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Effect of local single-dose hormone on reconstruction of acute anterior cruciate ligament: a randomized controlled trial

Effect of local single-dose hormone on reconstruction of acute anterior cruciate ligament: a randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023422
Enrollment
Unknown
Registered
2019-05-27
Start date
2019-05-13
Completion date
Unknown
Last updated
2019-06-03

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

Conditions

Acute anterior cruciate ligament injury

Interventions

Experimental group:Intra-articular injection of betamethasone
Control group:Intra-articular injection of normal saline

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) aged 18-35 years, male or female; (2) acute phase ACL injury: anterior cruciate ligament rupture within 3 weeks of injury (anterior cruciate ligament - also known as anterior cruciate ligament, located in the knee joint The main function of the femur and the tibia is to limit the excessive displacement of the tibia. It cooperates with other structures in the knee joint to maintain the stability of the knee joint, so that the human body can complete various complicated and difficult lower limb movements; (3) at present, participating in sports activities, ACL injury occurs in sports injuries; (4) only one side of the knee joint is involved, the contralateral knee joint is normal, and the knee osteoarthritis is not satisfied; (5) the epiphysis has been closed.

Exclusion criteria

Exclusion criteria: (1) inflammatory joint disease (rheumatoid arthritis, psoriatic arthritis, etc.); (2) combined with any infection, including skin infections, or symptoms and signs of infection or fever; (3) Immune system defect status, such as diabetes, cancer, AIDS; (4) other conditions requiring immunosuppressive drugs; (5) long-term non-steroidal anti-inflammatory analgesic drugs; (6) history of knee joint hormone injection within 3 months after admission; (7) history of ipsilateral or contralateral knee surgery; (8) thrombosis; (9) severe liver and kidney dysfunction and cardiopulmonary dysfunction; (10) systemic fungal infection; (11) recent participation in other clinical trials; (12) patients who are allergic to betamethasone or other glucocorticoids or any of the components of this product.

Design outcomes

Primary

MeasureTime frame
Joint mobility;KOOS Score;SF-36;TAS Score;

Countries

China

Contacts

Public ContactHuang Gangyong

Huashan Hospital Affiliated to Fudan University

dormierhuang@163.com+86 15021796086

Outcome results

None listed

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