UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032126 |
|---|---|
| Receipt number | R000036654 |
| Scientific Title | Clinical study in the quantitative evaluation of rotatory stability using the mulrtiple axes sensor in the anterior cruciate ligament injury of the knee joint |
| Date of disclosure of the study information | 2018/04/06 |
| Last modified on | 2024/10/09 10:58:49 |
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Basic information
Public title
Clinical study in the quantitative evaluation of rotatory stability using the mulrtiple axes sensor in the anterior cruciate ligament injury of the knee joint
Acronym
The quantitative evaluation of rotatory stability in the ACL-injured knee
Scientific Title
Clinical study in the quantitative evaluation of rotatory stability using the mulrtiple axes sensor in the anterior cruciate ligament injury of the knee joint
Scientific Title:Acronym
The quantitative evaluation of rotatory stability in the ACL-injured knee
Region
| Japan |
Condition
Condition
ACL injury of the knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate quantitatively of the rotatory atbility using the multiplke axes sensor in the ACL-injured kenn joint
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rotatory atbility in the kenn joint
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with
1.ACL-injured unilateral knee and normal contralateral knee
2.indication for the ACL reconstructive suregry
Key exclusion criteria
Patients with
1. a concomitantmeniscal injury needed resection
2. other ligament injuries more than grade 2
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakamura |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Orthopaedic Suregery
Zip code
860-8556
Address
1-1-1, Honjyo, Chuo-ku, Kumamoto-City
TEL
096-373-5226
h@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakamura |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Orthopaedic Suregery
Zip code
860-8556
Address
1-1-1, Honjyo, Chuo-ku, Kumamoto-City
TEL
096-373-5226
Homepage URL
h@kumamoto-u.ac.jp
Sponsor or person
Institute
Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Suregery, Faculty of Life Sciences, Kumamoto University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Life Sciences, Kumamoto University
Address
1-1-1, Honjyo, Chuo-ku, Kumamoto-City
Tel
096-373-5657
ski-shien@jimu.kumamoto-u.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
| 2018 | Year | 04 | Month | 06 | Day |
Related information
URL releasing protocol
UMIN000032126
Publication of results
Unpublished
Result
URL related to results and publications
The 29th Annual Research Meeting of the Japanese Orthopedic Association
Number of participants that the trial has enrolled
24
Results
[Results] The At (mm), An (degree), Av (degree/s), and Ac (degree/s2) values for Group A and Group N were 1.2 and 0.4 (p=0.028), 3.3 and 1.6 (p=0.052), 39 and 1 9 (p=0.038), and 370 and 279 (p=0.345), respectively. The A values were 0.74, 0.54, 0.80, and 0.63, respectively, and the angular velocity and the forward displacement had high diagnostic performance.
Results date posted
| 2024 | Year | 10 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
24 patients with unilateral ACL injury and 10 healthy subjects
Participant flow
[Methods] We measured the amount of anterior displacement of the tibia relative to the femur (At: center point of the joint), the angle of rotation (An), angular velocity (Av), and angular acceleration (Ac) of the tibia relative to the femur that occurs between 15 degrees and 45 degrees of flexion in both knees in 24 patients with unilateral ACL injury and 10 healthy subjects during the Pivot-shift test while awake, using MCICS and calculated the difference between the healthy and diseased groups (A group: difference between the left and right in healthy subjects; N group). As in the previous study, MCICS set 6 measurement points (3 reference points and 3 virtual reference points) on the thigh and lower leg respectively, and detected the position information of the 12 total points using 3 infrared cameras (100Hz, Anima Corporation) and measured it using PC analysis. For each measurement item, we examined the comparison between the two groups (p-value) and the AUC value (A value) in ROC analysis.
Adverse events
none
Outcome measures
[Methods] We measured the amount of anterior displacement of the tibia relative to the femur (At: center point of the joint), the angle of rotation (An), angular velocity (Av), and angular acceleration (Ac) of the tibia relative to the femur that occurs between 15 degrees and 45 degrees of flexion in both knees in 24 patients with unilateral ACL injury and 10 healthy subjects during the Pivot-shift test while awake, using MCICS and calculated the difference between the healthy and diseased groups (A group: difference between the left and right in healthy subjects; N group). As in the previous study, MCICS set 6 measurement points (3 reference points and 3 virtual reference points) on the thigh and lower leg respectively, and detected the position information of the 12 total points using 3 infrared cameras (100Hz, Anima Corporation) and measured it using PC analysis. For each measurement item, we examined the comparison between the two groups (p-value) and the AUC value (A value) in ROC analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 19 | 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
under examination
Management information
Registered date
| 2018 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036654
