Status:
COMPLETED
Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Cruciate Ligament Reconstruction
Knee
Eligibility:
All Genders
18-75 years
Phase:
NA
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 reconstructi...
Detailed Description
The clinical trial is designed to be a prospective, multi-center, randomized, evaluator-blinded, parallel-controlled, non-inferiority trial.
Eligibility Criteria
Inclusion
- Subjects must meet all of the inclusion criteria:
- 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.
Exclusion
- 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;
- Patients with severe coagulation disorder (judged by the investigator), e.g. the hemophiliac;
- Patients with immunodeficiency, including those who must receive immunosuppressant for a long time;
- Patients with extensive skin diseases;
- Obese patients having a Body Mass Index (BMI) \> 35;
- 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;
- Patients who received operation on the injured lower limb within the past 1 year;
- Patients who participated in any other clinical trial within the past three months;
- Patients who cannot follow the requirements described in the study protocol; and
- Other patients who are considered by the investigator not suitable for this clinical study.
Key Trial Info
Start Date :
December 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2022
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04012567
Start Date
December 17 2019
End Date
November 9 2022
Last Update
March 25 2025
Active Locations (4)
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1
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000
2
Peking University Third Hospital
Beijing, Haidian District, China, 100191
3
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
4
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061