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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04957706
Other study ID # LM2019116
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 1, 2022

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact xingyue niu, M.D.
Phone 13126710633
Email Meteornnn@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

For patients with anterior cruciate ligament rupture, the existing physical examinations have certain limitations. The researchers improved the traditional anterior drawer test in clinical work, maintained the flexion of the knee and flexion of the hip, and observed the displacement of the tibia. Good diagnostic effect, but no research statistics. The purpose of this study is to explore the effectiveness of the 90° of hip flextion anterior drawer test in the diagnosis of anterior cruciate ligament rupture.


Description:

A total of 300 hospitalized patients who were diagnosed with anterior cruciate ligament rupture by MR and prepared for anterior cruciate ligament reconstruction were included, of which 150 cases were injured in the acute phase (within 2 months after the injury) and the chronic phase (more than 2 months after the injury). After the patient was admitted to the hospital, the patients were sequentially subjected to the 90° anterior drawer test, Lachman test, pivot-shift test, and anterior drawer test. The examination results were recorded. Compare the effectiveness of different physical examinations in diagnosing the anterior cruciate ligament. The patient's age, gender, injury time, BMI, the type of ACL rupture in the surgical records, and whether meniscus or cartilage damage were combined were counted. Regression analysis was used to evaluate the influencing factors of the modified anterior drawer test to correctly diagnose the rupture of the ACL.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date September 1, 2022
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - (1)ages between 18 and 60 years old. (2) Inpatients diagnosed with unique anterior cruciate ligament rupture and ready for anterior cruciate ligament reconstruction. (3) no combined injuries. Exclusion Criteria: - (1) The patient is younger than 18 years old or older than 60 years old, (2) multiple ligament injuries of the knee joint are suspected, and (3) combined fractures are suspected.

Study Design


Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Injuries
  • Anterior Cruciate Ligament Rupture
  • Rupture

Intervention

Diagnostic Test:
anterior drawer test at 90° of hip flexion
anterior drawer test at 90° of hip flexion
Lachman test
Lachman test
anterior drawer test
anterior drawer test
pivot-shift test
pivot-shift test

Locations

Country Name City State
China Peking university third hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary anterior drawer test at 90° of hip flexion anterior drawer test at 90° of hip flexion 1 week after injury
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