Cruciate Ligament Reconstruction, Knee
Conditions
Keywords
Biosure Regenesorb, Chinese, Cruciate ligaments reconstruction, Prospective, Randomize, Evaluator-blinded
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.
Interventions
DEVICEInvestigational 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.
DEVICEControl 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.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lysholm Knee Scoring Scale 12 Months After Operation | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee (IKDC) Score | Pre-Operation, Post-Operation 6 months, 12 months, 24 months | 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). |
| Drawer Test: Anterior | Post-Operation 6 months, 12 months, 24 months | 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. |
| Drawer Test: Posterior | Post-Operation 6 months, 12 months, 24 months | 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. |
| Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation | Pre-Operation, Post-Operation 6 months, 24 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). |
| Imaging Evaluation: X-ray | Post-Operation 6 months, 12 months, 24 months | 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. |
| Imaging Evaluation: Computed Tomography (CT) | Post-Operation 6 months, 12 months, 24 months | 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. |
| Imaging Evaluation: Magnetic Resonance Imaging (MRI) | Post-Operation 6 months, 12 months, 24 months | 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. |
| Lachman Test | Post-Operation 6 months, 12 months, 24 months | 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. |
Countries
China
Participant flow
Pre-assignment details
One participant enrolled in the study was excluded because their cruciate ligament was found to be unbroken during operation.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 69 |
| 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.
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. | 70 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | The Biosure Regenesorb Interference Screw | The BIOSURE HA Interference Screw | Total |
|---|---|---|---|
| Age, Continuous | 30.12 years STANDARD_DEVIATION 8.9 | 33.69 years STANDARD_DEVIATION 9.89 | 31.91 years STANDARD_DEVIATION 9.54 |
| Body Mass Index (BMI) | 24.31 kg/m^2 STANDARD_DEVIATION 3.29 | 24.78 kg/m^2 STANDARD_DEVIATION 3.14 | 24.55 kg/m^2 STANDARD_DEVIATION 3.21 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 54 Participants | 57 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 70 |
| other Total, other adverse events | 30 / 69 | 26 / 70 |
| serious Total, serious adverse events | 3 / 69 | 3 / 70 |
Outcome results
Primary
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).
Time frame: 12 months
Population: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Biosure Regenesorb Interference Screw | Lysholm Knee Scoring Scale 12 Months After Operation | 92.49 score on a scale | Standard Deviation 10.61 |
| The BIOSURE HA Interference Screw | Lysholm Knee Scoring Scale 12 Months After Operation | 94.14 score on a scale | Standard Deviation 7.13 |
Secondary
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.
Time frame: Post-Operation 6 months, 12 months, 24 months
Population: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| The Biosure Regenesorb Interference Screw | Drawer Test: Anterior | Post-Operation 6 months | Negative | 68 Participants |
| The Biosure Regenesorb Interference Screw | Drawer Test: Anterior | Post-Operation 6 months | Postive | 0 Participants |
| The Biosure Regenesorb Interference Screw | Drawer Test: Anterior | 12 months | Negative | 61 Participants |
| The Biosure Regenesorb Interference Screw | Drawer Test: Anterior | 12 months | Postive | 0 Participants |
| The Biosure Regenesorb Interference Screw | Drawer Test: Anterior | 24 months | Negative | 53 Participants |
| The Biosure Regenesorb Interference Screw | Drawer Test: Anterior | 24 months | Postive | 0 Participants |
| The BIOSURE HA Interference Screw | Drawer Test: Anterior | 24 months | Negative | 61 Participants |
| The BIOSURE HA Interference Screw | Drawer Test: Anterior | Post-Operation 6 months | Negative | 67 Participants |
| The BIOSURE HA Interference Screw | Drawer Test: Anterior | 12 months | Postive | 0 Participants |
| The BIOSURE HA Interference Screw | Drawer Test: Anterior | Post-Operation 6 months | Postive | 0 Participants |
| The BIOSURE HA Interference Screw | Drawer Test: Anterior | 24 months | Postive | 0 Participants |
| The BIOSURE HA Interference Screw | Drawer Test: Anterior | 12 months | Negative | 67 Participants |
Secondary
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.
