Trial Outcomes & Findings for Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese (NCT NCT04012567)
NCT ID: NCT04012567
Last Updated: 2025-03-25
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
12 months
Results posted on
2025-03-25
Participant Flow
One participant enrolled in the study was excluded because their cruciate ligament was found to be unbroken during operation.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
70
|
|
Overall Study
COMPLETED
|
68
|
69
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
The Biosure Regenesorb Interference Screw
n=69 Participants
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.
|
The BIOSURE HA Interference Screw
n=70 Participants
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.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.12 years
STANDARD_DEVIATION 8.90 • n=69 Participants
|
33.69 years
STANDARD_DEVIATION 9.89 • n=70 Participants
|
31.91 years
STANDARD_DEVIATION 9.54 • n=139 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=69 Participants
|
13 Participants
n=70 Participants
|
28 Participants
n=139 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=69 Participants
|
57 Participants
n=70 Participants
|
111 Participants
n=139 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
24.31 kg/m^2
STANDARD_DEVIATION 3.29 • n=69 Participants
|
24.78 kg/m^2
STANDARD_DEVIATION 3.14 • n=70 Participants
|
24.55 kg/m^2
STANDARD_DEVIATION 3.21 • n=139 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
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).
Outcome measures
| Measure |
The Biosure Regenesorb Interference Screw
n=69 Participants
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.
|
The BIOSURE HA Interference Screw
n=70 Participants
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.
|
|---|---|---|
|
Lysholm Knee Scoring Scale 12 Months After Operation
|
92.49 score on a scale
Standard Deviation 10.61
|
94.14 score on a scale
Standard Deviation 7.13
|
SECONDARY outcome
Timeframe: Pre-Operation, Post-Operation 6 months, 24 monthsPopulation: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
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).
Outcome measures
| Measure |
The Biosure Regenesorb Interference Screw
n=69 Participants
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.
|
The BIOSURE HA Interference Screw
n=70 Participants
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.
|
|---|---|---|
|
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
|
70.19 score on a scale
Standard Deviation 16.61
|
|
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
|
87.14 score on a scale
Standard Deviation 11.67
|
|
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
|
94.96 score on a scale
Standard Deviation 7.32
|
SECONDARY outcome
Timeframe: Pre-Operation, Post-Operation 6 months, 12 months, 24 monthsPopulation: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
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).
Outcome measures
| Measure |
The Biosure Regenesorb Interference Screw
n=69 Participants
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.
|
The BIOSURE HA Interference Screw
n=70 Participants
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.
|
|---|---|---|
|
International Knee Documentation Committee (IKDC) Score
Pre-Operation
|
66.75 score on a scale
Standard Deviation 12.95
|
65.50 score on a scale
Standard Deviation 15.41
|
|
International Knee Documentation Committee (IKDC) Score
Post-Operation 6 months
|
80.98 score on a scale
Standard Deviation 8.07
|
80.01 score on a scale
Standard Deviation 8.60
|
|
International Knee Documentation Committee (IKDC) Score
12 months
|
88.83 score on a scale
Standard Deviation 9.24
|
91.00 score on a scale
Standard Deviation 7.45
|
|
International Knee Documentation Committee (IKDC) Score
24 months
|
91.41 score on a scale
Standard Deviation 8.38
|
92.90 score on a scale
Standard Deviation 6.87
|
SECONDARY outcome
Timeframe: Post-Operation 6 months, 12 months, 24 monthsPopulation: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
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.
Outcome measures
| Measure |
The Biosure Regenesorb Interference Screw
n=68 Participants
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.
|
The BIOSURE HA Interference Screw
n=67 Participants
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.
|
|---|---|---|
|
Drawer Test: Anterior
Post-Operation 6 months · Negative
|
68 Participants
|
67 Participants
|
|
Drawer Test: Anterior
Post-Operation 6 months · Postive
|
0 Participants
|
0 Participants
|
|
Drawer Test: Anterior
12 months · Negative
|
61 Participants
|
67 Participants
|
|
Drawer Test: Anterior
12 months · Postive
|
0 Participants
|
0 Participants
|
|
Drawer Test: Anterior
24 months · Negative
|
53 Participants
|
61 Participants
|
|
Drawer Test: Anterior
24 months · Postive
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-Operation 6 months, 12 months, 24 monthsPopulation: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
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.
