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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.
The clinical trial is designed to be a prospective, multi-center, randomized, evaluator-blinded, parallel-controlled, non-inferiority trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Biosure Regenesorb Interference Screw | Experimental | The Biosure Regenesorb Interference Screw, an absorbable screw designed with an open structure and made of biocomposite material, is used to fix ligaments, tendons, soft tissues or bone-tendon-bone grafts in knee surgery. |
|
| The BIOSURE HA Interference Screw | Active Comparator | The Biosure HA Interference Screw, an absorbable screw made of biocomposite material, is used to fix ligaments, tendons, soft tissues or bone-tendon-bone grafts in knee surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational device: Biosure Regenesorb Interference Screw | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Subjects must meet all of the inclusion criteria:
Exclusion Criteria:
Subjects with any of the following characteristics must be excluded from participation in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Xi Gong, Professor | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Southern Medical University | Guangzhou | Guangdong | 510000 | China | ||
| Peking University Third Hospital |
One participant enrolled in the study was excluded because their cruciate ligament was found to be unbroken during operation.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
Adverse events were collected upon device implantation through 24 months, approximately 740 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prepuce balanitis, prepuce too long | General disorders | Systematic Assessment | definitely not related to device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INJURY OF POSTERIOR HORN OF MENISCUS ON THE LEFT KNEE | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Compliance | Smith+Nephew, Inc | +44 7811 407089 | datasharing.gcs@smith-nephew.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2020 | Nov 13, 2024 | Prot_SAP_000.pdf |
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|
| Control device: BIOSURE HA Interference Screw | Device | 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. |
|
| Pre-Operation, Post-Operation 6 months, 24 months |
| International Knee Documentation Committee (IKDC) Score | The International Knee Documentation Committee (IKDC) score is composed of a knee evaluation form (10 items) and a knee ligament examination form (8 items), involving joint pain, sport level and ability of daily activities. The total score is transformed to a scale ranging from 0 to 100, where 0 represents the lowest level of knee function and highest level of symptoms (i.e., worst outcome), and 100 represents the highest level of knee function and lowest level of symptoms (i.e., best outcome). | Pre-Operation, Post-Operation 6 months, 12 months, 24 months |
| Drawer Test: Anterior | The Anterior Drawer Test is used for anterior cruciate ligament (ACL) examination with an outcome of either negative or positive. The test was performed with the participant lying supine with the knee flexed at 90 degrees and the foot stabilized flat on the table. The examiner then grasped the tibia and applied an anterior force to assess displacement. The test outcome was measured by the number of participants with a negative or positive result. A positive test indicated forward straight instability, defined as the tibia being displaced forward by 5 millimeters (mm) or more compared to the uninjured side. | Post-Operation 6 months, 12 months, 24 months |
| Drawer Test: Posterior | The Posterior Drawer Test is used for posterior cruciate ligament (PCL) examination with an outcome of either negative or positive. The test was performed with the participant lying supine with the knee flexed at 90 degrees. The examiner placed both hands on the proximal lower leg (just below the knee joint) with thumbs on the tibial tuberosity then attempted to translate the lower leg posteriorly. The test outcome was measured by the number of participants with a negative or positive result. A positive test indicated a lack of end feel or excessive posterior translation. | Post-Operation 6 months, 12 months, 24 months |
| Lachman Test | The Lachman Test assessed integrity of the anterior cruciate ligament (ACL) with an outcome of either negative or positive. The test was performed with the participant lying supine with the knee flexed to 20-30 degrees and the injured limb slightly rotated outward. The examiner immobilized the lower end of the femur with one hand and pressed the posterior side of the upper end of the tibia forward or backward. The test outcome was measured by the number of participants with a negative or positive result. A positive test indicated excessive anterior translation of the tibia greater than the uninjured side along with a soft end feel. | Post-Operation 6 months, 12 months, 24 months |
| Imaging Evaluation: X-ray | Radiographic assessment taken from x-ray images to evaluate the general view of bone. The assessment measured the number of participants categorized with either a normal or abnormal imaging evaluation. | Post-Operation 6 months, 12 months, 24 months |
