Absorbable Interface Screw Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-30

Study Completion Date

2023-06-30

Brief Summary

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

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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.

Conditions

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Anterior Cruciate Ligament Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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)

Study Groups

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

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

Group Type EXPERIMENTAL

Absorbable interface screws manufactured by Natong Biotechnology

Intervention Type DEVICE

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

Absorbable screw (Inion Oy, INION, Finland)

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

Group Type ACTIVE_COMPARATOR

Absorbable interface screws manufactured by INION.

Intervention Type DEVICE

Reconstruction of anterior cruciate ligament using Inion Oy absorbable interface scews from INION, Finland

Interventions

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Absorbable interface screws manufactured by Natong Biotechnology

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

Intervention Type DEVICE

Absorbable interface screws manufactured by INION.

Reconstruction of anterior cruciate ligament using Inion Oy absorbable interface scews from INION, Finland

Intervention Type DEVICE

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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No