UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004220 |
|---|---|
| Receipt number | R000005072 |
| Scientific Title | Clinical research on Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology |
| Date of disclosure of the study information | 2010/09/16 |
| Last modified on | 2014/10/21 14:09:45 |
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Basic information
Public title
Clinical research on Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology
Acronym
Clinical research on Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology
Scientific Title
Clinical research on Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology
Scientific Title:Acronym
Clinical research on Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology
Region
| Japan |
Condition
Condition
Patients who have been diagnosed secondary hip osteoarthritis with acetabular dysplasia (Crowe classification; type I to IV)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the consistency of stem component/neck component of the M/L Taper Kinectiv Stem selected through preoperative 3D-templating and the device actually implanted and the clinical outcomes including X-ray evaluation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the consistency of stem component/neck component of the M/L Taper Kinectiv Stem selected through preoperative 3D-templating and the device actually implanted
Key secondary outcomes
To investigate clinical outcomes(JOA score, Harris Hip Score, SF-12 and X-ray) for 24-month postoperatively
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology by THA
Interventions/Control_2
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)Age: 20 to 75 years
2)Sex: Both males and females
3)A patient with ability to consent who can sign the informed consent form by themselves
4)A patient who are expected to cooperate with this study throughout the study period
Key exclusion criteria
1)A patient who underwent artificial joint replacement or osteotomy of the affected lower limb
2)A patient with infection-like symptoms such as osteomyelitis of the proximal femur and suppurative infection of the hip joint.
3)A patient with neuromuscular disorder (Charcot's joint, etc.) in the affected limb
4)A patient who are skeletally immature
5)A patient with loss or atrophy of the abductor muscle in the affected limb
6)A patient with insufficient bone mass (due to steroid-induced metabolic bone disorder, etc.)
7)A patient with insufficient skin coverage around the hip joint
8)A patient with local or systemic infection
9)A patient with the stove-pipe femur
10)A patients with suspected metal allergies
11)Other patients who are determined to be ineligible for total hip arthroplasty and this study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Hirakawa |
Organization
Shonan Kamakura Joint Reconstruction Center
Division name
Department of Orthopaedic Surgery
Zip code
Address
4-17, 5-chome, Dai, Kamakura-shi, Kanagawa prefecture, Japan
TEL
0467-47-2377
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Tsuji |
Organization
Shonan Kamakura Joint Reconstruction Center
Division name
Department of Orthopaedic Surgery
Zip code
Address
4-17, 5-chome, Dai, Kamakura-shi, Kanagawa prefecture, Japan
TEL
0467-47-2377
Homepage URL
koji502@mac.com
Sponsor or person
Institute
Shonan Kamakura Joint Reconstruction Center
Institute
Department
Personal name
Funding Source
Organization
Zimmer Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
U.S.
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
医療法人 沖縄徳洲会 湘南鎌倉人工関節センター(神奈川県）/ Shonan Kamakura Joint Reconstruction Center(kanagawa)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 16 | 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
| 2010 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 16 | Day |
Last modified on
| 2014 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005072
