N/A
N=139
Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese
Cruciate Ligament Reconstruction · Knee
Bottom Line
View on ClinicalTrials.gov: NCT04012567 ↗Enrolled (actual)
139
Serious AEs
4.3%
Results posted
Mar 2025
Primary outcome: Primary: Lysholm Knee Scoring Scale 12 Months After Operation — 92.49; 94.14 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational device: Biosure Regenesorb Interference Screw (Device); Control device: BIOSURE HA Interference Screw (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lysholm Knee Scoring Scale 12 Months After Operation |
92.49; 94.14 | — |
| SECONDARY Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation |
72.42; 70.19; 87.35; 87.14; 94.22; 94.96 | — |
| SECONDARY International Knee Documentation Committee (IKDC) Score |
66.75; 65.50; 80.98; 80.01; 88.83; 91.00 | — |
| SECONDARY Drawer Test: Anterior |
68; 67; 0; 0; 61; 67 | — |
| SECONDARY Drawer Test: Posterior |
68; 66; 0; 1; 61; 67 | — |
| SECONDARY Lachman Test |
68; 67; 0; 0; 61; 67 | — |
| SECONDARY Imaging Evaluation: X-ray |
0; 1; 67; 65; 1; 1 | — |
| SECONDARY Imaging Evaluation: Computed Tomography (CT) |
0; 0; 67; 66; 0; 0 | — |
| SECONDARY Imaging Evaluation: Magnetic Resonance Imaging (MRI) |
0; 0; 68; 67; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04012567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.