Clinical trial NCT05431790: Absorbable Interface Screw Clinical Trial
Official title: Absorbable Interface Screw Clinical Trial - PUTH & NANTON
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Anterior cruciate ligament
absorbable interface screws
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Lysholm score
timeFrame: Asked as baseline data before surgery.
measure: Lysholm score
timeFrame: At 6 months after surgery.
measure: Lysholm score
timeFrame: At 9 months after surgery.
measure: Lysholm score
timeFrame: At 14 months after surgery.
Secondary outcomes:
measure: The upper, middle and lower diameters of the tibial bone tunnel
timeFrame: Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively.
measure: Relative tibial anterior displacement
timeFrame: Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively.
measure: Range of motion (ROM)
timeFrame: Preoperatively.
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000.
timeFrame: Asked as baseline data before surgery.
measure: Tegner score
timeFrame: Asked as baseline data before surgery.
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
timeFrame: At 6 months after surgery.
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
timeFrame: At 9 months after surgery.
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
timeFrame: At 14 months after surgery.
measure: Tegner score
timeFrame: At 6 months after surgery.
measure: Tegner score
timeFrame: At 9 months after surgery.
measure: Tegner score
timeFrame: At 14 months after surgery.
measure: Relative tibial anterior displacement
timeFrame: At 6 months postoperatively.
measure: Relative tibial anterior displacement
timeFrame: At 9 months postoperatively.
measure: Relative tibial anterior displacement
timeFrame: At 14 months postoperatively.
measure: Range of motion (ROM)
timeFrame: At 6 months postoperatively.
measure: Range of motion (ROM)
timeFrame: At 9 months postoperatively.
measure: Range of motion (ROM)
timeFrame: At 14 months postoperatively.
Other outcomes:
Locations:
Study officials:
References: