UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027849 |
|---|---|
| Receipt number | R000031599 |
| Scientific Title | The effect of component gap balance on post-operative patient satisfaction and functional outcomes in primary total knee arthroplasty |
| Date of disclosure of the study information | 2017/06/21 |
| Last modified on | 2021/10/27 11:06:29 |
* 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
The effect of component gap balance on post-operative patient satisfaction and functional outcomes in primary total knee arthroplasty
Acronym
The effect of component gap balance on post-operative patient satisfaction and functional outcomes in primary total knee arthroplasty
Scientific Title
The effect of component gap balance on post-operative patient satisfaction and functional outcomes in primary total knee arthroplasty
Scientific Title:Acronym
The effect of component gap balance on post-operative patient satisfaction and functional outcomes in primary total knee arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of medial component gap difference between extension and flexion for post-operative patient satisfaction and functional outcomes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the effect of medial component gap difference between extension and flexion for post-operative patient satisfaction and functional outcomes
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.The subject requires a primary total knee replacement
2.The subject is between 20 years old to 80 years old
3.The subject is diagnosed as osteoarthritis
4.The subject has intact collateral ligament
5.The subject has signed the IRB approved, study specific informed patient consent form
6.The subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation
Key exclusion criteria
1.The subject is pregnant
2.The subject has inflammatory arthritis
3.The subject is morbidly obese
4.The subject has had unicompartmental arthroplasty, high tibial osteotomy, femoral osteotomy and/or joint fusion
5.The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device
6.The subject has a systemic or metabolic disorder leading to progressive bone deterioration
7.The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements
8.The patient has a deformity which will require the use of stems, wedges or augments
9.The subject has an active or suspected latent infection in or about the knee joint
10.The patient who are inappropriate for participating in the study in the judgment of the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takagi |
Organization
Showa University Fujigaoka Hospital
Division name
Orthopaedics
Zip code
Address
1-30, Fujigaoka, Aoba-ku, Yokohama, Kanagawa Pref.
TEL
045-971-1151
izn00067@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Motohashi |
Organization
Stryker Japan K.K.
Division name
Clinical Affairs
Zip code
Address
2-6-1, Koraku, Bunkyo-ku, Tokyo
TEL
03-6894-8394
Homepage URL
NSKclinicaltrial@stryker.com
Sponsor or person
Institute
Stryker Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Stryker Japan K.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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 21 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate medial gap difference between flextion-extension and post clinical outcome in TKA subject with Triathlon total knee system.
Management information
Registered date
| 2017 | Year | 06 | Month | 21 | Day |
Last modified on
| 2021 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031599
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
