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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010221
Receipt No. R000011971
Scientific Title A randomized, prospective controlled pilot study between UKA and TKA
Date of disclosure of the study information 2013/03/12
Last modified on 2015/03/27

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Basic information
Public title A randomized, prospective controlled pilot study between UKA and TKA
Acronym UKA/TKA Study
Scientific Title A randomized, prospective controlled pilot study between UKA and TKA
Scientific Title:Acronym UKA/TKA Study
Region
Japan

Condition
Condition Bilateral Medial Knee Osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare between Unicompartmental Knee Arthroplasty (UKA) and Total Knee Arthroplasty (TKA) on patient satisfaction and clinical outcomes for younger (20 to 70 years of age) Japanese patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 2011 Knee Society Score
Key secondary outcomes Radiographic Assessment, Clinical Assessments and Safety Assessment

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Perform UKA first
Interventions/Control_2 Perform TKA first
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1). Patient is 20 to 70 years of age at the Informed Consent (IC), inclusive
2). Both males and females
3). Patient qualifies for bilateral primary medial UKA due to bilateral unicompartmental knee osteoarthritis (Do not want to randomly implant a UKA in a patient who requires TKA)
4). Patient has more than 120 degree pre-op Range of Motion (ROM)
5). Patient expect load bearing ROM to be less than or equal to 155 degrees
6). Patient with flexion contracture less than 15 degree
7). Patient with preserved lateral compartment and patellofemoral joint
8). Patient with varus deformity less than 15 degree (Valgus deformities will be excluded from this study)
9). Patient with not significant obesity defined with a Body Mass Index (BMI) of <40
10). Patient has no osteophyte in intercondylar notch
11). Patient has intact anterior cruciate ligaments
12). Patient is willing and able to provide the written IC by signing and dating the Independent Ethics Committee (IEC) approved IC form
13). Patient is willing and able to complete scheduled study procedures and follow-up evaluations
14). Japanese
Key exclusion criteria 1). Patient is currently participating in any other surgical intervention studies or pain management studies
2). Patient with previous history of infection in the affected joint and/or local/systemic infection that may affect the prosthetic joint
3). Patient with insufficient bone stock on femoral or tibial surfaces
4). Patient with skeletal immaturity
5). Patient with neuropathic arthropathy
6). Patient with chondrocalcinosis
7). Patient with osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
8). Patient with damage to the articular cartilage of the opposite compartment
9). Patient with inflammatory synovitis
10). Patient with eburnation in the patellofemoral joint
11). Patient with a stable, painless arthrodesis in a satisfactory functional position
12). Patient with severe instability secondary to the absence of collateral ligament integrity
13). Patient with an ulcer of the skin or a history of recurrent breakdown of the skin
14). Patient with history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
15). Patient has a known or suspected sensitivity or allergy to one or more of the implant materials
16). Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyonori Mizuno
Organization Anshin Hospital
Division name Orthopedic Surgery
Zip code
Address 4-12, Minatojima 1-chome, Minami-machi, Chuo-ku, Kobe, Hyogo 650-0047, Japan
TEL 078-304-5252
Email akira.kashima@zimmer.com

Public contact
Name of contact person
1st name
Middle name
Last name Akira Kashima
Organization Zimmer K.K.
Division name Clinical Affairs
Zip code
Address 1-17, Toranomon 4-chome Minato-ku, Tokyo, Japan
TEL 03-6402-6610
Homepage URL
Email akira.kashima@zimmer.com

Sponsor
Institute Zimmer K.K.
Institute
Department

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
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 あんしん病院(Anshin Hospital)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 12 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 Terminated
Date of protocol fixation
2012 Year 10 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 13 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 02 Month 28 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 05 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 12 Day
Last modified on
2015 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011971

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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