Outcome measures
| Measure |
The Biosure Regenesorb Interference Screw
n=68 Participants
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.
|
The BIOSURE HA Interference Screw
n=67 Participants
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.
|
|---|---|---|
|
Drawer Test: Posterior
12 months · Positive
|
0 Participants
|
0 Participants
|
|
Drawer Test: Posterior
Post-Operation 6 months · Negative
|
68 Participants
|
66 Participants
|
|
Drawer Test: Posterior
Post-Operation 6 months · Positive
|
0 Participants
|
1 Participants
|
|
Drawer Test: Posterior
12 months · Negative
|
61 Participants
|
67 Participants
|
|
Drawer Test: Posterior
24 months · Negative
|
49 Participants
|
57 Participants
|
|
Drawer Test: Posterior
24 months · Positive
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-Operation 6 months, 12 months, 24 monthsPopulation: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
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.
Outcome measures
| Measure |
The Biosure Regenesorb Interference Screw
n=68 Participants
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.
|
The BIOSURE HA Interference Screw
n=67 Participants
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.
|
|---|---|---|
|
Lachman Test
Post-Operation 6 months · Negative
|
68 Participants
|
67 Participants
|
|
Lachman Test
Post-Operation 6 months · Positive
|
0 Participants
|
0 Participants
|
|
Lachman Test
12 months · Negative
|
61 Participants
|
67 Participants
|
|
Lachman Test
12 months · Positive
|
0 Participants
|
0 Participants
|
|
Lachman Test
24 months · Negative
|
53 Participants
|
61 Participants
|
|
Lachman Test
24 months · Positive
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-Operation 6 months, 12 months, 24 monthsPopulation: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
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.
Outcome measures
| Measure |
The Biosure Regenesorb Interference Screw
n=67 Participants
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.
|
The BIOSURE HA Interference Screw
n=66 Participants
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.
|
|---|---|---|
|
Imaging Evaluation: X-ray
Post-Operation 6 months · Normal
|
0 Participants
|
1 Participants
|
|
Imaging Evaluation: X-ray
Post-Operation 6 months · Abnormal
|
67 Participants
|
65 Participants
|
|
Imaging Evaluation: X-ray
12 months · Normal
|
1 Participants
|
1 Participants
|
|
Imaging Evaluation: X-ray
12 months · Abnormal
|
60 Participants
|
64 Participants
|
|
Imaging Evaluation: X-ray
24 months · Normal
|
0 Participants
|
0 Participants
|
|
Imaging Evaluation: X-ray
24 months · Abnormal
|
51 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Post-Operation 6 months, 12 months, 24 monthsPopulation: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
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.
Outcome measures
| Measure |
The Biosure Regenesorb Interference Screw
n=67 Participants
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.
|
The BIOSURE HA Interference Screw
n=66 Participants
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.
|
|---|---|---|
|
Imaging Evaluation: Computed Tomography (CT)
Post-op 6 months · Normal
|
0 Participants
|
0 Participants
|
|
Imaging Evaluation: Computed Tomography (CT)
Post-op 6 months · Abnormal
|
67 Participants
|
66 Participants
|
|
Imaging Evaluation: Computed Tomography (CT)
12 months · Normal
|
0 Participants
|
0 Participants
|
|
Imaging Evaluation: Computed Tomography (CT)
12 months · Abnormal
|
61 Participants
|
66 Participants
|
|
Imaging Evaluation: Computed Tomography (CT)
24 months · Normal
|
0 Participants
|
0 Participants
|
|
Imaging Evaluation: Computed Tomography (CT)
24 months · Abnormal
|
50 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Post-Operation 6 months, 12 months, 24 monthsPopulation: Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated.
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.
