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出境医 / 临床实验 / Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese (BIOSURE RG)

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

Study Description
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.


Condition or disease Intervention/treatment Phase
Cruciate Ligament Reconstruction Knee Device: Investigational device: Biosure Regenesorb Interference Screw Device: Control device: BIOSURE HA Interference Screw Not Applicable

Detailed Description:
The clinical trial is designed to be a prospective, multi-center, randomized, evaluator-blinded, parallel-controlled, non-inferiority trial.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 17, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2023
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. Lysholm Knee Scoring Scale [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. International Knee Documentation Committee (IKDC) score [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    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.

  2. Drawer test [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    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.

  3. Lachman Test [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    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.

  4. Imaging evaluation: X-ray [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    Take X-ray films to evaluate general view of bone.

  5. Imaging evaluation: Computed Tomography (CT) [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    Computed Tomography (CT) images to evaluate specific view of bone

  6. Imaging evaluation: Magnetic Resonance Imaging (MRI) [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    Magnetic Resonance Imaging (MRI) to evaluate ligament

  7. Safety evaluation [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    1. Incidence (%) and frequency (number of events) of AEs related to device;
    2. Incidence (%) and frequency (number of events) of adverse events;
    3. Incidence (%) and frequency (number of events) of device deficiencies;
    4. Reoperation rate.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Brook Li +86 010-64198395 Brook.Li@smith-nephew.com
Contact: Astrid Yung +86 010-64198200 Astrid.Yung@smith-nephew.com

Locations
Layout table for location information
China, Guangdong
The Third Affiliated Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Chun Zeng    +86 13710760058    zengdavid@126.com   
Principal Investigator: Chun Zeng         
China, Haidian District
Peking University Third Hospital Recruiting
Beijing, Haidian District, China, 100191
Contact: Xi Gong    +86 010-82267068    gongxi518@163.com   
Principal Investigator: Xi Gong         
China, Hunan
The Third Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410000
Contact: Song Wu    +86 13787318155    Swhn9058@163.com   
Principal Investigator: Song Wu         
China, Shaanxi
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Zhanhai Yin    +86 18991232489    yin@mail.xjtu.edu.cn   
Principal Investigator: Zhanhai Yin         
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Xi Gong, Professor Peking University Third Hospital
Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date May 1, 2020
Actual Study Start Date  ICMJE December 17, 2019
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		Lysholm Knee Scoring Scale [ Time Frame: 12 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
  • International Knee Documentation Committee (IKDC) score [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    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.
  • Drawer test [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    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.
  • Lachman Test [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    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.
  • Imaging evaluation: X-ray [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    Take X-ray films to evaluate general view of bone.
  • Imaging evaluation: Computed Tomography (CT) [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    Computed Tomography (CT) images to evaluate specific view of bone
  • Imaging evaluation: Magnetic Resonance Imaging (MRI) [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    Magnetic Resonance Imaging (MRI) to evaluate ligament
  • Safety evaluation [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months ]
    1. Incidence (%) and frequency (number of events) of AEs related to device;
    2. Incidence (%) and frequency (number of events) of adverse events;
    3. Incidence (%) and frequency (number of events) of device deficiencies;
    4. Reoperation rate.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • IKDC score [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months. ]
    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.
  • Drawer test [ Time Frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months. ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cruciate Ligament Reconstruction
  • Knee
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Investigational device: Biosure Regenesorb Interference Screw
  • 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.
    Intervention: Device: Control device: BIOSURE HA Interference Screw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019) 		140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brook Li +86 010-64198395 Brook.Li@smith-nephew.com
Contact: Astrid Yung +86 010-64198200 Astrid.Yung@smith-nephew.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012567
Other Study ID Numbers  ICMJE BIOSURE RG.SMD.PMA.2019.01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Smith & Nephew, Inc.
Study Sponsor  ICMJE Smith & Nephew, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xi Gong, Professor Peking University Third Hospital
PRS Account Smith & Nephew, Inc.
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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