Absorbable Interface Screw Clinical Trial

Not Applicable

• Conditions: Anterior Cruciate Ligament Rupture
• Interventions: Device: Absorbable interface screws manufactured by Natong Biotechnology; Device: Absorbable interface screws manufactured by INION.

• Registration Number: NCT05431790
• Lead Sponsor: Peking University Third Hospital

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 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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-06-20
• Last Update Submitted: 2022-06-20
• Study First Posted: 2022-06-24
• Last Update Posted: 2022-06-24
• Study Start: 2022-07-30
• Primary Completion: 2023-05-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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.

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absorbable screw (Natong Biotechnology (Beijing) Co., Ltd.)	Absorbable interface screws manufactured by Natong Biotechnology	Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology.
Absorbable screw (Inion Oy, INION, Finland)	Absorbable interface screws manufactured by INION.	Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by INION.

Primary Outcome Measures

Name	Time	Method
Lysholm score	At 14 months after surgery.	An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.; Year introduced: 2015 Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.

Secondary Outcome Measures

Name	Time	Method
Tegner score	At 14 months after surgery.	Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
The upper, middle and lower diameters of the tibial bone tunnel	Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively.	The tunnel widening of the experimental group was measured compared with that of the control group.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000.	Asked as baseline data before surgery.	Currently, there are internationally recognized scales with reliability, validity and sensitivity for the assessment of anterior cruciate ligament injury and rupture. Subjective and objective symptoms of the knee joint were comprehensively assessed.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000	At 14 months after surgery.	Currently, there are internationally recognized scales with reliability, validity and sensitivity for the assessment of anterior cruciate ligament injury and rupture. Subjective and objective symptoms of the knee joint were comprehensively assessed.
Relative tibial anterior displacement	At 14 months postoperatively.	To compare whether the absorbable interface screws in the experimental group
Range of motion (ROM)	At 14 months postoperatively.	Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery