Absorbable Interface Screw Clinical Trial

Absorbable Interface Screw Clinical Trial - PUTH & NANTON

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

Study Overview

• Status: Not yet recruiting
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Device: Absorbable interface screws manufactured by Natong Biotechnology; Device: Absorbable interface screws manufactured by INION.

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 Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 30, 2022
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Anterior cruciate ligament; absorbable interface screws
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: IRB00006761-D2022055

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No