UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016779 |
|---|---|
| Receipt number | 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 | 2024/09/05 07:56:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
yukako.shiraishi@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
yukako.shiraishi@zimmerbiomet.com
Sponsor or person
Institute
Zimmer Biomet G.K.
Institute
Department
Personal name
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
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
Completed
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
| 2024 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019473
