Absorbable Interface Screw Clinical Trial

Peking University

Status

Unknown

Conditions

Anterior Cruciate Ligament Rupture

Treatments

Device: Absorbable interface screws manufactured by INION.

Device: Absorbable interface screws manufactured by Natong Biotechnology

Study type

Interventional

Funder types

Other

Identifiers

NCT05431790

IRB00006761-D2022055

Details and patient eligibility

About

Validation of the safety and efficacy of absorbable interface screws for clinical use

Full 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 screws are mainly polylactic acid and polyglycolide. The test product is composed of two kinds of polylactic acid and bioactive glass fiber, which can reduce the adverse stimulation to the surrounding bone, promote the absorption of the screw and the bone grow into.Estimated enrollment for 4 months, follow-up for 14 months, a total of 18 months.

Enrollment

86 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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;