UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056132 |
|---|---|
| Receipt number | R000064137 |
| Scientific Title | A Prospective Interventional Study on the Expansion of Activity Levels in Patients Undergoing Unilateral Primary Total Hip Arthroplasty with an Anterior Approach |
| Date of disclosure of the study information | 2024/12/24 |
| Last modified on | 2025/11/13 13:40:08 |
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Basic information
Public title
A Prospective Interventional Study on the Expansion of Activity Levels in Patients Undergoing Unilateral Primary Total Hip Arthroplasty with an Anterior Approach
Acronym
A Prospective Interventional Study on the Expansion of Activity Levels in Patients Undergoing Unilateral Primary Total Hip Arthroplasty with an Anterior Approach
Scientific Title
A Prospective Interventional Study on the Expansion of Activity Levels in Patients Undergoing Unilateral Primary Total Hip Arthroplasty with an Anterior Approach
Scientific Title:Acronym
A Prospective Interventional Study on the Expansion of Activity Levels in Patients Undergoing Unilateral Primary Total Hip Arthroplasty with an Anterior Approach
Region
| Japan |
Condition
Condition
Unilateral Osteoarthritis of the Hip and Idiopathic Osteonecrosis of the Femoral Head
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether postoperative walking ability can be safely assessed based on walking speed in the Timed Up and Go test in patients who underwent unilateral total hip arthroplasty.
Basic objectives2
Others
Basic objectives -Others
To examine whether evaluating walking ability based on walking speed in the Timed Up and Go test can reduce the length of hospital stay.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in walking speed two to three weeks following total hip arthroplasty
Key secondary outcomes
Reduction in the length of hospital stay two to three weeks after total hip arthroplasty
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Perform the Timed Up and Go test daily from the day before to 2-3 weeks after total hip arthroplasty, measuring walking time to assess walking speed
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with unilateral osteoarthritis of the hip or idiopathic osteonecrosis of the femoral head undergoing primary unilateral total hip arthroplasty
Key exclusion criteria
Patients with evident consciousness disorders, severe psychiatric symptoms, or difficulty understanding Japanese
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Baba |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
980-8574
Address
1-1 Seiryoutyou, Aoba-ku, SendaiCity, Miyagi, Japan
TEL
022-717-7245
kazuyoshi.baba.e3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Baba |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
980-8574
Address
1-1 Seiryoutyou, Aoba-ku, SendaiCity, Miyagi, Japan
TEL
022-717-7245
Homepage URL
kazuyoshi.baba.e3@tohoku.ac.jp
Sponsor or person
Institute
Department of Orthopedic Surgery, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopedic Surgery, Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 12 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064137
