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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016779
Receipt No. R000019473
Scientific Title Prospective, Multi-centre Outcomes Study of Persona Knee System in TKA
Date of disclosure of the study information 2015/03/11
Last modified on 2019/10/08

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Basic information
Public title Prospective, Multi-centre Outcomes Study of Persona Knee System in TKA
Acronym APAC Persona Study
Scientific Title Prospective, Multi-centre Outcomes Study of Persona Knee System in TKA
Scientific Title:Acronym APAC Persona Study
Region
Japan Asia(except Japan) Australia

Condition
Condition Knee Arthroplasty
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine clinical performance and implant survivorship
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Implant survivorship/ Implant revision rate
Key secondary outcomes Patient Reported Outcomes, Clinical Assessments, Safety Assessment, and CT image Analysis

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Age 18 to 80 years old, inclusive.
2. Qualifies for a primary TKA based on physical exam and medical history,
including diagnosis of severe knee pain and disability due to at least one of
the following:
a) Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
b) Collagen disorders and/or avascular necrosis of the femoral condyle.
c) Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
d) Moderate valgus, varus, or flexion deformities.
e) The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
3. Participated in a study-related informed consent process.
4. Willing and able to provide written informed consent by signing and dating the IRB/EC approved informed consent form.
5. Willing and able to complete scheduled study procedures and follow-up evaluations.
6. Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee system implanted in accordance with product labelling.
Key exclusion criteria 1. Currently participating in any other surgical intervention studies or pain management studies
2. Previous history of infection in the affected joint and/or other local/ systemic infection that may affect the prosthetic joint
3. Insufficient bone stock on femoral or tibial surfaces
4. Skeletal immaturity
5. Neuropathic arthropathy
6. Any loss of musculature or neuromuscular disease that compromises the affected limb
7. Stable, painless arthrodesis in a satisfactory functional position
8. Severe instability secondary to the absence of collateral ligament integrity
9. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
10. Known or suspected sensitivity or allergy to one or more of the implant materials
11. Pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
12. Previously received partial or total knee arthroplasty for the ipsilateral knee
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Yukako
Middle name
Last name Shiraishi
Organization Zimmer Biomet G.K.
Division name Clinical Affairs
Zip code 105-0011
Address 15F, Sumitomo Fudosan Shibakoen Tower, 2-11-1, Shibakoen, Minato-ku, Tokyo, Japan
TEL 03-6402-6610
Email yukako.nishino@zimmerbiomet.com

Public contact
Name of contact person
1st name Yukako
Middle name
Last name Shiraishi
Organization Zimmer Biomet G.K.
Division name Clinical Affairs
Zip code 105-0011
Address 15F, Sumitomo Fudosan Shibakoen Tower, 2-11-1, Shibakoen, Minato-ku, Tokyo, Japan
TEL 03-6402-6610
Homepage URL
Email yukako.nishino@zimmerbiomet.com

Sponsor
Institute Zimmer Biomet G.K.
Institute
Department

Funding Source
Organization Zimmer Biomet G.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization 1
Address 1
Tel 1
Email 1

Secondary IDs
Secondary IDs YES
Study ID_1 CTRI/2014/09/005055
Org. issuing International ID_1 Clinical Trials Registry India
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 【国内】日本大学病院(東京都)、高知大学病院(高知県)
【インド】Fortis Health Care、All India Institute of Medical Sciences、Deenanath Mangeshkar Hospital & Research Center、Medica Superspecialty Hospital、Breach Candy & Khar Hinduja、SRM Hospital、Sant Parmanand Hospital、Nova Medical Centers & Capital Health
オーストラリア、シンガポール、韓国の実施施設は2015年2月時点で未定

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 11 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 1017
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
2014 Year 06 Month 09 Day
Date of IRB
2015 Year 01 Month 08 Day
Anticipated trial start date
2015 Year 02 Month 09 Day
Last follow-up date
2022 Year 12 Month 01 Day
Date of closure to data entry
2023 Year 12 Month 01 Day
Date trial data considered complete
2023 Year 12 Month 01 Day
Date analysis concluded
2023 Year 12 Month 01 Day

Other
Other related information Case Report Forms include the following information;
Demographic Information, Operative Information, X-ray/ CT Assessment, Clinical Assessment, Patient Reported Outcomes, Safety Information

Management information
Registered date
2015 Year 03 Month 11 Day
Last modified on
2019 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019473

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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