Cruciate Ligament ReconstructionNCT04012567
Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese
A study testing Investigational device: Biosure Regenesorb Interference Screw in people with Cruciate Ligament Reconstruction and Knee, run by Smith & Nephew, Inc. at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cruciate Ligament Reconstruction, Knee
- What is being tested?
- Investigational device: Biosure Regenesorb Interference Screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesChina
- Study dates
- 17 Dec 2019to 9 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking University Third Hospital
Beijing, Haidian District, 100191
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
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
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.
Read the 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
- Being tested
- Investigational device: Biosure Regenesorb Interference Screw, Control device: BIOSURE HA Interference Screw
- Keywords
- Biosure Regenesorb, Chinese, Cruciate ligaments reconstruction, Prospective, Randomize, Evaluator-blinded
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational device: Biosure Regenesorb Interference ScrewDevice
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.
Control device: BIOSURE HA Interference ScrewDevice
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 group | Role | What they receive |
|---|---|---|
| The Biosure Regenesorb Interference Screw | Experimental | 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. Receives: Device: Investigational device: Biosure Regenesorb Interference Screw |
| The BIOSURE HA Interference Screw | Active comparator | 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. Receives: Device: Control device: BIOSURE HA Interference Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (8)
Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 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).
Measured: Pre-Operation, Post-Operation 6 months, 24 months
International Knee Documentation Committee (IKDC) Score
The International Knee Documentation Committee (IKDC) score 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 transformed to a scale ranging from 0 to 100, where 0 represents the lowest level of knee function and highest level of symptoms (i.e., worst outcome), and 100 represents the highest level of knee function and lowest level of symptoms (i.e., best outcome).
Measured: Pre-Operation, Post-Operation 6 months, 12 months, 24 months
Drawer Test: Anterior
The Anterior Drawer Test is used for anterior cruciate ligament (ACL) examination with an outcome of either negative or positive. The test was performed with the participant lying supine with the knee flexed at 90 degrees and the foot stabilized flat on the table. The examiner then grasped the tibia and applied an anterior force to assess displacement. The test outcome was measured by the number of participants with a negative or positive result. A positive test indicated forward straight instability, defined as the tibia being displaced forward by 5 millimeters (mm) or more compared to the uninjured side.
Measured: Post-Operation 6 months, 12 months, 24 months
Drawer Test: Posterior
The Posterior Drawer Test is used for posterior cruciate ligament (PCL) examination with an outcome of either negative or positive. The test was performed with the participant lying supine with the knee flexed at 90 degrees. The examiner placed both hands on the proximal lower leg (just below the knee joint) with thumbs on the tibial tuberosity then attempted to translate the lower leg posteriorly. The test outcome was measured by the number of participants with a negative or positive result. A positive test indicated a lack of end feel or excessive posterior translation.
Measured: Post-Operation 6 months, 12 months, 24 months
Lachman Test
The Lachman Test assessed integrity of the anterior cruciate ligament (ACL) with an outcome of either negative or positive. The test was performed with the participant lying supine with the knee flexed to 20-30 degrees and the injured limb slightly rotated outward. The examiner immobilized the lower end of the femur with one hand and pressed the posterior side of the upper end of the tibia forward or backward. The test outcome was measured by the number of participants with a negative or positive result. A positive test indicated excessive anterior translation of the tibia greater than the uninjured side along with a soft end feel.
Measured: Post-Operation 6 months, 12 months, 24 months
Imaging Evaluation: X-ray
Radiographic assessment taken from x-ray images to evaluate the general view of bone. The assessment measured the number of participants categorized with either a normal or abnormal imaging evaluation.
Measured: Post-Operation 6 months, 12 months, 24 months
Imaging Evaluation: Computed Tomography (CT)
Radiographic assessment taken from Computed Tomography (CT) images to evaluate specific view of bone. The assessment measured the number of participants categorized with either a normal or abnormal imaging evaluation.
Measured: Post-Operation 6 months, 12 months, 24 months
Imaging Evaluation: Magnetic Resonance Imaging (MRI)
Radiographic assessment taken from Magnetic Resonance Imaging (MRI) to evaluate ligament. The assessment measured the number of participants categorized with either a normal or abnormal imaging evaluation.
Measured: Post-Operation 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start17 Dec 2019
- Primary completion11 Sep 2021
- Study completion9 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xi Gong, Professor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012567
- Sponsor's protocol ID
- BIOSURE RG.SMD.PMA.2019.01
- Status last verified
- Aug 2024
- First submitted
- 12 Jun 2019
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04012567
- Acronym / sponsor ID
- BIOSURE RG.SMD.PMA.2019.01
- Conditions
- Cruciate Ligament Reconstruction, Knee
- Keywords
- Biosure Regenesorb, Chinese, Cruciate ligaments reconstruction, Prospective, Randomize, Evaluator-blinded
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 11 Sep 2021 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Biosure Regenesorb Interference Screw | Experimental | Device: Investigational device: Biosure Regenesorb Interference ScrewThe 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 comparator | Device: Control device: BIOSURE HA Interference ScrewThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must meet all of the inclusion criteria:
Key exclusion criteria (24 listed)
- Subjects with any of the following characteristics must be excluded from participation in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational device: Biosure Regenesorb Interference ScrewThe 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 | The Biosure Regenesorb Interference Screw |
| Control device: BIOSURE HA Interference ScrewBIOSURE 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. | Device | The BIOSURE HA Interference Screw |
Primary outcome
Lysholm Knee Scoring Scale 12 Months After Operation
Time frame: 12 months
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).
8 secondary outcomes
Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation
Time frame: Pre-Operation, Post-Operation 6 months, 24 months
International Knee Documentation Committee (IKDC) Score
Time frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months
Drawer Test: Anterior
Time frame: Post-Operation 6 months, 12 months, 24 months
Drawer Test: Posterior
Time frame: Post-Operation 6 months, 12 months, 24 months
Lachman Test
Time frame: Post-Operation 6 months, 12 months, 24 months
Imaging Evaluation: X-ray
Time frame: Post-Operation 6 months, 12 months, 24 months
Imaging Evaluation: Computed Tomography (CT)
Time frame: Post-Operation 6 months, 12 months, 24 months
Imaging Evaluation: Magnetic Resonance Imaging (MRI)
Time frame: Post-Operation 6 months, 12 months, 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xi Gong, Professor principal investigator
Peking University Third Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational device: Biosure Regenesorb Interference Screw in people with Cruciate Ligament Reconstruction and Knee, run by Smith & Nephew, Inc. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm Knee Scoring Scale 12 Months After Operation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.