Clinical trial NCT03342222: The Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction
Official title: Multi-center, Randomized, Open, Parallel, Noninferiority Clinical Trial to Evaluate the Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction
Keywords: PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: Rejoin Hangzhou Martins Medical Equipment Co., Ltd.
First posted: 2017-11-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: percentage of patients with Lysholm score more than 70 score
timeFrame: 12 month
Secondary outcomes:
measure: Lysholm score
timeFrame: 1month; 3month; 6 month; 12 month
measure: IKDC
timeFrame: 1month; 3month; 6 month; 12 month
measure: Anterior drawer test
timeFrame: 1month; 3month; 6 month; 12 month
measure: Lachman test
timeFrame: 1month; 3month; 6 month; 12 month
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
Study officials:
References: