0985-85-0986
Homepage URL
seikei@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Medacta Japan Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Support Center
Address
5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
Tel
0985-85-9403
igakubu_kenkyu@med.miyazaki-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 10 | Day |
Last modified on
| 2020 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035118
