Validation of the safety and efficacy of absorbable interface screws for clinical use
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
86
Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology.
Reconstruction of anterior cruciate ligament using Inion Oy absorbable interface scews from INION, Finland
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 14 months after surgery.
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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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 14 months after surgery.
Relative tibial anterior displacement
To compare whether the absorbable interface screws in the experimental group
Time frame: At 6 months postoperatively.
Relative tibial anterior displacement
To compare whether the absorbable interface screws in the experimental group
Time frame: At 9 months postoperatively.
Relative tibial anterior displacement
To compare whether the absorbable interface screws in the experimental group
Time frame: At 14 months postoperatively.
Range of motion (ROM)
Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery
Time frame: At 6 months postoperatively.
Range of motion (ROM)
Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery
Time frame: At 9 months postoperatively.
Range of motion (ROM)
Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery
Time frame: At 14 months postoperatively.