UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047966 |
|---|---|
| Receipt number | R000054681 |
| Scientific Title | Patient satisfaction and joint motion function with and without hip capsular ligament repair in total hip arthroplasty |
| Date of disclosure of the study information | 2022/09/15 |
| Last modified on | 2025/06/09 16:18:51 |
* 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
Patient satisfaction and joint motion function with and without hip capsular ligament repair in total hip arthroplasty
Acronym
Patient satisfaction and joint motion function with and without hip capsular ligament repair in total hip arthroplasty
Scientific Title
Patient satisfaction and joint motion function with and without hip capsular ligament repair in total hip arthroplasty
Scientific Title:Acronym
Patient satisfaction and joint motion function with and without hip capsular ligament repair in total hip arthroplasty
Region
| Japan |
Condition
Condition
osteoarthritis of hip joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the usefulness of repairing the intraoperatively separated iliopsoas femoral ligament in total hip arthroplasty (THA) with a control group of resection without repair.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of postoperative days until automatic lower limb extension and raising (SLR) is possible
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Complete repair of the iliofemoral ligament
Interventions/Control_2
Resection of the glenohumeral ligament
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
Osteoarthritis of the hip joint scheduled for total hip arthroplasty
Key exclusion criteria
Previous hip joint surgery
Bilateral simultaneous THA
Cases other than osteoarthritis
Patients with complications of dialysis, heart failure, tetraplegia
Patients whom the investigator considers inappropriate for inclusion
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Yukizawa |
Organization
Yokohama City University Medical Center
Division name
Department of Orthopaedic Surgey
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa
TEL
0452615656
yukihey@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Yukizawa |
Organization
Yokohama City University Medical Center
Division name
Department of Orthopaedic Surgey
Zip code
2360057
Address
4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa
TEL
0452615656
Homepage URL
yukihey@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
Yokohama City University Medical Center
Address
4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa
Tel
0452615656
yukihey@yokohama-cu.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
| 2022 | Year | 09 | Month | 15 | 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
| 2022 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054681
