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Absorbable Interface Screw Clinical Trial

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Absorbable interface screws manufactured by Natong Biotechnology
Absorbable interface screws manufactured by INION.
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring Anterior cruciate ligament, absorbable interface screws

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Absorbable screw (Natong Biotechnology (Beijing) Co., Ltd.)

    Absorbable screw (Inion Oy, INION, Finland)

    Arm Description

    Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology.

    Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by INION.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    Range of motion (ROM)
    Assessing active and passive flexion-extension angles after anterior cruciate ligament 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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    Relative tibial anterior displacement
    To compare whether the absorbable interface screws in the experimental group
    Relative tibial anterior displacement
    To compare whether the absorbable interface screws in the experimental group
    Relative tibial anterior displacement
    To compare whether the absorbable interface screws in the experimental group
    Range of motion (ROM)
    Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery
    Range of motion (ROM)
    Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery
    Range of motion (ROM)
    Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery

    Full Information

    First Posted
    May 31, 2022
    Last Updated
    June 20, 2022
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05431790
    Brief Title
    Absorbable Interface Screw Clinical Trial
    Official Title
    Absorbable Interface Screw Clinical Trial - PUTH & NANTON
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 30, 2022 (Anticipated)
    Primary Completion Date
    May 30, 2023 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Cruciate Ligament Rupture
    Keywords
    Anterior cruciate ligament, absorbable interface screws

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Participant
    Masking Description
    Blind the participant (Due to the particularity of implanted devices, blindness needs to be maintained as far as possible until the subject is automatically unblinded)
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Absorbable screw (Natong Biotechnology (Beijing) Co., Ltd.)
    Arm Type
    Experimental
    Arm Description
    Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology.
    Arm Title
    Absorbable screw (Inion Oy, INION, Finland)
    Arm Type
    Active Comparator
    Arm Description
    Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by INION.
    Intervention Type
    Device
    Intervention Name(s)
    Absorbable interface screws manufactured by Natong Biotechnology
    Intervention Description
    Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology.
    Intervention Type
    Device
    Intervention Name(s)
    Absorbable interface screws manufactured by INION.
    Intervention Description
    Reconstruction of anterior cruciate ligament using Inion Oy absorbable interface scews from INION, Finland
    Primary Outcome Measure Information:
    Title
    Lysholm score
    Description
    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.
    Time Frame
    Asked as baseline data before surgery.
    Title
    Lysholm score
    Description
    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.
    Time Frame
    At 6 months after surgery.
    Title
    Lysholm score
    Description
    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.
    Time Frame
    At 9 months after surgery.
    Title
    Lysholm score
    Description
    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.
    Time Frame
    At 14 months after surgery.
    Secondary Outcome Measure Information:
    Title
    The upper, middle and lower diameters of the tibial bone tunnel
    Description
    The tunnel widening of the experimental group was measured compared with that of the control group.
    Time Frame
    Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively.
    Title
    Relative tibial anterior displacement
    Description
    To compare whether the absorbable interface screws in the experimental group can effectively limit the anterior displacement of the tibia relative to the femur.
    Time Frame
    Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively.
    Title
    Range of motion (ROM)
    Description
    Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery
    Time Frame
    Preoperatively.
    Title
    International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000.
    Description
    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.
    Time Frame
    Asked as baseline data before surgery.
    Title
    Tegner score
    Description
    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.
    Time Frame
    Asked as baseline data before surgery.
    Title
    International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
    Description
    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.
    Time Frame
    At 6 months after surgery.
    Title
    International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
    Description
    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.
    Time Frame
    At 9 months after surgery.
    Title
    International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
    Description
    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.
    Time Frame
    At 14 months after surgery.
    Title
    Tegner score
    Description
    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.
    Time Frame
    At 6 months after surgery.
    Title
    Tegner score
    Description
    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.
    Time Frame
    At 9 months after surgery.
    Title
    Tegner score
    Description
    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.
    Time Frame
    At 14 months after surgery.
    Title
    Relative tibial anterior displacement
    Description
    To compare whether the absorbable interface screws in the experimental group
    Time Frame
    At 6 months postoperatively.
    Title
    Relative tibial anterior displacement
    Description
    To compare whether the absorbable interface screws in the experimental group
    Time Frame
    At 9 months postoperatively.
    Title
    Relative tibial anterior displacement
    Description
    To compare whether the absorbable interface screws in the experimental group
    Time Frame
    At 14 months postoperatively.
    Title
    Range of motion (ROM)
    Description
    Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery
    Time Frame
    At 6 months postoperatively.
    Title
    Range of motion (ROM)
    Description
    Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery
    Time Frame
    At 9 months postoperatively.
    Title
    Range of motion (ROM)
    Description
    Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery
    Time Frame
    At 14 months postoperatively.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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;

    12. IPD Sharing Statement

    Learn more about this trial

    Absorbable Interface Screw Clinical Trial

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