Outcome measures
| Measure |
The Biosure Regenesorb Interference Screw
n=68 Participants
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.
|
The BIOSURE HA Interference Screw
n=67 Participants
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.
|
|---|---|---|
|
Imaging Evaluation: Magnetic Resonance Imaging (MRI)
Post-Operation 6 months · Normal
|
0 Participants
|
0 Participants
|
|
Imaging Evaluation: Magnetic Resonance Imaging (MRI)
Post-Operation 6 months · Abnormal
|
68 Participants
|
67 Participants
|
|
Imaging Evaluation: Magnetic Resonance Imaging (MRI)
12 months · Normal
|
0 Participants
|
0 Participants
|
|
Imaging Evaluation: Magnetic Resonance Imaging (MRI)
12 months · Abnormal
|
61 Participants
|
67 Participants
|
|
Imaging Evaluation: Magnetic Resonance Imaging (MRI)
24 months · Normal
|
0 Participants
|
0 Participants
|
|
Imaging Evaluation: Magnetic Resonance Imaging (MRI)
24 months · Abnormal
|
52 Participants
|
62 Participants
|
Adverse Events
The Biosure Regenesorb Interference Screw
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
The BIOSURE HA Interference Screw
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
The Biosure Regenesorb Interference Screw
n=69 participants at risk
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.
|
The BIOSURE HA Interference Screw
n=70 participants at risk
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.
|
|---|---|---|
|
General disorders
Prepuce balanitis, prepuce too long
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Injury, poisoning and procedural complications
Meniscus Injury of the right knee
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
Left knee anterior cruciate ligament rupture,lateral meniscus root tear
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
Foreign body reaction
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Vascular disorders
Thrombosis:middle & lower left superficial femoral, popliteal, posterior tibial,& intermuscular vein
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
Pharyngeal disorder
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
Anterior cruciate ligament injury in right knee, meniscus injury in right knee
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
Other adverse events
| Measure |
The Biosure Regenesorb Interference Screw
n=69 participants at risk
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.
|
The BIOSURE HA Interference Screw
n=70 participants at risk
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.
|
|---|---|---|
|
General disorders
SWELLING OF LEFT KNEE
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
RIGHT PLANTAR FASCIITIS
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION (URI)
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
LIGAMENT STRAIN IN LEFT KNEE
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Nervous system disorders
INSOMNIA
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
INJURY OF POSTERIOR HORN OF MENISCUS ON THE LEFT KNEE
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
WOUND PAIN
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
8.6%
6/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Skin and subcutaneous tissue disorders
FLAT WART
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Immune system disorders
ALLERGY
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Skin and subcutaneous tissue disorders
PERIFOLLICULAR KERATOSIS
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Endocrine disorders
HYPERCHOLESTEROLEMIA
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
SYMPTOMS OF LOW GRADE FEVER
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Renal and urinary disorders
HYPERURICEMIA
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
ACROMIAL IMPINGEMENT SYNDROME
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Reproductive system and breast disorders
MENSTRUAL DISORDER
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
LEFT PLANTAR FASCIITIS
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Gastrointestinal disorders
POSTOPERATIVE ANESTHESIA GASTROINTESTINAL REACTION
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Endocrine disorders
POSSIBLE HYPOGLYCAEMIA
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
FEVER
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Renal and urinary disorders
FREQUENT URINATION
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
QUADRICEPS ATROPHY
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
JOINT PAIN
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGOPHARYNGITIS
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Psychiatric disorders
ANXIETY STATE
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
SOFT TISSUE STRAINS OF RIGHT FOOT
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
SWELLING IN THE LEFT KNEE
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
INFLAMMATION
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
RIGHT KNEE OSTEOARTHRITIS AGGRAVATED
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Gastrointestinal disorders
CHRONIC GASTRITIS
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
2.9%
2/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Eye disorders
CONJUNCTIVITIS OF THE RIGHT EYE
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Vascular disorders
NASAL BLEEDING
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Skin and subcutaneous tissue disorders
INCISION REDNESS AND SWELLING
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
SYNOVITIS OF THE RIGHT KNEE
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Hepatobiliary disorders
FOCAL NODULAR HYPERPLASIA OF LIVER
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
DISUSE OSTEOPOROSIS OF THE RIGHT KNEE
