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A prospective, multicenter, randomized, single-blind, parallel, positive-controlled, non-inferiority clinical trial to evaluate the safety and efficacy of interfacial screws for anterior cruciate ligament (ACL) reconstruction

A prospective, multicenter, randomized, single-blind, parallel, positive-controlled, non-inferiority clinical trial to evaluate the safety and efficacy of interfacial screws for anterior cruciate ligament (ACL) reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057545
Enrollment
Unknown
Registered
2022-03-14
Start date
2016-10-01
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Anterior cruciate ligament (ACL) reconstruction

Interventions

Experimental group:interference screw
Control group:biosure PK interference screw

Sponsors

Peking Union Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 60 years; 2. Patients with conditions suitable for anterior cruciate ligament reconstruction (determined by preoperative imaging data); 3. All patients underwent preoperative screening of anterior drawer test, axial shift test and Lachman test, and were diagnosed as patients with unilateral ACL injury of knee joint requiring surgical intervention through direct arthroscopy during surgery; 4. Contralateral knee joint function was normal (the investigator made a comprehensive judgment based on the patient's medical history and physical examination results); 5. Voluntary informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined with medial and lateral collateral ligament injury (except surgical intervention); 2. X-ray and MRI showed obvious degeneration of knee joint, with cartilage injury above grade IV; 3. The knee flexion Angle of the affected side is less than 100 degree due to old injuries; 4. Patients with anatomical abnormalities that do not qualify for surgery; 5. Patients of childbearing age who are pregnant, breastfeeding or planning to become pregnant; 6. After internal fixation or reconstruction of knee fracture; 7. History of osteoporosis and malignancy; 8. Have a history of allergy to test instrument materials; 9. Severe coagulation dysfunction; 10. A history of immunodeficiency disorders, including patients who must use immunosuppressant drugs for long periods of time; 11. Patients with extensive skin diseases on the injured limb; 12. Patients with a history of severe mental illness who cannot cooperate with postoperative rehabilitation treatment; 13. Participated in any other clinical trials within the past three months; 14. Unable to comply with the requirements of the research program; 15. Patients on hormonal and immunological agents; 16. Patients with abnormal renal function; 17. Patients considered unsuitable for inclusion in this clinical study by other researchers.

Design outcomes

Primary

MeasureTime frame
Fixed efficiency;

Secondary

MeasureTime frame
Lysholm knee score;IKDC scoring questionnaire;

Countries

China

Contacts

Public ContactWeng Xisheng

Peking Union Hospital, Chinese Academy of Medical Sciences

wengxshlc@163.com+86 13366200018

Outcome results

None listed

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