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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004220
Receipt No. 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

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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
Email

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
Email koji502@mac.com

Sponsor
Institute Shonan Kamakura Joint Reconstruction Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005072

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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