Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese
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
1 other identifier
interventional
140
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedStudy Start
First participant enrolled
December 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2022
CompletedResults Posted
Study results publicly available
March 25, 2025
CompletedMarch 25, 2025
August 1, 2024
1.7 years
June 12, 2019
March 4, 2025
March 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation
Pre-Operation, Post-Operation 6 months, 24 months
International Knee Documentation Committee (IKDC) Score
Pre-Operation, Post-Operation 6 months, 12 months, 24 months
Drawer Test: Anterior
Post-Operation 6 months, 12 months, 24 months
Drawer Test: Posterior
Post-Operation 6 months, 12 months, 24 months
Lachman Test
Post-Operation 6 months, 12 months, 24 months
- +3 more secondary outcomes
Study Arms (2)
The Biosure Regenesorb Interference Screw
EXPERIMENTALThe 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.
The BIOSURE HA Interference Screw
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Signing the Informed Consent Form (ICF) voluntarily;
- Patients aged 18-75 years;
- Patients clinically diagnosed with knee cruciate ligaments rupture or tear and suitable for cruciate ligaments reconstruction definitely;
- Normal contralateral knee joint.
You may not qualify if:
- Subjects with any of the following characteristics must be excluded from participation in the study:
- Patients not complying with the diagnosis criteria for cruciate ligaments rupture or tear;
- Patients with an unclosed epiphyseal plate shown on the X-ray film;
- Patients having underwent internal fixation or reconstruction due to a knee joint fracture;
- Patients with obvious knee joint degeneration shown on the X-ray film;
- Patients who cannot make a knee flexion of not less than 90° during operation;
- Patients undergoing autologous chondrocyte implantation;
- Patients with medial meniscus or lateral meniscus completely resected;
- Patients with significant anatomical abnormalities;
- Pregnant or breast-feeding females or those at a child-bearing age planning to become pregnant;
- Patients with serious osteoporosis that affects screw implantation;
- Patients with a malignant tumor that causes failure to effectively fix the implant;
- Known hypersensitivity to the implant materials;
- Patients not suitable for operation due to obvious local or systemic infection;
- Patients who cannot tolerate an operation due to severe malnutrition;
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 510000, China
Peking University Third Hospital
Beijing, Haidian District, 100191, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Results Point of Contact
- Title
- Senior Manager Clinical Compliance
- Organization
- Smith+Nephew, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Xi Gong, Professor
Peking University Third Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2019
First Posted
July 9, 2019
Study Start
December 17, 2019
Primary Completion
September 11, 2021
Study Completion
November 9, 2022
Last Updated
March 25, 2025
Results First Posted
March 25, 2025
Record last verified: 2024-08