UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010221 |
|---|---|
| Receipt number | 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 12:55:15 |
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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
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
akira.kashima@zimmer.com
Sponsor or person
Institute
Zimmer K.K.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011971
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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