UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044766 |
|---|---|
| Receipt number | R000051130 |
| Scientific Title | Diagnostic accuracy of physical examination tests for suspected acute anterior cruciate ligament injury: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2021/07/06 |
| Last modified on | 2022/05/19 16:39:48 |
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Basic information
Public title
Diagnostic accuracy of physical examination tests for suspected acute anterior cruciate ligament injury: A systematic review and meta-analysis
Acronym
Diagnostic accuracy of physical examination tests for suspected acute anterior cruciate ligament injury: A systematic review and meta-analysis
Scientific Title
Diagnostic accuracy of physical examination tests for suspected acute anterior cruciate ligament injury: A systematic review and meta-analysis
Scientific Title:Acronym
Diagnostic accuracy of physical examination tests for suspected acute anterior cruciate ligament injury: A systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to perform a systematic review and meta-analysis of original research studies that involved diagnostic accuracy of four physical examination tests for ACL injury in an acute setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diagnostic test accuracy of Lachman, anterior drawer, pivot-shift, and Lever sign tests.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) original articles in English or Japanese
(2) single-gate studies, such as prospective cohort and cross-sectional studies in acute settings
(3) reported findings that enabled the calculation of the number of true-positive (TP), true-negative (TN), false-positive (FP), and false-negative (FN) values
(4) reported data of adolescents and young adults
(5) reported findings of partial or complete ACL injury
(6) evaluated MRI and/or arthroscopy as the reference standard.
Key exclusion criteria
(1) participants who had undergone surgery in knee joints affected by ACL injury
(2) participants with other associated diseases such as osteoarthritis and meniscus injury
(3) diagnosis determined using questionnaires
(4) diagnosis determined using devices
(5) laxity.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shigeharu |
| Middle name | |
| Last name | Tanaka |
Organization
Kanagawa University of Human Services
Division name
Department of Rehabilitation
Zip code
238-0013
Address
1-10-1 Heisei-cho, Yokosuka, Kanagawa
TEL
046-828-2792
tanaka-d4k@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | Shigeharu |
| Middle name | |
| Last name | Tanaka |
Organization
Kanagawa University of Human Services
Division name
Department of Rehabilitation
Zip code
238-0013
Address
1-10-1 Heisei-cho, Yokosuka, Kanagawa
TEL
046-828-2792
Homepage URL
tanaka-d4k@kuhs.ac.jp
Sponsor or person
Institute
Kanagawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Kanagawa University of Human Services
Address
1-10-1 Heisei-cho, Yokosuka, Kanagawa
Tel
046-828-2792
tanaka-d4k@kuhs.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
| 2021 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
0
Results
Eight studies were included in this review. The pooled sensitivities were 0.79, 0.78, 0.55, and 0.82 in the Lachman, anterior drawer, pivot shift, and lever sign tests, respectively, and the pooled specificities were 0.91, 0.91, 0.96, and 0.88, respectively. The lever sign test had the lowest negative LR (0.21) and the pivot shift test had the highest positive LR (11.60). The area under the curve for the four physical examinations was > 0.70.
Results date posted
| 2022 | Year | 05 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
None
Participant flow
None
Adverse events
None
Outcome measures
None
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The languages used for the search were English and Japanese. The electronic search was conducted using the following databases: PubMed, MEDLINE (Medical Literature Analysis and Retrieval System Online), CINAHL (Cumulative Index to Nursing and Allied Health Literature), Web of Science, and Ichushi.
Management information
Registered date
| 2021 | Year | 07 | Month | 06 | Day |
Last modified on
| 2022 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051130
