UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008991 |
|---|---|
| Receipt number | R000010543 |
| Scientific Title | Evaluation of bone remodeling in THA with Trabecular Metal Primary Hip Prosthesis |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2015/01/07 09:51:40 |
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Basic information
Public title
Evaluation of bone remodeling in THA with Trabecular Metal Primary Hip Prosthesis
Acronym
Outcome study of Trabecular Metal Primary Hip Prosthesis
Scientific Title
Evaluation of bone remodeling in THA with Trabecular Metal Primary Hip Prosthesis
Scientific Title:Acronym
Outcome study of Trabecular Metal Primary Hip Prosthesis
Region
| Japan |
Condition
Condition
secondary coxarthrosis with developmental dysplasia of the hip (DDH)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate bone remodeling in total hip arthroplasty (THA) with Trabecular Metal Primary Hip Prosthesis as below;
Primary objective:
To compare changes of bone mineral density (BMD) around Trabecular Metal™ Primary Hip Prosthesis to that around VerSys® HA-TCP FMT Stem for proving superiority of Trabecular Metal™ Primary Hip Prosthesis
Secondary objective:
To explore bone remodeling around shell covered with Trabecular Metal™
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Bone mineral density (BMD) assessments:
BMD around stem with Gruen classification and around cup with 4 ROIs will be measured within 1 week after operation, at the time of discharge, 12, 24, 52 and 104 weeks postoperatively. The change of BMD from immediately post-operation will be calculated at each visit.
Key secondary outcomes
Clinical Assessment:
JOA Score will be evaluated at the time of pre-operation, discharge, 12, 24, 52 and 104 weeks postoperatively.
Radiographic Assessment:
X-ray will be taken before operation, within 1 week after operation, at the time of discharge, 12, 24, 52 and 104 weeks postoperatively. Evaluation of stress shielding, spot welds or others will be performed around stem with Gruen classification and around cup with DeLee & Charenly classification. If there is a gap between shell covered with Trabecular Metal™ and acetabulum, the time will be investigated until the gap is completely filled with bone.
Questionnaire:
Health status will be investigated with EQ-5D at the time of pre-operation, discharge, 12, 24, 52 and 104 weeks postoperatively.
Safety Evaluation:
When an adverse event or a product failure for which a causal relationship to the investigational or comparative device cannot be ruled out occurs, principal investigator or sub-investigator should report the event or the failure in accordance with the procedure outlined in section 14 of the protocol.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
THA with Trabecular Metal™ Primary Hip Prosthesis
Interventions/Control_2
THA with VerSys HA-TCP Fiber Metal Taper 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 THA
2) Age (at the day of obtainment of the consent): 20 to 75 years old
3) Sex:Both males and females
4) Patient who is able to provide the consent and to sign the consent form
5) Patient who is willing and able to complete the scheduled follow-up evaluations described in the protocol
Key exclusion criteria
1) Patient who is skeletally immature
2) Patient with loss of abductor musculature in the affected limb
3) Patient with poor bone stock (e.g., steroid-induced metabolic bone disease)
4) Patient with poor skin coverage around the hip joint
5) Patient with neuromuscular disease (e.g., Charcot's joint) in the affected limb
6) Patient with infection symptoms (e.g., osteomyelitis in proximal femur, pyrogenetic infection of the hip)
7) Patient with stove pipe Dorr type C femur
8) Patient with osteoradionecrosis of the acetabulum
9) Patient with systematic or local infection
10) Patient with vascular deficiency in the affected limb that may lead to inadequate skeletal fixation
11) Patient who is not able to independently walk before THA
12) Patient who is suspected to have metal allergy
13) Patient who is pregnant, suspected pregnancy or planned to get pregnant during the study period
14) Patient with any comorbidity (e.g. dementia, schizophrenia, depression, panic disorder, generalized anxiety disorder, etc.) which may affect the ability of informed consent or completion of assessments
15) Patient who have planned to undergo THA, TKA, osteotomy or any operation of lower extremities within 6 months after enrollment
16) Patient who underwent THA, TKA, osteotomy or any operation of lower extremities less than 6 months before enrollment
17) Patient having other medical condition who is considered to be inappropriate by the investigator to participate in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Uchiyama |
Organization
Zimmer K.K.
Division name
Clinical Affairs
Zip code
Address
1-17, Toranomon 4-chome, Minato-ku, Tokyo 105-0001, Japan
TEL
03-6402-6610
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chie Nishizawa |
Organization
Zimmer K.K.
Division name
Clinical Affairs
Zip code
Address
1-17, Toranomon 4-chome, Minato-ku, Tokyo 105-0001, Japan
TEL
03-6402-6764
Homepage URL
Sponsor or person
Institute
Zimmer K.K.
Institute
Department
Personal name
Funding Source
Organization
Zimmer K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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）、愛媛大学医学部附属病院（愛媛）、三重大学病院（三重県）、藤田保健衛生大学病院（愛知県）、昭和大学藤が丘病院（神奈川県）、横浜市立大学附属市民総合医療センター（神奈川県）/
Kyushu University Hospital (Fukuoka), Ehime University Hospital (Ehime), Mie University Hospital (Mie), Fujita Health University Hospital (Aichi), Showa University Fujigaoka Hospital (kanagawa), okohama City University Medical Center (kanagawa)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2016 | 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
| 2012 | Year | 09 | Month | 27 | Day |
Last modified on
| 2015 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010543
