Diagnostic Study of ACL Rupture With Anterior Drawer Test at 90° of Hip Flexion

Diagnostic Study of Anterior Cruciate Ligament Rupture With Anterior Drawer Test at 90° of Hip Flexion

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Diagnostic test: anterior drawer test at 90° of hip flexion; Diagnostic test: Lachman test; Diagnostic test: anterior drawer test; Diagnostic test: pivot-shift test

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: xingyue niu, M.D.; Phone Number: 13126710633; Email: Meteornnn@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
      • Contact: yingfang ao, M.D.; Phone Number: 13910125935; Email: aoyingfang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient are from Peking University Third Hospital

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute injury; injury ≤ 2 months	Diagnostic test: anterior drawer test at 90° of hip flexion; anterior drawer test at 90° of hip flexion; Diagnostic test: Lachman test; Lachman test; Diagnostic test: anterior drawer test; anterior drawer test; Diagnostic test: pivot-shift test; pivot-shift test
Chronic injury; injury > 2 months	Diagnostic test: anterior drawer test at 90° of hip flexion; anterior drawer test at 90° of hip flexion; Diagnostic test: Lachman test; Lachman test; Diagnostic test: anterior drawer test; anterior drawer test; Diagnostic test: pivot-shift test; pivot-shift test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anterior drawer test at 90° of hip flexion	anterior drawer test at 90° of hip flexion	1 week after injury

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: yingfang ao, M.D., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: LM2019116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No