UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053502 |
|---|---|
| Receipt number | R000061065 |
| Scientific Title | Evaluation of Tensor Fascia Latae and Iliotibial Band Stiffness After Total Hip Arthroplasty and Its Relationship with Pain and Range of Motion |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2024/01/31 22:39:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of Tensor Fascia Latae and Iliotibial Band Stiffness After Total Hip Arthroplasty and Its Relationship with Pain and Range of Motion
Acronym
Evaluation of Tensor Fascia Latae and Iliotibial Band Stiffness After Total Hip Arthroplasty and Its Relationship with Pain and Range of Motion
Scientific Title
Evaluation of Tensor Fascia Latae and Iliotibial Band Stiffness After Total Hip Arthroplasty and Its Relationship with Pain and Range of Motion
Scientific Title:Acronym
Evaluation of Tensor Fascia Latae and Iliotibial Band Stiffness After Total Hip Arthroplasty and Its Relationship with Pain and Range of Motion
Region
| Japan |
Condition
Condition
Total Hip Arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate changes over time in stiffness of the TFL and ITB after THA using SWE, and compare them to early postoperative pain and ROM of the hip joint. Additionally, we examined the relationship between changes in leg length and femoral offset (FO), which may affect TFL and ITB stiffness.
Basic objectives2
Others
Basic objectives -Others
This study aimed to evaluate changes over time in stiffness of the TFL and ITB after THA using SWE, and compare them to early postoperative pain and ROM of the hip joint. Additionally, we examined the relationship between changes in leg length and femoral offset (FO), which may affect TFL and ITB stiffness.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
we examined the correlation between changes in leg length and femoral offset (FO), pain during gait, hip adduction, extension ROM, and SWE values of each muscle.
Key secondary outcomes
we examined the correlation between changes in leg length and femoral offset (FO), pain during gait, hip adduction, extension ROM, and SWE values of each muscle.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 81 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Forty-eight patients with 64 hips who underwent initial THA by direct anterior approach between April 2023 and November 2023
Key exclusion criteria
Exclusion criteria were previous hip surgery, rheumatoid arthritis, previous neurological involvement, HbA1c >7.5%, and poor general condition requiring medical consultation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | haruki |
| Middle name | |
| Last name | osanami |
Organization
Keiyu Orthopaedic Hospital
Division name
Department of Rehabilitation
Zip code
374-0013
Address
2267 Akoda, Tatebayashi, Gunma 374-0013, Japan
TEL
0276499000
haruki.osanami140317@gmail.com
Public contact
Name of contact person
| 1st name | haruki |
| Middle name | |
| Last name | osanami |
Organization
Keiyu Orthopaedic Hospital
Division name
Department of Rehabilitation
Zip code
374-0013
Address
2267 Akoda, Tatebayashi, Gunma 374-0013, Japan
TEL
0276499000
Homepage URL
haruki.osanami140317@gmail.com
Sponsor or person
Institute
Department of Rehabilitation
Institute
Department
Personal name
osanami haruki
Funding Source
Organization
Department of Rehabilitation Keiyu Orthopaedic Hospital
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
Department of Rehabilitation Keiyu Orthopaedic Hospital
Address
2267 Akoda, Tatebayashi, Gunma 374-0013, Japan
Tel
0276499000
haruki.osanami140317@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
群馬県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 31 | 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
48
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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was fully explained to the participants in writing and verbally, and written informed consent was obtained from all the participants.
Management information
Registered date
| 2024 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061065
