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A Randomized Study Comparing Single-bundle Anterior Cruciate Ligament and Anterolateral Structure Reconstruction versus Double-bundle Anterior Cruciate Ligament and Anterolateral Structure Reconstruction

A Randomized Study Comparing Single-bundle Anterior Cruciate Ligament and Anterolateral Structure Reconstruction versus Double-bundle Anterior Cruciate Ligament and Anterolateral Structure Reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060134
Enrollment
Unknown
Registered
2022-05-19
Start date
2022-06-15
Completion date
Unknown
Last updated
2024-04-22

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

Group 1:Double-bundle Anterior Cruciate Ligament and Anterolateral Structure Reconstruction
Group 2:Single-bundle Anterior Cruciate Ligament and Anterolateral Structure Reconstruction

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 was primary unilateral anterior cruciate ligament injury, while the contralateral knee joint was normal; 2. Aged 18-45 years; 3. Injury time: old injury (more than 3 months); 4. Meet at least one of the following: (1) Regularly participate in stop-and-turn related sports (such as basketball, football, skiing, etc.) before injury and expect to return; (2) Preoperative axial displacement test was positive; (3) Multiple ligament relaxation (Beighton score >=4) or knee arthroflexion (> 10 degrees); (4) Posterior Angle of lateral tibial plateau >=10.6 degrees; 5. Autologous tendons were used for all reconstruction; 6. Have certain subjective judgment cognitive ability, basic reading and writing ability, and can complete the selection and judgment of relevant outcome indicators.

Exclusion criteria

Exclusion criteria: 1. Severe osteocartilage injury or arthritis of knee joint; 2. History of knee surgery; 3. Patent epiphysis; 4. Drug and/or alcohol abuse; 5. Those who are pregnant or plan to become pregnant in the next year or are breastfeeding; 6. The investigators judged that there were serious co-conditions that might hinder 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.; 7. The possibility of long-term residence abroad within the next year; 8. Severe claustrophobia and other factors or contraindications that hinder MRI examination (such as pacemaker implantation, metal sutures, shrapnel or metal implants in the body, knee too large to use a coil, etc.).

Design outcomes

Primary

MeasureTime frame
Clinical failure;

Secondary

MeasureTime frame
Lysholm Score;IKDC Score;Knee Motor Function Score;Tegner Score;K-SES Score;ACL-RSI Score;Knee Stability - steering Score;Radiological outcomes;Dual-fluro;Rate of return to play;Degree of satisfaction;Adverse events;

Countries

China

Contacts

Public ContactZhao Jinzhong

Shanghai Sixth People's Hospital

jzzhao@sjtu.edu.cn+86 18930177160

Outcome results

None listed

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