| Imaging Evaluation: Computed Tomography (CT) | Radiographic assessment taken from Computed Tomography (CT) images to evaluate specific view of bone. The assessment measured the number of participants categorized with either a normal or abnormal imaging evaluation. | Post-Operation 6 months, 12 months, 24 months |
| Imaging Evaluation: Magnetic Resonance Imaging (MRI) | Radiographic assessment taken from Magnetic Resonance Imaging (MRI) to evaluate ligament. The assessment measured the number of participants categorized with either a normal or abnormal imaging evaluation. | Post-Operation 6 months, 12 months, 24 months |
| Beijing |
| Haidian District |
| 100191 |
| China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410000 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | 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. |
|
|
| 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). | Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operation, Post-Operation 6 months, 24 months |
|
|
|
| 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). | Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Pre-Operation, Post-Operation 6 months, 12 months, 24 months |
|
|
|
| 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. | Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated. | Posted | Count of Participants | Participants | Post-Operation 6 months, 12 months, 24 months |
|
|
|
| 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. | Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated. | Posted | Count of Participants | Participants | Post-Operation 6 months, 12 months, 24 months |
|
|
|
| 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. | Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated. | Posted | Count of Participants | Participants | Post-Operation 6 months, 12 months, 24 months |
|
|
|
| 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. | Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated. | Posted | Count of Participants | Participants | Post-Operation 6 months, 12 months, 24 months |
|
|
|
| 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. | Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated. | Posted | Count of Participants | Participants | Post-Operation 6 months, 12 months, 24 months |
|
|
|
| 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. | Full Analysis Set (FAS) included participants with at least one effectiveness evaluation that provided data for the time frame indicated. | Posted | Count of Participants | Participants | Post-Operation 6 months, 12 months, 24 months |
|
|
|
| 0 |
| 69 |
| 3 |
| 69 |
| 30 |
| 69 |
| EG001 | 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. | 0 | 70 | 3 | 70 | 26 | 70 |
|
| Meniscus Injury of the right knee | Injury, poisoning and procedural complications | Systematic Assessment | possibly related to the device |
|
| Left knee anterior cruciate ligament rupture,lateral meniscus root tear | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
|
| Foreign body reaction | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
|
| Thrombosis:middle & lower left superficial femoral, popliteal, posterior tibial,& intermuscular vein | Vascular disorders | Systematic Assessment | definitely not related to device |
|
| Pharyngeal disorder | General disorders | Systematic Assessment | definitely not related to device |
|
| Anterior cruciate ligament injury in right knee, meniscus injury in right knee | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
|
|
| WOUND PAIN | General disorders | Systematic Assessment | possibly related to the device |
|
| FLAT WART | Skin and subcutaneous tissue disorders | Systematic Assessment | definitely not related to device |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
|
| ALLERGY | Immune system disorders | Systematic Assessment | possibly related to the device |
|
| PERIFOLLICULAR KERATOSIS | Skin and subcutaneous tissue disorders | Systematic Assessment | definitely not related to device |
|
| WOUND PAIN | General disorders | Systematic Assessment | possibly related to the device |
|
| HYPERCHOLESTEROLEMIA | Endocrine disorders | Systematic Assessment | definitely not related to device |
|
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
|
| SYMPTOMS OF LOW GRADE FEVER | General disorders | Systematic Assessment | definitely not related to device |
|
| HYPERURICEMIA | Renal and urinary disorders | Systematic Assessment | possibly related to the device |
|
| ACROMIAL IMPINGEMENT SYNDROME | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
|
| SWELLING OF LEFT KNEE | General disorders | Systematic Assessment | possibly related to the device |
|
| RIGHT PLANTAR FASCIITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| UPPER RESPIRATORY INFECTION (URI) | Infections and infestations | Systematic Assessment | definitely not related to device |
|
| ACUTE KIDNEY INJURY | Renal and urinary disorders | Systematic Assessment | possibly related to the device |
|
| LIGAMENT STRAIN IN LEFT KNEE | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
|
| INSOMNIA | Nervous system disorders | Systematic Assessment | definitely not related to device |
|
| MENSTRUAL DISORDER | Reproductive system and breast disorders | Systematic Assessment | definitely not related to device |
|
| LEFT PLANTAR FASCIITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| POSTOPERATIVE ANESTHESIA GASTROINTESTINAL REACTION | Gastrointestinal disorders | Systematic Assessment | definitely not related to device |
|
| POSSIBLE HYPOGLYCAEMIA | Endocrine disorders | Systematic Assessment | possibly related to the device |
