UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028512 |
|---|---|
| Receipt number | R000032629 |
| Scientific Title | Evaluation of bone remodeling after total hip arthroplasty using Initia Stem |
| Date of disclosure of the study information | 2017/08/03 |
| Last modified on | 2023/08/24 14:11:40 |
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Basic information
Public title
Evaluation of bone remodeling after total hip arthroplasty using Initia Stem
Acronym
Bone remodeling after THA using Initia Stem
Scientific Title
Evaluation of bone remodeling after total hip arthroplasty using Initia Stem
Scientific Title:Acronym
Bone remodeling after THA using Initia Stem
Region
| Japan |
Condition
Condition
Secondary osteoarthritis caused by hip dysplasia or osteonecrosis of the femoral head
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the change of bone mineral density around Initia Stem after total hip arthroplasty in comparison with that around Perfix HA 910 stem based on Randomized Controlled Trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the change of bone mineral density around the stem between Initia stem and Perfix HA 910 stem based on previous report describing the change of bone mineral density around cement-less stem.
Key secondary outcomes
To examine the relationship of the change of bone mineral density around the cement-less stem with investigation items, including background, clinical assessment, radiograph, and patient-reported outcome.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Total hip arthroplasty using Initia Stem
Interventions/Control_2
Total hip arthroplasty using Perfix HA 910 stem
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Primary total hip arthroplasty
2) Age: 20-75 years old
3) Male and Female
4) Patients with the ability of consent and writing
5) Patients who can visit hospital as scheduled during the research period
Key exclusion criteria
1) Patients with immature bone structure
2) Patients with the loss of abduction muscle in affected leg
3) Patients with insufficient bone mineral density (e.g. Corticosteroid-induced metabolic bone disease)
4) Patients with insufficient skin covering around the hip joint
5) Patients with neuromuscular disease (e.g. Charcot disease) in affected leg
6) Patients with the infection (e.g. osteomyelitis in proximal femur or purulent infection in the hip joint)
7) Patients with stovepipe-like femur
8) Patients with radiation osteonecrosis of acetabulum
9) Patients with systemic or local infection
10) Patients with vascular interruption in affected leg
11) Patients without the ability of walking at the postoperative time
12) Suspicious patients with metal allergy
13) Pregnant patients, pregnant suspicious patients, or patients who hope for pregnancy
14) Patients with the disease which can affect consent or evaluation of the study, including dementia, schizophrenia, depression, panic disorder, or generalized anxiety disorder
15) Patients who need to undergo the lower extremity surgery within six months after participating in the study, including total hip arthroplasty and total knee arthroplasty
16) Patients who underwent the lower extremity surgery within six months before participating in the study, including total hip arthroplasty, total knee arthroplasty, or osteotomy
17) Patients who doctors judged unsuitable for the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Nakashima |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Orthopaedic Surgery
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5488
yasunaka@ortho.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Goro |
| Middle name | |
| Last name | Motomura |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Orthopaedic Surgery
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5488
Homepage URL
goromoto@ortho.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Nothing in particular
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
Research Support Division, Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 03 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2017 | Year | 08 | Month | 03 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032629
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| Registered date | File name |
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