Time frame: Post-Operation 6 months, 12 months, 24 months
Population: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| The Biosure Regenesorb Interference Screw | Drawer Test: Posterior | Post-Operation 6 months | Negative | 68 Participants |
| The Biosure Regenesorb Interference Screw | Drawer Test: Posterior | Post-Operation 6 months | Positive | 0 Participants |
| The Biosure Regenesorb Interference Screw | Drawer Test: Posterior | 12 months | Negative | 61 Participants |
| The Biosure Regenesorb Interference Screw | Drawer Test: Posterior | 12 months | Positive | 0 Participants |
| The Biosure Regenesorb Interference Screw | Drawer Test: Posterior | 24 months | Negative | 49 Participants |
| The Biosure Regenesorb Interference Screw | Drawer Test: Posterior | 24 months | Positive | 0 Participants |
| The BIOSURE HA Interference Screw | Drawer Test: Posterior | 24 months | Negative | 57 Participants |
| The BIOSURE HA Interference Screw | Drawer Test: Posterior | Post-Operation 6 months | Negative | 66 Participants |
| The BIOSURE HA Interference Screw | Drawer Test: Posterior | 12 months | Positive | 0 Participants |
| The BIOSURE HA Interference Screw | Drawer Test: Posterior | Post-Operation 6 months | Positive | 1 Participants |
| The BIOSURE HA Interference Screw | Drawer Test: Posterior | 24 months | Positive | 0 Participants |
| The BIOSURE HA Interference Screw | Drawer Test: Posterior | 12 months | Negative | 67 Participants |
Secondary
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.
Time frame: Post-Operation 6 months, 12 months, 24 months
Population: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: Computed Tomography (CT) | Post-op 6 months | Normal | 0 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: Computed Tomography (CT) | Post-op 6 months | Abnormal | 67 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: Computed Tomography (CT) | 12 months | Normal | 0 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: Computed Tomography (CT) | 12 months | Abnormal | 61 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: Computed Tomography (CT) | 24 months | Normal | 0 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: Computed Tomography (CT) | 24 months | Abnormal | 50 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: Computed Tomography (CT) | 24 months | Normal | 0 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: Computed Tomography (CT) | Post-op 6 months | Normal | 0 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: Computed Tomography (CT) | 12 months | Abnormal | 66 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: Computed Tomography (CT) | Post-op 6 months | Abnormal | 66 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: Computed Tomography (CT) | 24 months | Abnormal | 61 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: Computed Tomography (CT) | 12 months | Normal | 0 Participants |
Secondary
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.
Time frame: Post-Operation 6 months, 12 months, 24 months
Population: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: Magnetic Resonance Imaging (MRI) | Post-Operation 6 months | Normal | 0 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: Magnetic Resonance Imaging (MRI) | Post-Operation 6 months | Abnormal | 68 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: Magnetic Resonance Imaging (MRI) | 12 months | Normal | 0 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: Magnetic Resonance Imaging (MRI) | 12 months | Abnormal | 61 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: Magnetic Resonance Imaging (MRI) | 24 months | Normal | 0 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: Magnetic Resonance Imaging (MRI) | 24 months | Abnormal | 52 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: Magnetic Resonance Imaging (MRI) | 24 months | Normal | 0 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: Magnetic Resonance Imaging (MRI) | Post-Operation 6 months | Normal | 0 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: Magnetic Resonance Imaging (MRI) | 12 months | Abnormal | 67 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: Magnetic Resonance Imaging (MRI) | Post-Operation 6 months | Abnormal | 67 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: Magnetic Resonance Imaging (MRI) | 24 months | Abnormal | 62 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: Magnetic Resonance Imaging (MRI) | 12 months | Normal | 0 Participants |
Secondary
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.
Time frame: Post-Operation 6 months, 12 months, 24 months
Population: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: X-ray | Post-Operation 6 months | Normal | 0 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: X-ray | Post-Operation 6 months | Abnormal | 67 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: X-ray | 12 months | Normal | 1 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: X-ray | 12 months | Abnormal | 60 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: X-ray | 24 months | Normal | 0 Participants |
| The Biosure Regenesorb Interference Screw | Imaging Evaluation: X-ray | 24 months | Abnormal | 51 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: X-ray | 24 months | Normal | 0 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: X-ray | Post-Operation 6 months | Normal | 1 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: X-ray | 12 months | Abnormal | 64 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: X-ray | Post-Operation 6 months | Abnormal | 65 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: X-ray | 24 months | Abnormal | 61 Participants |
| The BIOSURE HA Interference Screw | Imaging Evaluation: X-ray | 12 months | Normal | 1 Participants |
Secondary
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).
