Absorbable Interface Screw Clinical Trial

Study Overview
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Brief Summary
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Validation of the safety and efficacy of absorbable interface screws for clinical use

Detailed Description
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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.

Official Title
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Absorbable Interface Screw Clinical Trial - PUTH & NANTON

Conditions
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Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Device: Absorbable interface screws manufactured by Natong Biotechnology
* Device: Absorbable interface screws manufactured by INION.


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random assignment of patients with anterior cruciate ligament reconstruction (The test group uses the test product; the control group uses the marketed product)Blind the subjects.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Absorbable screw (Natong Biotechnology (Beijing) Co., Ltd.)<br>Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology. | Device: Absorbable interface screws manufactured by Natong Biotechnology<br>* Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology.<br>|
| Active Comparator: Absorbable screw (Inion Oy, INION, Finland)<br>Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by INION. | Device: Absorbable interface screws manufactured by INION.<br>* Reconstruction of anterior cruciate ligament using Inion Oy absorbable interface scews from INION, Finland<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysholm score | 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. | Asked as baseline data before surgery. | 
| Lysholm score | 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. | At 6 months after surgery. | 
| Lysholm score | 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. | At 9 months after surgery. | 
| Lysholm score | 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. | At 14 months after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The upper, middle and lower diameters of the tibial bone tunnel | The tunnel widening of the experimental group was measured compared with that of the control group. | Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively. | 
| Relative tibial anterior displacement | To compare whether the absorbable interface screws in the experimental group can effectively limit the anterior displacement of the tibia relative to the femur. | Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively. | 
| Range of motion (ROM) | Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery | Preoperatively. | 
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000. | 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. | Asked as baseline data before surgery. | 
| Tegner score | 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. | Asked as baseline data before surgery. | 
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000 | 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. | At 6 months after surgery. | 
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000 | 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. | At 9 months after surgery. | 
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000 | 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. | At 14 months after surgery. | 
| Tegner score | 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. | At 6 months after surgery. | 
| Tegner score | 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. | At 9 months after surgery. | 
| Tegner score | 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. | At 14 months after surgery. | 
| Relative tibial anterior displacement | To compare whether the absorbable interface screws in the experimental group | At 6 months postoperatively. | 
| Relative tibial anterior displacement | To compare whether the absorbable interface screws in the experimental group | At 9 months postoperatively. | 
| Relative tibial anterior displacement | To compare whether the absorbable interface screws in the experimental group | At 14 months postoperatively. | 
| Range of motion (ROM) | Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery | At 6 months postoperatively. | 
| Range of motion (ROM) | Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery | At 9 months postoperatively. | 
| Range of motion (ROM) | Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery | At 14 months postoperatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior cruciate ligament, absorbable interface screws