Anterior Cruciate Ligament Rupture
Conditions
Keywords
Anterior cruciate ligament, absorbable interface screws
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.
Interventions
DEVICEAbsorbable interface screws manufactured by Natong Biotechnology
Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology.
DEVICEAbsorbable interface screws manufactured by INION.
Reconstruction of anterior cruciate ligament using Inion Oy absorbable interface scews from INION, Finland
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lysholm score | Asked as baseline data before surgery. | 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
| Measure | Time frame | Description |
|---|---|---|
| Relative tibial anterior displacement | Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively. | 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) | Preoperatively. | Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery |
| The upper, middle and lower diameters of the tibial bone tunnel | Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively. | The tunnel widening of the experimental group was measured compared with that of the control group. |
| Tegner score | Asked as baseline data before surgery. | 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 | At 6 months after surgery. | 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. | Asked as baseline data before surgery. | 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. |
Outcome results
None listed