Time frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months
Population: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Biosure Regenesorb Interference Screw | International Knee Documentation Committee (IKDC) Score | Pre-Operation | 66.75 score on a scale | Standard Deviation 12.95 |
| The Biosure Regenesorb Interference Screw | International Knee Documentation Committee (IKDC) Score | Post-Operation 6 months | 80.98 score on a scale | Standard Deviation 8.07 |
| The Biosure Regenesorb Interference Screw | International Knee Documentation Committee (IKDC) Score | 12 months | 88.83 score on a scale | Standard Deviation 9.24 |
| The Biosure Regenesorb Interference Screw | International Knee Documentation Committee (IKDC) Score | 24 months | 91.41 score on a scale | Standard Deviation 8.38 |
| The BIOSURE HA Interference Screw | International Knee Documentation Committee (IKDC) Score | 24 months | 92.90 score on a scale | Standard Deviation 6.87 |
| The BIOSURE HA Interference Screw | International Knee Documentation Committee (IKDC) Score | Pre-Operation | 65.50 score on a scale | Standard Deviation 15.41 |
| The BIOSURE HA Interference Screw | International Knee Documentation Committee (IKDC) Score | 12 months | 91.00 score on a scale | Standard Deviation 7.45 |
| The BIOSURE HA Interference Screw | International Knee Documentation Committee (IKDC) Score | Post-Operation 6 months | 80.01 score on a scale | Standard Deviation 8.6 |
Secondary
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.
Time frame: Post-Operation 6 months, 12 months, 24 months
Population: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| The Biosure Regenesorb Interference Screw | Lachman Test | Post-Operation 6 months | Negative | 68 Participants |
| The Biosure Regenesorb Interference Screw | Lachman Test | Post-Operation 6 months | Positive | 0 Participants |
| The Biosure Regenesorb Interference Screw | Lachman Test | 12 months | Negative | 61 Participants |
| The Biosure Regenesorb Interference Screw | Lachman Test | 12 months | Positive | 0 Participants |
| The Biosure Regenesorb Interference Screw | Lachman Test | 24 months | Negative | 53 Participants |
| The Biosure Regenesorb Interference Screw | Lachman Test | 24 months | Positive | 0 Participants |
| The BIOSURE HA Interference Screw | Lachman Test | 24 months | Negative | 61 Participants |
| The BIOSURE HA Interference Screw | Lachman Test | Post-Operation 6 months | Negative | 67 Participants |
| The BIOSURE HA Interference Screw | Lachman Test | 12 months | Positive | 0 Participants |
| The BIOSURE HA Interference Screw | Lachman Test | Post-Operation 6 months | Positive | 0 Participants |
| The BIOSURE HA Interference Screw | Lachman Test | 24 months | Positive | 0 Participants |
| The BIOSURE HA Interference Screw | Lachman Test | 12 months | Negative | 67 Participants |
Secondary
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).
Time frame: Pre-Operation, Post-Operation 6 months, 24 months
Population: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Biosure Regenesorb Interference Screw | Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation | Pre-Operation | 72.42 score on a scale | Standard Deviation 14.41 |
| The Biosure Regenesorb Interference Screw | Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation | Post-Operation 6 months | 87.35 score on a scale | Standard Deviation 12.54 |
| The Biosure Regenesorb Interference Screw | Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation | 24 months | 94.22 score on a scale | Standard Deviation 8.46 |
| The BIOSURE HA Interference Screw | Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation | Pre-Operation | 70.19 score on a scale | Standard Deviation 16.61 |
| The BIOSURE HA Interference Screw | Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation | Post-Operation 6 months | 87.14 score on a scale | Standard Deviation 11.67 |
| The BIOSURE HA Interference Screw | Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation | 24 months | 94.96 score on a scale | Standard Deviation 7.32 |