Status:
UNKNOWN
Absorbable Interface Screw Clinical Trial
Lead Sponsor:
Peking University Third Hospital
Conditions:
Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Validation of the safety and efficacy of absorbable interface screws for clinical use
Detailed Description
Interface screws are divided into metal screws and absorbable screws. Since metal screws cut tendon grafts, absorbable interface screws are now mostly selected. At present, the materials of absorbable...
Eligibility Criteria
Inclusion
- ① Before surgery, subjects or guardians are willing and able to sign the informed consent;
- Patients aged 18 to 80 (including 18 and 80 years old), regardless of gender;
- Patients who meet the diagnostic criteria for anterior cruciate ligament rupture of the knee joint and have no contraindications to implantation;
- The patient's bones are mature;
- Good compliance, willing and able to conduct follow-up observation as required.
Exclusion
- ① Subjects who have participated in other clinical studies of drugs, biological agents or medical devices before being selected and did not reach the primary study endpoint;
- The patient is known to have a history of allergy to one or more implanted materials;
- Those who are physically weak or cannot tolerate surgery due to other diseases of the body;
- Active infection in the knee joint or other parts of the body; ⑤ Those with other ligament injury and/or meniscus injury in the affected knee joint; ⑥ Those who need to perform simultaneous meniscus repair and other surgeries on the ipsilateral knee joint; ⑦ Obese BMI\>35;
Key Trial Info
Start Date :
July 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05431790
Start Date
July 30 2022
End Date
June 30 2023
Last Update
June 24 2022
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