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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040940
Receipt No. R000046743
Scientific Title Locomo-TKA
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/29

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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 medial 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
Email 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/
Email k_inui2@nakatsu.saiseikai.or.jp

Sponsor
Institute Department of Orthopaedic Surgery, Osaka Saiseikai Nakatsu Hospital
Institute
Department

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
Email 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
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
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
2020 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046743

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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