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

Smith & Nephew, Inc.140 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Cruciate Ligament Reconstruction Knee

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must meet all of the inclusion criteria: 1. Signing the Informed Consent Form (ICF) voluntarily; 2. Patients aged 18-75 years; 3. Patients clinically diagnosed with knee cruciate ligaments rupture or tear and suitable for cruciate ligaments reconstruction definitely; 4. Normal contralateral knee joint. Exclusion Criteria: * Subjects with any of the following characteristics must be excluded from participation in the study: 1. Patients not complying with the diagnosis criteria for cruciate ligaments rupture or tear; 2. Patients with an unclosed epiphyseal plate shown on the X-ray film; 3. Patients having underwent internal fixation or reconstruction due to a knee joint fracture; 4. Patients with obvious knee joint degeneration shown on the X-ray film; 5. Patients who cannot make a knee flexion of not less than 90° during operation; 6. Patients undergoing autologous chondrocyte implantation; 7. Patients with medial meniscus or lateral meniscus completely resected; 8. Patients with significant anatomical abnormalities; 9. Pregnant or breast-feeding females or those at a child-bearing age planning to become pregnant; 10. Patients with serious osteoporosis that affects screw implantation; 11. Patients with a malignant tumor that causes failure to effectively fix the implant; 12. Known hypersensitivity to the implant materials; 13. Patients not suitable for operation due to obvious local or systemic infection; 14. Patients who cannot tolerate an operation due to severe malnutrition; 15. Patients with severe coagulation disorder (judged by the investigator), e.g. the hemophiliac; 16. Patients with immunodeficiency, including those who must receive immunosuppressant for a long time; 17. Patients with extensive skin diseases; 18. Obese patients having a Body Mass Index (BMI) \> 35; 19. 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; 20. Patients who received operation on the injured lower limb within the past 1 year; 21. Patients who participated in any other clinical trial within the past three months; 22. Patients who cannot follow the requirements described in the study protocol; and 23. Other patients who are considered by the investigator not suitable for this clinical study.

Outcomes

Primary Outcomes

Lysholm Knee Scoring Scale 12 Months After Operation

Lysholm Knee Scoring Scale evaluates functions of participants based on 8 items: limp, support, interlocking, pain, instability, swelling, stair climbing and squatting. The total Lysholm score is 0-100. Pain and instability account for a higher proportion in this score. The knee functions of patients are considered excellent when the score is 95-100, good when 84-94, fair when 65-83 and poor when less than 65 (i.e., 100 is best outcome and 0 is the worst outcome).

Time frame: 12 months

Secondary Outcomes

Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation

Time frame: Pre-Operation, Post-Operation 6 months, 24 months

International Knee Documentation Committee (IKDC) Score

The International Knee Documentation Committee (IKDC) score 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 transformed to a scale ranging from 0 to 100, where 0 represents the lowest level of knee function and highest level of symptoms (i.e., worst outcome), and 100 represents the highest level of knee function and lowest level of symptoms (i.e., best outcome).

Time frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months

Drawer Test: Anterior

The Anterior Drawer Test is used for anterior cruciate ligament (ACL) examination with an outcome of either negative or positive. The test was performed with the participant lying supine with the knee flexed at 90 degrees and the foot stabilized flat on the table. The examiner then grasped the tibia and applied an anterior force to assess displacement. The test outcome was measured by the number of participants with a negative or positive result. A positive test indicated forward straight instability, defined as the tibia being displaced forward by 5 millimeters (mm) or more compared to the uninjured side.