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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020380
Receipt No. R000023536
Scientific Title The study of prosthesis design in total knee arthroplasty
Date of disclosure of the study information 2016/01/04
Last modified on 2015/12/28

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Basic information
Public title The study of prosthesis design in total knee arthroplasty
Acronym The study of prosthesis design in TKA
Scientific Title The study of prosthesis design in total knee arthroplasty
Scientific Title:Acronym The study of prosthesis design in TKA
Region
Japan

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

Objectives
Narrative objectives1 To compare among intraoperative patellofemoral joint pressure, subjective clinical score and intraoperative knee kinematics in total knee arthroplasty
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraoperative patellofemoral joint contact pressure obtained by using different patella component design.
Key secondary outcomes Subjective and objective clinical outcomes (p.o. 1y and 2y)

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 Maneuver
Interventions/Control_1 Intraoperative measurement by using different design of component trial.( four times)
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Total knee arthroplasty will be performed for primary OA
2. Patient has given consent to participate in the study.
4. more than 20 years old and less than 80 years old
Key exclusion criteria 1. Bone quality (tibia and femur) is insufficient.
2. Patient is immunosuppressed or has an autoimmune immunodeficient disorder.
3. Patient has an autoimmune disorder.
4. Patient has had major, non-arthroscopic surgery to the study knee.
5. Patient has an active, local infection or systemic infection.
6. Patient has a physical, emotional or neurological condition that would compromise compliance with postoperative rehabilitation and follow up.
7. Patient has hip inflammatory arthritis or performed THA.
8. Lateral knee OA
9. Patient is pregnant or plans to pregnant during course of study.
10. Patient is on workman's compensation.
11. Serious medical infirmity.
12. Symptomatic spinal disease.
13. more than 80 years old
Target sample size 64

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiro Onodera
Organization Hokkaido University, Sapporo, Japan
Division name Department of Orthopaedic Surgery
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo
TEL 011-706-5935
Email tomozou@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Onodera
Organization Hokkaido University, Sapporo, Japan
Division name Department of Orthopaedic Surgery
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo
TEL 011-706-5935
Homepage URL
Email tomozou@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University, Sapporo, Japan
Institute
Department

Funding Source
Organization Hokkaido University, Sapporo, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 04 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 Preinitiation
Date of protocol fixation
2015 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 28 Day
Last modified on
2015 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023536

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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