UMIN-CTR Clinical Trial

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
Email	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
Email	tanaka-d4k@kuhs.ac.jp

Sponsor
Institute	Kanagawa University of Human Services
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051130