UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048295 |
|---|---|
| Receipt number | R000055037 |
| Scientific Title | Factors Influencing Falls After Total Knee Arthroplasty -a prospective observational study- |
| Date of disclosure of the study information | 2022/07/07 |
| Last modified on | 2023/01/04 09:37:26 |
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Basic information
Public title
Factors Influencing Falls After Total Knee Arthroplasty
-a prospective observational study-
Acronym
Factors Influencing Falls After Total Knee Arthroplasty
-a prospective observational study-
Scientific Title
Factors Influencing Falls After Total Knee Arthroplasty
-a prospective observational study-
Scientific Title:Acronym
Factors Influencing Falls After Total Knee Arthroplasty
-a prospective observational study-
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to investigate factors affecting falls in patients with osteoarthritis of the knee one year after total knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fall(From the period of TKA to one year postoperatively)
Key secondary outcomes
Toe grasp strength, knee extension strength, PROMs, descriptive statistics
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosis of osteoarthritis of the knee, able to walk before and one year after surgery, Primary TKA, and consent to participate in the study
Key exclusion criteria
Rheumatoid arthritis, osteonecrosis of the medial condyle of the femur, diagnosed ankle joint (big toe or OA), flexion problems of both toes, neuromuscular disease, severely impaired basic movements such as walking, severe depression or dementia that are difficult to evaluate in our hospital, failure to follow up one year after surgery.
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Mawarikado |
Organization
Nara Medical University
Division name
Graduate School of Medicine, Musculoskeletal Reconstructive Surgery
Zip code
634-8521
Address
840 Shijocho, Kashihara, Nara, Japan
TEL
0744-22-3051
K115877@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Mawarikado |
Organization
Nara Medical University
Division name
Graduate School of Medicine, Musculoskeletal Reconstructive Surgery
Zip code
Graduate School of Medicine, Musculoskeletal Recon
Address
840 Shijocho, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
K115877@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
Nara Medical University
Address
840 Shijocho, Kashihara, Nara, Japan
Tel
0744-22-3051
K115877@naramed-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-04-21-007
Org. issuing International ID_1
2020-04-21-007
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
高清会 香芝旭ヶ丘病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 07 | 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
170
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
Main results already published
Date of protocol fixation
| 2020 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 06 | Day |
Other
Other related information
Approved by the Ethics Committee in April 2020. Observation of the target patients started in May of the same year. The number of subjects calculated in advance, 170, reached the end of June 2022. Therefore, the follow-up was completed at that point.
Management information
Registered date
| 2022 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055037
