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

Not Applicable

Completed

Conditions: Cruciate Ligament Reconstruction
Knee

Registration Number: NCT04012567

Lead Sponsor: Smith & Nephew, Inc.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 140

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lysholm Knee Scoring Scale 12 Months After Operation	12 months	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).

Secondary Outcome Measures

Name	Time	Method
Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation	Pre-Operation, Post-Operation 6 months, 24 months	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).
International Knee Documentation Committee (IKDC) Score	Pre-Operation, Post-Operation 6 months, 12 months, 24 months	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).
Drawer Test: Anterior	Post-Operation 6 months, 12 months, 24 months	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.
Drawer Test: Posterior	Post-Operation 6 months, 12 months, 24 months	The Posterior Drawer Test is used for posterior cruciate ligament (PCL) 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. The examiner placed both hands on the proximal lower leg (just below the knee joint) with thumbs on the tibial tuberosity then attempted to translate the lower leg posteriorly. The test outcome was measured by the number of participants with a negative or positive result. A positive test indicated a lack of end feel or excessive posterior translation.
Lachman Test	Post-Operation 6 months, 12 months, 24 months	The Lachman Test assessed integrity of the anterior cruciate ligament (ACL) with an outcome of either negative or positive. The test was performed with the participant lying supine with the knee flexed to 20-30 degrees and the injured limb slightly rotated outward. The examiner immobilized the lower end of the femur with one hand and pressed the posterior side of the upper end of the tibia forward or backward. The test outcome was measured by the number of participants with a negative or positive result. A positive test indicated excessive anterior translation of the tibia greater than the uninjured side along with a soft end feel.
Imaging Evaluation: X-ray	Post-Operation 6 months, 12 months, 24 months	Radiographic assessment taken from x-ray images to evaluate the general view of bone. The assessment measured the number of participants categorized with either a normal or abnormal imaging evaluation.
Imaging Evaluation: Computed Tomography (CT)	Post-Operation 6 months, 12 months, 24 months	Radiographic assessment taken from Computed Tomography (CT) images to evaluate specific view of bone. The assessment measured the number of participants categorized with either a normal or abnormal imaging evaluation.
Imaging Evaluation: Magnetic Resonance Imaging (MRI)	Post-Operation 6 months, 12 months, 24 months	Radiographic assessment taken from Magnetic Resonance Imaging (MRI) to evaluate ligament. The assessment measured the number of participants categorized with either a normal or abnormal imaging evaluation.

Trial Locations

Locations (4): The Third Affiliated Hospital of Southern Medical University
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Guangzhou, Guangdong, China
Peking University Third Hospital
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Beijing, Haidian District, China
The Third Xiangya Hospital of Central South University
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Changsha, Hunan, China
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi'an, Shaanxi, China