The Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction

Multi-center, Randomized, Open, Parallel, Noninferiority Clinical Trial to Evaluate the Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03342222

Enrollment

120

Registered

2017-11-14

Start date

2017-11-20

Completion date

2019-11-20

Last updated

2018-04-30

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

Conditions

PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction

Keywords

PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction

Brief summary

Anterior cruciate ligament (ACL) rupture is one of the most common injuries in sports medicine. ACL reconstructions are usually performed to restore the stability of knee joint and prevent the secondary meniscal and chondral lesions. 120 Subjects with ACL injury were randomly assigned to two groups for ACL reconstruction.Group one: tibial fixation with PEEK Interference Screws (Rejoin Hangzhou Martins Medical Equipment Co., Ltd.);Group two: tibial fixation with Biosure PK interference screw (Smith & Nephew plc). The subjects will be followed by 12 months after surgery for evaluations.Outcome measures included Lysholm score,IKDC, ADT,Lachman.

Interventions

DEVICEInterference Screws

tibial fixation for ACL reconstruction

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Voluntarily sign the informed consent form; Between the ages of 18 and 75; Positive ADT and positive Lachman test. Unilateral anterior cruciate ligament is confirmed by MRI (without posterior cruciate ligament injury or reconstruction); Tolerated for anterior cruciate ligament reconstruction surgery; Normal contralateral knee

Exclusion criteria

1. Do not meet the diagnostic criteria of anterior cruciate ligament injury; 2. With posterior cruciate ligament fracture at the same time; 3. X-ray showed a significant degeneration of the knee (more than four degrees of cartilage injury); 4. Knee flexion less than 90 degree; 5. Abnormal body anatomy; 6. Pregnant, breast-feeding or subjects who plan to become pregnant; 7. Serious osteoporosis, malignant tumors; 8. Allergic to implant materials; 9. Patients with severe malnutrition who can not tolerate surgery; 10. Severe coagulopathy, such as hemophilia; 11. Immunodeficiency diseases, including those requiring long-term use of immunosuppressive agents; 12. The injured knee has a wide range of skin diseases; 13. Serious obese patients (BMI\> 35); 14. Patients with severe mental illness can not cooperate with postoperative rehabilitation and patients with severe cardiopulmonary disease can not tolerate surgery; 15. Ipsilateral lower extremity received surgery within the past year; 16. Has participated in any other clinical trial in the past three months; 17. Can not comply with the requirements of the study; 18. Those who the investigator thinks they are inappropriate.

Design outcomes

Primary

Measure	Time frame
percentage of patients with Lysholm score more than 70 score	12 month

Secondary

Measure	Time frame
Lysholm score	1month; 3month; 6 month; 12 month
IKDC	1month; 3month; 6 month; 12 month
Anterior drawer test	1month; 3month; 6 month; 12 month
Lachman test	1month; 3month; 6 month; 12 month

Countries

China

Contacts

Primary ContactXi He, MD

hongbinlu@hotmail.com86-073189753059

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026