UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055263 |
|---|---|
| Receipt number | R000063147 |
| Scientific Title | Research on gait in knee osteoarthritis |
| Date of disclosure of the study information | 2024/08/19 |
| Last modified on | 2024/08/16 20:54:17 |
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Basic information
Public title
Improvement of joint kinematics and mechanical loading dur-ing a walking cycle in the early postoperative period after total knee arthroplasty
Acronym
Improvement of joint kinematics and mechanical loading dur-ing a walking cycle in the early postoperative period after total knee arthroplasty
Scientific Title
Research on gait in knee osteoarthritis
Scientific Title:Acronym
Research on gait in knee osteoarthritis
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to verify the improvement of gait function in the early postoperative period using gait analysis including variables such as varus thrust, ground reaction force, centre of pressure, and joint moment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain score, Range of Motion, and femorotibial angle, Walking speed, stride length, Knee joint movement, varus thrust, ground reaction force, centre of pressure, and joint moment
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
| 64 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with knee osteoarthritis by an orthopedic surgeon and scheduled for total knee arthroplasty.
Key exclusion criteria
The exclusion criteria for this study were prior history of rheumatoid arthritis, surgery on the knee joint, trauma, or central neuropathy. Patients who had difficulty walking on their own were also excluded.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | TAKASHi |
| Middle name | |
| Last name | FUKAYA |
Organization
Tsukuba International University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
300-0051
Address
6-8-33 Manabe, Tsuchiura, Ibaraki, Japan
TEL
0298266622
t-fukaya@tius.ac.jp
Public contact
Name of contact person
| 1st name | TAKASHI |
| Middle name | |
| Last name | FUKAYA |
Organization
Tsukuba International University
Division name
Tsukuba International University
Zip code
300-0051
Address
6-8-33 Manabe, Tsuchiura, Ibaraki, Japan
TEL
0298266622
Homepage URL
t-fukaya@tius.ac.jp
Sponsor or person
Institute
Tsukuba International University
Institute
Department
Personal name
TAKASHI FUKAYA
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Ibaraki, Japan
Tel
0298884000
t-fukaya@tius.ac.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
| 2024 | Year | 08 | Month | 19 | 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
12
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
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The varus thrust was improved by the alignment correction after TKA. The reduction of the GRF in the lateral direction suggests that the mechanical load by the lateral shear force was reduced. In addition, the knee joint extension function improved and the vertical component of the GRF was reduced after TKA, indicating a reduction of the mechanical load in the mid-stance phase.
Management information
Registered date
| 2024 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063147
