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A Randomized Controlled Study of Combined Anterior Cruciate Ligament and Anterolateral Structural Reconstruction for the Treatment of Anterior Cruciate Ligament Injuries with High Risk of Clinical Failure

A Randomized Controlled Study of Combined Anterior Cruciate Ligament and Anterolateral Structural Reconstruction for the Treatment of Anterior Cruciate Ligament Injuries with High Risk of Clinical Failure

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107282
Enrollment
Unknown
Registered
2025-08-07
Start date
2025-08-18
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior cruciate ligament injury

Interventions

Experimental group (ACLR + ALSR):ACLR+ALSR
Control group(ACLR+ALLR):ACLR+ALLR

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1: The clinical diagnosis is a primary unilateral anterior cruciate ligament injury, with the contralateral knee joint being normal 2: Age: 18-45 years old 3: Injury to surgery time: either chronic injury or acute injury (no limits) 4: Meeting at least one of the following criteria: a) Regularly participating in cutting and pivoting activities (such as basketball, football, skiing, etc.) before injury and expecting to return to sports b) A highly positive pivot shift test before surgery c) Generalized ligamentous laxity (Beighton score>=4) or genu recurvatum (>10°). d) Higher lateral posterior-inferior tibial slope (>=10.6°)) . 5: All reconstructions are performed using autologous tendons 6: Having certain subjective judgment and cognitive abilities, basic reading and writing skills, and being able to complete the selection and judgment of relevant outcome indicators 7: Signing the informed consent form

Exclusion criteria

Exclusion criteria: 1: Multiple ligament injuries (>=two ligament injuries, anterior cruciate ligament injuries combined with medial collateral ligament injuries that do not require repair and reconstruction are not excluded from the exclusion criteria, if anterior cruciate ligament injuries combined with collateral ligament injuries that require repair and reconstruction are excluded) 2: Severe osteochondral injury or arthritis of the knee joint 3: History of knee surgery 4: Patent epiphysis 5: The autologous tendon is too thin 6: Drug and/or alcohol abuse 7: Pregnant or planning to become pregnant and breastfeeding within the next year 8: The researchers determined that there are serious co-morbidities that may hinder the follow-up and conduct of the trial, such as uncontrolled HIV infection, opioid dependence, severe coronary artery disease, severe peripheral vascular disease, active cancer, chronic obstructive pulmonary disease, etc 9: Possibility of long-term residence abroad within the next year 10: Severe claustrophobia and other factors or contraindications that hinder MRI examination (e.g. implanted pacemakers, metal sutures, shrapnel or metal implants in the body, knees too large to use coils, etc.)

Design outcomes

Primary

MeasureTime frame
Clinical failure;

Secondary

MeasureTime frame
Score sheet assessment;Return-to-sport ratio;Radiological assessment;Single-leg hop function assessment;Functional assessment;Kinematic assessment;Adverse event;Patient satisfaction;

Countries

China

Contacts

Public ContactChen Jiebo

Shanghai Sixth People's Hospital

chenjiebodsm@hotmail.com+86 64369181

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026