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

NCT ID: NCT04012567

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-17
• Study Completion Date: 2022-11-09

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.

Conditions

Cruciate Ligament Reconstruction; Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Investigational device: Biosure Regenesorb Interference Screw

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Control device: BIOSURE HA Interference Screw

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xi Gong, Professor

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Peking University Third Hospital

Beijing, Haidian District, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BIOSURE RG.SMD.PMA.2019.01

Identifier Type: -

Identifier Source: org_study_id