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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028512
Receipt No. 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 2019/08/07

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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
Email 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
Email goromoto@ortho.med.kyushu-u.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
Email 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 Open public recruiting
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
2019 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032629

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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