The Clinical Outcome of Anterior Cruciate Ligament Reconstruction

• Conditions: Anterior Cruciate Ligament Rupture

• Registration Number: NCT03984474
• Lead Sponsor: Peking University Third Hospital

Brief Summary

Retrospective cohort study. The investigators evaluated the early, middle and long term effects of different surgical methods of anterior cruciate ligament reconstruction on knee function.

In the evaluation, the investigators focused on the differences between different age groups, different genders and different basic motor states, the differences between early reconstruction and non-early reconstruction, and the differences in clinical outcomes of different surgical methods.

Detailed Description

Age 13-65 included. Only include isolated anterior cruciate ligament(ACL) rupture. Excluded revision surgery. Excluded bilateral ACL rupture. Excluded the contralateral ACL tear after surgery. 40 patients at least in each group.

Study Timeline

• Study Start: 2003-01-14
• Study First Submitted: 2019-04-29
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-10
• Last Update Submitted: 2019-06-10
• Study First Posted: 2019-06-13
• Last Update Posted: 2019-06-13
• Primary Completion: 2020-12-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

diagnosis of isolated anterior cruciate ligament rupture

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Exclusion Criteria

combined other ligament damage combined intraarticular injuries

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Knee Documentation Committee(IKDC) score	an average of 20 year	The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.
KT-2000 test	an average of 20 year	It is a kind of joint measuring instrument used to determine the anteroposterior stability of knee joint. The contrast between the uninjured side and the surgical measurement showed that the difference of ≤3mm was considered excellent.
Magnatic Resonance Imaging evaluation	an average of 20 year	All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).

Secondary Outcome Measures

Name	Time	Method
Skeletal force line and various angles by X-ray evaluation	an average of 20 year	X-ray was used to evaluate the skeletal force line and various angles of patients. Use Qvadriceps Angle to evaluate quadriceps force line and patellar ligament force line. The normal Angle is 18-22° for the adult standing position.Above or below this range is considered abnormal.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China