Status:
UNKNOWN
The Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction
Lead Sponsor:
Central South University
Collaborating Sponsors:
Rejoin Hangzhou Martins Medical Equipment Co., Ltd.
Conditions:
PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 seconda...
Eligibility Criteria
Inclusion
- 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
- Do not meet the diagnostic criteria of anterior cruciate ligament injury;
- With posterior cruciate ligament fracture at the same time;
- X-ray showed a significant degeneration of the knee (more than four degrees of cartilage injury);
- Knee flexion less than 90 degree;
- Abnormal body anatomy;
- Pregnant, breast-feeding or subjects who plan to become pregnant;
- Serious osteoporosis, malignant tumors;
- Allergic to implant materials;
- Patients with severe malnutrition who can not tolerate surgery;
- Severe coagulopathy, such as hemophilia;
- Immunodeficiency diseases, including those requiring long-term use of immunosuppressive agents;
- The injured knee has a wide range of skin diseases;
- Serious obese patients (BMI\> 35);
- Patients with severe mental illness can not cooperate with postoperative rehabilitation and patients with severe cardiopulmonary disease can not tolerate surgery;
- Ipsilateral lower extremity received surgery within the past year;
- Has participated in any other clinical trial in the past three months;
- Can not comply with the requirements of the study;
- Those who the investigator thinks they are inappropriate.
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03342222
Start Date
November 20 2017
End Date
November 20 2019
Last Update
April 30 2018
Active Locations (1)
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1
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410008