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Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury

NCT05584020 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2022-10-18

No results posted yet for this study

Summary

Background: Arthroscopic anterior cruciate ligament(ACL) reconstruction is so far the gold standard for the treatment of ACL ruptures, but this technique still suffers from problems of tendon-bone healing, bone tunnel enlargement, bone resorption, a low rate of return to motion,etc. In recent years, due to the innovation of medical materials and surgical techniques, anterior cruciate ligament repair technology has returned to the field of vision of clinical doctors. This technique has the advantages of preserving the natural ligaments and their proprioceptive sensation, avoiding the bone injury of the tunnel and the complications of the donor site. However, there is still a lack of high-quality clinical randomized controlled trails to provide evidence of the effect of arthroscopic ACL repair.

Hypothesis: Arthroscopic ACL repair is comparable to ACL reconstruction in patients with ACL tears (Sherman grades I and II).

Study Design: This study was a prospective, multicenter, randomized, double-blinded, parallel-controlled, non-inferiority trial design. A total of 330 patients with ACL tears were randomly divided into 2 groups, and were randomly assigned to the experimental group (arthroscopic anterior cruciate ligament repair) and the control group (arthroscopic anterior cruciate ligament reconstruction) according to 1:1. Follow-up knee function and other scores were performed at 3 months, 6 months, 1 year, and 2 years after surgery, and the total study time is expected to be 3 years.

Conditions

  • Anterior Cruciate Ligament Injuries

Interventions

PROCEDURE

ACL Repair

Patients are undergoing arthroscopic anterior cruciate ligament repair. The native ACL is repaired using very strong sutures. This device is used to repair the native ACL and restore knee stability.

PROCEDURE

ACL Reconstruction

Patients are undergoing arthroscopic anterior cruciate ligament reconstruction. The torn ligament is removed and replaced with a band of tissue that usually connects muscle to bone. The graft tendon is taken from another part of your knee or from a deceased donor.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05584020 on ClinicalTrials.gov