UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052451 |
|---|---|
| Receipt number | R000059865 |
| Scientific Title | A study of the clinical significance of hip joint capsule reconstruction in hip replacement surgery. |
| Date of disclosure of the study information | 2023/10/10 |
| Last modified on | 2023/10/10 10:32:03 |
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Basic information
Public title
A study of the clinical significance of hip joint capsule reconstruction in hip replacement surgery.
Acronym
A study of the clinical significance of hip joint capsule reconstruction in hip replacement surgery.
Scientific Title
A study of the clinical significance of hip joint capsule reconstruction in hip replacement surgery.
Scientific Title:Acronym
A study of the clinical significance of hip joint capsule reconstruction in hip replacement surgery.
Region
| Japan |
Condition
Condition
Osteoarthritis of the Hip, Idiopathic Osteonecrosis of the Hip, Femoral neck fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the clinical significance of hip joint capsule reconstruction in total hip replacement surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS score
Key secondary outcomes
ROM, Labo data, thigh girth, WOMAC, Forgotten Joint Score, JOA score, duration in hospital, muscle strength, complication
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
hip joint capsule reconstruction in total hip replacement surgery
Interventions/Control_2
hip joint capsule un-reconstruction in total hip replacement surgery
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Osteoarthritis of the hip, osteonecrosis of the hip, femoral neck fracture
Key exclusion criteria
40 kg or less, 120 kg or more, psychiatric disorders, drug dependence, allergies, renal failure, liver dysfunction, stroke, neurological disorders, angina pectoris, blocked both branches, history of hip surgery, infections, neuromuscular diseases
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Iwakiri |
Organization
Shiraniwa Hospital
Division name
Department of Orthopaedic Surgery
Zip code
630-0136
Address
6-10-1 Shiraniwadai Ikoma-city, Nara
TEL
0743-70-0022
kenpiecekenpiece@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Iwakiri |
Organization
Shiraniwa Hospital
Division name
Department of Orthopaedic Surgery
Zip code
630-0136
Address
6-10-1 Shiraniwadai Ikoma-city Nara
TEL
0743-70-0022
Homepage URL
kenpiecekenpiece@yahoo.co.jp
Sponsor or person
Institute
Shiraniwa Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Shiraniwa Hospital
Address
6-10-1 Shiraniwadai Ikoma-city Nara
Tel
0743-70-0022
kenpiecekenpiece@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 | 10 | Month | 10 | 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 | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 10 | Month | 10 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059865
