UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040940 |
|---|---|
| Receipt number | R000046743 |
| Scientific Title | Locomo-TKA |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2023/07/04 06:26:23 |
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Basic information
Public title
Impact of total knee arthroplasty on locomotive syndrome
Acronym
Impact of total knee arthroplasty on locomotive syndrome
Scientific Title
Locomo-TKA
Scientific Title:Acronym
Locomo-TKA
Region
| Japan |
Condition
Condition
osteoarthritis or rheumatoid arthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The concept of locomotive syndrome (LOCOMO), proposed by the Japanese Orthopaedic Association in 2007, is The term "locomotive" refers to a condition in which a person is at high risk of needing nursing care due to loss of mobility. Rheumatoid arthritis and osteoarthritis of the knee are some of the factors that contribute to LOCOMO. The purpose of the study is to clarify that the evaluation of locomotive activity improves with joint replacement surgery.
Basic objectives2
Others
Basic objectives -Others
A prospective observational study of mobility before and after knee replacement surgery (cross-sectional and longitudinal)
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in locomotive degree before and one year after total knee arthroplasty
Key secondary outcomes
(1) Identification of factors associated with changes in locomotive degree (e.g., surgical invasion, age, muscle cross-sectional area, limb muscle mass)
(2) Changes in the amount and quality of muscle cross-sectional area before and after surgery
(3) Correlation between change in muscle cross-sectional area and change in DXA value
(4) Correlation of locomotive degree, frailty and sarcopenia
5) Relationship between preoperative muscloskeletal ultrasound findings of meniscus and clinical assessment.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with rheumatoid arthritis or osteoarthritis of the knee who have undergone total knee arthroplasty In the orthopedic surgery department of Saiseikai Nakatsu Hospital.
Key exclusion criteria
Those who
-have been diagnosed with dementia
-have a history of cerebrovascular disease
-have coexisting hip or ankle joint disorders
-The motor function test is considered dangerous.
-are deemed inappropriate by the doctor in charge
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | INUI |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Orthopaedic Surgery
Zip code
530-0012
Address
2-10-39 Shibata Kita-ku, Osaka
TEL
06-6372-0333
k_inui2@nakatsu.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | INUI |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Orthopaedic Surgery
Zip code
530-0012
Address
2-10-39 Shibata Kita-ku, Osaka
TEL
06-6372-0333
Homepage URL
http://www.nakatsu.saiseikai.or.jp/
k_inui2@nakatsu.saiseikai.or.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Osaka Saiseikai Nakatsu Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Committee of Osaka Saiseikai Nakatsu Hospital
Address
2-10-39 Shibata Kita-ku, Osaka
Tel
06-6372-0333
seikei.ishijimu@nakatsu.saiseikai.or.jp
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
| 2020 | Year | 07 | Month | 01 | 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
220
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1)Basic patient information: age, gender, diagnosis, height, weight, comorbidities, past history (diabetes, stroke, osteoporosis, depression, and dementia), sports history, knee pain prevalence, and rheumatoid arthritis disease activity composite assessment.
(2) Evaluation of knee function: presence of hip and ankle joints disorder, JOA score, KSS, range of motion, quadriceps Muscle MMT
(3) Blood test results: CBC, AST, ALT, serum Cre, eGFR, CRP, LDH, ALP, CK, TP, Alb, 25OH-VitD
(4) X-ray: rheumatoid arthritis (Larsen's classification) osteoarthritis (KL classification, FTA, lateral thrust)
(5) CT images: evaluation of cross-sectional area and quality of the quadriceps muscle
(6) Dual-energy X-ray absorptiometry : whole body mode and proximal femur
(7) Joint echo test: evaluation of synovitis and meniscus deviation
(8) Surgery: operation time, blood loss, special note
The following items are new information to be obtained (physical ability tests and questionnaires)
(1) Locomotive degree test (stand up test, 2 step test, locomotive 25)
(2) Flail evaluation (J-CHS)
(3) Sarcopenia assessment
(4)EQ-5D-5L
[Statistical analysis method]
Primary endpoint: Multivariate analysis of change in locomotive force between preoperative and 1 year postoperative, including relevant factors.
Secondary endpoints: Appropriate statistical methods, such as multivariate analysis, will be performed for each item as appropriate.
In both cases, cases of bilateral knee surgery will be analyzed by stratifying concurrent surgery and surgery at different times.
Management information
Registered date
| 2020 | Year | 06 | Month | 29 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046743
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