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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee; Cruciate Ligament Reconstruction
• Intervention / Treatment: Device: Investigational device: Biosure Regenesorb Interference Screw; Device: Control device: BIOSURE HA Interference Screw

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • The Third Affiliated Hospital of Southern Medical University
  • Haidian District
    • Beijing, Haidian District, China, 100191
      • Peking University Third Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • The third xiangya hospital of Central South University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital Of Xi'an Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Biosure Regenesorb Interference Screw; 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; 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.
Active Comparator: The BIOSURE HA Interference Screw; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 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).	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).	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.	Post-Operation 6 months, 12 months, 24 months
Drawer Test: Posterior	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.	Post-Operation 6 months, 12 months, 24 months
Lachman Test	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.	Post-Operation 6 months, 12 months, 24 months
Imaging Evaluation: X-ray	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.	Post-Operation 6 months, 12 months, 24 months
Imaging Evaluation: Computed Tomography (CT)	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.	Post-Operation 6 months, 12 months, 24 months
Imaging Evaluation: Magnetic Resonance Imaging (MRI)	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.	Post-Operation 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Xi Gong, Professor, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): September 11, 2021
• Study Completion (Actual): November 9, 2022

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Chinese; Prospective; Biosure Regenesorb; Cruciate ligaments reconstruction; Randomize; Evaluator-blinded
• Other Study ID Numbers: BIOSURE RG.SMD.PMA.2019.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes