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NCT Number: NCT05584020

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Xuesong Dai, Doctor

CONTACT

+8613777882818

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with anterior cruciate ligament tear clearly identified by imaging or intraoperative microscope, Sherman grade I, II; planned surgery within 3 weeks after injury
  • Basic reading and writing skills, and barrier-free communication
  • A smartphone, can use WeChat or be able to learn
  • Patients give informed consent, and sign the informed consent form, and the process must meet the requirements of GCP

Exclusion criteria

  • Combined with other knee joint injuries (posterior cruciate ligament injury, patellar dislocation, osteoarthritis, etc.)
  • Suffering from systemic immune diseases;
  • Existing other knee joint diseases or inflammatory diseases, including osteoarthritis, cervical spine disease, rheumatoid arthritis, fibromyalgia, polymyalgia rheumatica, etc.
  • Patients who have received local hormone injection within 3 months;
  • Those who have participated in clinical trials or are undergoing other clinical trials within 3 months before screening
  • Those who have serious primary cardiovascular disease, lung disease, endocrine and metabolic disease or serious diseases that affect their survival, such as tumor or AIDS, the researchers believe that they are not suitable for selection
  • Patients with severe liver disease, kidney disease, and hematological disease, such as renal function exceeding the upper limit of the normal value, and liver function exceeding 2 times the upper limit of the normal value;
  • Suffering from viral hepatitis, infectious diseases, severe abnormal blood coagulation mechanism and other Diseases that the researchers consider inappropriate for surgery
  • Women who are pregnant or breastfeeding, or who plan to become pregnant during the follow-up period, those who have a positive urine human chorionic gonadotropin test result before sampling; menstruating women should wait until the end of menstruation before surgery;
  • Severe neurological and mental disorders Disease patients;
  • Suspected or actual history of alcohol and drug abuse.

Treatment and study plan

ACL Repair

Procedure

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.

ACL reconstruction

Procedure

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.

Primary outcomes

  1. IKDC score

    Time frame: 1 year

    The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

    Efficiency of 1 year after operation=Sum of Items/Maximum Possible Score *100

Secondary outcomes

  1. IKDC score

    Time frame: 3 months

    The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).

    Efficiency of 3 months after operation=Sum of Items/Maximum Possible Score *100

  2. IKDC score

    Time frame: 6 months

    The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).

    Efficiency of 6 months after operation=Sum of Items/Maximum Possible Score *100

  3. IKDC score

    Time frame: 2 years

    The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).

    Efficiency of 2 years after operation=Sum of Items/Maximum Possible Score *100

Study contacts

Contact information is provided by the study sponsor or research team.

Xuesong Dai, Doctor

CONTACT

[email protected]

+8613777882818

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury: a Multicenter Randomized Controlled Surgical Trial

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Oct 18, 2022
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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