UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050500 |
|---|---|
| Receipt number | R000057522 |
| Scientific Title | Leg length correction based on perceived leg length discrepancy in total hip arthroplasty |
| Date of disclosure of the study information | 2023/03/06 |
| Last modified on | 2023/03/06 11:54:30 |
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Basic information
Public title
Leg length correction based on perceived leg length discrepancy in total hip arthroplasty
Acronym
Leg length correction based on perceived leg length discrepancy in total hip arthroplasty
Scientific Title
Leg length correction based on perceived leg length discrepancy in total hip arthroplasty
Scientific Title:Acronym
Leg length correction based on perceived leg length discrepancy in total hip arthroplasty
Region
| Japan |
Condition
Condition
Hip osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When performing total hip arthroplasty with retraction, adjustments are usually made to equalize the leg lengths on the images. However, there are scattered cases in which patients feel uncomfortable about the leg length difference even though it looks fine on the images due to pelvic tilt or different original leg lengths. In this study, we focus on subjective leg length difference, planning before surgery, and evaluating it with a patient-oriented evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Perceived leg length difference and hip function study
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
A 4 mm thick plate is placed in the patient's measurements preoperatively to investigate the amount of suitable correction, which is then used to develop a preoperative plan.
Interventions/Control_2
A 4 mm thick plate is placed in the patient's measurements preoperatively to investigate the amount of suitable correction, which is then used to develop a preoperative plan.
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases of unilateral HOA and bilateral HOA with total hip arthroplasty was already performed on the opposite side.
Key exclusion criteria
Crowe 3 or more dislocation cases, cases with any surgery on the target side
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Imai |
Organization
Niigata University
Division name
Div. of Comprehensive Musculoskeletal Medicine,
Zip code
9518510
Address
1-757, Asahimachi-dori, Niigata City, Niigata Prefecture, Japan
TEL
0252272272
imainorio2001@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Imai |
Organization
Niigata University
Division name
Div. of Comprehensive Musculoskeletal Medicine
Zip code
9518510
Address
1-757, Asahimachi-dori, Niigata City, Niigata Prefecture, Japan
TEL
0252272272
Homepage URL
imainorio2001@yahoo.co.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata 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
Niigata University
Address
1-757, Asahimachi-dori, Niigata City, Niigata Prefecture, Japan
Tel
0252272272
imainorio2001@yahoo.co.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
| 2023 | Year | 03 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2023 | Year | 03 | Month | 06 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057522
