Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese

Study Overview
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Brief Summary
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The objective of this study is to compare the safety and effectiveness of Biosure Regenesorb Interference Screw versus BIOSURE HA Interference Screw (control device) in patients requiring reconstruction of cruciate ligaments of the knee. The trial results will be used for registration of Biosure Regenesorb Interference Screw in China. The primary efficacy endpoint of this study is Lysholm score at 12 months after operation. The non-inferiority testing is performed for efficiency of primary efficacy endpoint, and the test hypothesis is as follows: Invalid hypothesis: H0: μ1-μ2 ≤-δ Alternative hypothesis: H1: μ1-μ2 > -δ, where, μ1 and μ2 are the Lysholm scores in the investigational group and control group, respectively. δ is a non-inferiority critical value.

Detailed Description
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The clinical trial is designed to be a prospective, multi-center, randomized, evaluator-blinded, parallel-controlled, non-inferiority trial.

Official Title
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A Prospective, Multi-center, Randomized Clinical Study to Evaluate the Safety and Effectiveness of Biosure Regenesorb Interference Screw in Arthroscopic Reconstruction of Cruciate Ligaments in Chinese Patients

Conditions
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Cruciate Ligament Reconstruction, Knee

Intervention / Treatment
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* Device: Investigational device: Biosure Regenesorb Interference Screw
* Device: Control device: BIOSURE HA Interference Screw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the inclusion criteria: Signing the Informed Consent Form (ICF) voluntarily; Patients aged 18-75 years; Patients clinically diagnosed with knee cruciate ligaments rupture or tear and suitable for cruciate ligaments reconstruction definitely; Normal contralateral knee joint. Exclusion Criteria: Subjects with any of the following characteristics must be excluded from participation in the study: Patients not complying with the diagnosis criteria for cruciate ligaments rupture or tear; Patients with an unclosed epiphyseal plate shown on the X-ray film; Patients having underwent internal fixation or reconstruction due to a knee joint fracture; Patients with obvious knee joint degeneration shown on the X-ray film; Patients who cannot make a knee flexion of not less than 90° during operation; Patients undergoing autologous chondrocyte implantation; Patients with medial meniscus or lateral meniscus completely resected; Patients with significant anatomical abnormalities; Pregnant or breast-feeding females or those at a child-bearing age planning to become pregnant; Patients with serious osteoporosis that affects screw implantation; Patients with a malignant tumor that causes failure to effectively fix the implant; Known hypersensitivity to the implant materials; Patients not suitable for operation due to obvious local or systemic infection; Patients who cannot tolerate an operation due to severe malnutrition; Patients with severe coagulation disorder (judged by the investigator), e.g. the hemophiliac; Patients with immunodeficiency, including those who must receive immunosuppressant for a long time; Patients with extensive skin diseases; Obese patients having a Body Mass Index (BMI) > 35; Patients who cannot cooperate in postoperative rehabilitation due to a severe mental disease or those who cannot tolerate the operation due to a cardiopulmonary disease; Patients who received operation on the injured lower limb within the past 1 year; Patients who participated in any other clinical trial within the past three months; Patients who cannot follow the requirements described in the study protocol; and Other patients who are considered by the investigator not suitable for this clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Biosure Regenesorb Interference Screw<br>The Biosure Regenesorb Interference Screw, an absorbable screw designed with an open structure and made of biocomposite material, is used to fix ligaments, tendons, soft tissues or bone-tendon-bone grafts in knee surgery. | Device: Investigational device: Biosure Regenesorb Interference Screw<br>* The Biosure Regenesorb Interference Screw, an absorbable screw designed with an open structure and made of biocomposite material made of PLGA, β-TCP and calcium sulfate, is used to fix ligaments, tendons, soft tissues or bone-tendon-bone grafts in knee surgery. Its open structural design enables rapid bone ingrowth to make the screw integrated with bone tissues so as to promote healing.<br>|
| Active Comparator: The BIOSURE HA Interference Screw<br>The Biosure HA Interference Screw, an absorbable screw made of biocomposite material, is used to fix ligaments, tendons, soft tissues or bone-tendon-bone grafts in knee surgery. | Device: Control device: BIOSURE HA Interference Screw<br>* BIOSURE HA Interference Screws and Drivers are designed for durability and reduced screw breakage. Both the screws and driver have been enhanced to allow screws to fully seat on the driver all the way to the tip of the screw, helping stress distribution and force transfer. The screw design also incorporates a consistent wall thickness throughout the length of the screw for added durability and features a tapered body for ideal ease of insertion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysholm Knee Scoring Scale | The scale evaluates functions of patients based on 8 questions: limp(5 Points), support(5 Points), locking(15 Points), instability(25 Points), pain(25 Points),swelling(10 Points), stair climbing(10 Points) and squatting(5 Points). The total Lysholm Knee score is summed up all points of 8 questions. The score will range from 0 to 100 Points. Higher values represent a better outcome. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Documentation Committee (IKDC) score | The scale is composed of a knee evaluation form (10 items) and a knee ligament examination form (8 items), involving joint pain, sport level and ability of daily activities. The total score is 0-100. | Pre-Operation, Post-Operation 6 months, 12 months, 24 months | 
| Drawer test | Anterior drawer test: It is used for ACL examination. The patient will be diagnosed with forward straight instability if the tibia is forward displaced 5 mm more than the uninjured side. Posterior drawer test: It is used for PCL examination. The posterior displacement of the tibia along the femur suggests partial or complete CL rupture. | Pre-Operation, Post-Operation 6 months, 12 months, 24 months | 
| Lachman Test | The Lachman test is carried out at injured and uninjured sides simultaneously. The patient should be supine with the knees flexed to 20-30 degrees and the injured limb slightly rotated outward. The examiner stands beside the injured side, immobilizes the lower end of the femur with one hand, and presses the posterior side of the upper end of the tibia forward (Lachman test) or backward (reverse Lachman test). A positive test result is got. Positive results suggest ACL or PCL injury. | Pre-Operation, Post-Operation 6 months, 12 months, 24 months | 
| Imaging evaluation: X-ray | Take X-ray films to evaluate general view of bone. | Pre-Operation, Post-Operation 6 months, 12 months, 24 months | 
| Imaging evaluation: Computed Tomography (CT) | Computed Tomography (CT) images to evaluate specific view of bone | Pre-Operation, Post-Operation 6 months, 12 months, 24 months | 
| Imaging evaluation: Magnetic Resonance Imaging (MRI) | Magnetic Resonance Imaging (MRI) to evaluate ligament | Pre-Operation, Post-Operation 6 months, 12 months, 24 months | 
| Safety evaluation | Incidence (%) and frequency (number of events) of AEs related to device; Incidence (%) and frequency (number of events) of adverse events; Incidence (%) and frequency (number of events) of device deficiencies; Reoperation rate. | Pre-Operation, Post-Operation 6 months, 12 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomize, Biosure Regenesorb, Chinese, Cruciate ligaments reconstruction, Prospective, Evaluator-blinded