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
2.9%
2/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
RIGHT QUADRICEPS FEMORIS MUSCLE ATROPHY
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
SWELLING IN THE RIGHT KNEE
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
LEFT QUADRICEPS ATROPHY
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
SLIGHT SWELLING OF THE LEFT KNEE JOINT
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
SYMPTOMS OF FEVER
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Injury, poisoning and procedural complications
SOFT TISSUE CONTUSION OF LEFT KNEE
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS STENOSANS OF STYLOID PROCESS OF RADIUS OF LEFT WRIST
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Reproductive system and breast disorders
IRREGULAR PERIODS
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Injury, poisoning and procedural complications
FALL INDUCED PAIN IN RIGHT KNEE JOINT FOR 3 DAYS
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Nervous system disorders
NUMBNESS IN THE MEDIAL LEG
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
ANTERIOR TISSUE SWELLING OF RIGHT KNEE
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN THE RIGHT KNEE JOINT CAUSED BY SPRAIN
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
BONE MARROW TUNNEL CYST OF THE RIGHT KNEE TIBIA
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
FEVER SYMPTOM
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Skin and subcutaneous tissue disorders
ECZEMATOID DERMATITIS
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC PHARYNGITIS
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
POSTOPERATIVE DYSFUNCTION OF LEFT KNEE JOINT TRAUMA
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
PAIN IN THE WOUND
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
ATROPHY OF THE QUADRICEPS FEMORIS OF THE LEFT LOWER EXTREMITY
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
TRAUMATIC ARTHRITIS
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
FOREIGN BODY REACTION
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
INFLAMMATION
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Vascular disorders
THROMBOSIS OF RIGHT LOWER EXTREMITY
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Cardiac disorders
PALPITATE
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Vascular disorders
HYPERLIPIDEMIA WITH ATHEROSCLEROSIS
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
HYPERTENSION
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
2.9%
2/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Skin and subcutaneous tissue disorders
FOLLICULITIS
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
SWELLING OF SOFT TISSUE AROUND THE LEFT KNEE
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Skin and subcutaneous tissue disorders
SCROTAL INFLAMMATION
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Injury, poisoning and procedural complications
LEFT KNEE CONTUSION
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
DISUSE OSTEOPOROSIS OF THE LEFT KNEE
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
RIGHT KNEE PAIN
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
RIGHT KNEE EFFUSION
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
SWELLING IN THE RIGHT LOWER EXTREMITY
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
2.9%
2/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
OOR MOTION OF THE RIGHT KNEE JOINT (LACK OF EXERCISE AFTER SURGERY)
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Injury, poisoning and procedural complications
QUADRICEPS ATROPHY OF THE RIGHT LOWER LIMB
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
RIGHT RADIAL STYLOIDITIS
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Infections and infestations
CHRONIC VAGINITIS
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Skin and subcutaneous tissue disorders
SKIN PAPILLOMA（ FLAT WARTS)
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Vascular disorders
POSTOPERATIVE JOINT HEMATOMA
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
CHRONIC PROSTATITIS
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Metabolism and nutrition disorders
HYPERLIPIDEMIA
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NODULE
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Reproductive system and breast disorders
SECONDARY OLIGOMENORRHEA
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
KNEE PAIN IN RIGHT KNEE
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
MAMMARY PAIN
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
RIGHT KNEE PAIN
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Musculoskeletal and connective tissue disorders
RIGHT QUADRICEPS ATROPHY
|
1.4%
1/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
0.00%
0/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Infections and infestations
ACUTE UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Injury, poisoning and procedural complications
CAT SCRATCH
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Renal and urinary disorders
URINE OCCULT BLOOD
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Skin and subcutaneous tissue disorders
VERRUCA VULGARIS
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
General disorders
ABDOMINAL PAIN
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
|
Eye disorders
CONJUNCTIVITIS OF BOTH EYES
|
0.00%
0/69 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
1.4%
1/70 • Adverse events were collected upon device implantation through 24 months, approximately 740 days.
|
Additional Information
Senior Manager Clinical Compliance
Smith+Nephew, Inc
Phone: +44 7811 407089
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60