|
| FEVER | General disorders | Systematic Assessment | possibly related to the device |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | definitely not related to device |
|
| FREQUENT URINATION | Renal and urinary disorders | Systematic Assessment | definitely not related to device |
|
| QUADRICEPS ATROPHY | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| JOINT PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
|
| LARYNGOPHARYNGITIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | definitely not related to device |
|
| ANXIETY STATE | Psychiatric disorders | Systematic Assessment | definitely not related to device |
|
| SOFT TISSUE STRAINS OF RIGHT FOOT | General disorders | Systematic Assessment | definitely not related to device |
|
| SWELLING IN THE LEFT KNEE | General disorders | Systematic Assessment | possibly related to the device |
|
| QUADRICEPS ATROPHY | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| INFLAMMATION | General disorders | Systematic Assessment | definitely not related to device |
|
| RIGHT KNEE OSTEOARTHRITIS AGGRAVATED | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
|
| CHRONIC GASTRITIS | Gastrointestinal disorders | Systematic Assessment | definitely not related to device |
|
| CONJUNCTIVITIS OF THE RIGHT EYE | Eye disorders | Systematic Assessment | definitely not related to device |
|
| NASAL BLEEDING | Vascular disorders | Systematic Assessment | definitely not related to device |
|
| INCISION REDNESS AND SWELLING | Skin and subcutaneous tissue disorders | Systematic Assessment | possibly related to the device |
|
| HEADACHE | Nervous system disorders | Systematic Assessment | definitely not related to device |
|
| DIZZINESS | Nervous system disorders | Systematic Assessment | definitely not related to device |
|
| SYNOVITIS OF THE RIGHT KNEE | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| FOCAL NODULAR HYPERPLASIA OF LIVER | Hepatobiliary disorders | Systematic Assessment | definitely not related to device |
|
| DISUSE OSTEOPOROSIS OF THE RIGHT KNEE | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| RIGHT QUADRICEPS FEMORIS MUSCLE ATROPHY | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| SWELLING IN THE RIGHT KNEE | General disorders | Systematic Assessment | possibly related to the device |
|
| LEFT QUADRICEPS ATROPHY | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| SLIGHT SWELLING OF THE LEFT KNEE JOINT | General disorders | Systematic Assessment | possibly related to the device |
|
| SYMPTOMS OF FEVER | General disorders | Systematic Assessment | possibly related to the device |
|
| SOFT TISSUE CONTUSION OF LEFT KNEE | Injury, poisoning and procedural complications | Systematic Assessment | possibly related to the device |
|
| TENOSYNOVITIS STENOSANS OF STYLOID PROCESS OF RADIUS OF LEFT WRIST | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| IRREGULAR PERIODS | Reproductive system and breast disorders | Systematic Assessment | definitely not related to device |
|
| FALL INDUCED PAIN IN RIGHT KNEE JOINT FOR 3 DAYS | Injury, poisoning and procedural complications | Systematic Assessment | definitely not related to device |
|
| NUMBNESS IN THE MEDIAL LEG | Nervous system disorders | Systematic Assessment | definitely not related to device |
|
| ANTERIOR TISSUE SWELLING OF RIGHT KNEE | General disorders | Systematic Assessment | definitely not related to device |
|
| PAIN IN THE RIGHT KNEE JOINT CAUSED BY SPRAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| BONE MARROW TUNNEL CYST OF THE RIGHT KNEE TIBIA | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
|
| FEVER SYMPTOM | General disorders | Systematic Assessment | definitely not related to device |
|
| ECZEMATOID DERMATITIS | Skin and subcutaneous tissue disorders | Systematic Assessment | possibly related to the device |
|
| CHRONIC PHARYNGITIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | definitely not related to device |
|
| POSTOPERATIVE DYSFUNCTION OF LEFT KNEE JOINT TRAUMA | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| PAIN IN THE WOUND | General disorders | Systematic Assessment | possibly related to the device |
|
| ATROPHY OF THE QUADRICEPS FEMORIS OF THE LEFT LOWER EXTREMITY | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| GASTROESOPHAGEAL REFLUX | Gastrointestinal disorders | Systematic Assessment | definitely not related to device |
|
| TRAUMATIC ARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| FOREIGN BODY REACTION | General disorders | Systematic Assessment | possibly related to the device |
|
| INFLAMMATION | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
|
| URTICARIA | Skin and subcutaneous tissue disorders | Systematic Assessment | definitely not related to device |
|
| THROMBOSIS OF RIGHT LOWER EXTREMITY | Vascular disorders | Systematic Assessment | possibly related to the device |
|
| PALPITATE | Cardiac disorders | Systematic Assessment | definitely not related to device |
|
| HYPERLIPIDEMIA WITH ATHEROSCLEROSIS | Vascular disorders | Systematic Assessment | definitely not related to device |
|
| HYPERTENSION | General disorders | Systematic Assessment | definitely not related to device |
|
| ECZEMA | Skin and subcutaneous tissue disorders | Systematic Assessment | definitely not related to device |
|
| FOLLICULITIS | Skin and subcutaneous tissue disorders | Systematic Assessment | definitely not related to device |
|
| SWELLING OF SOFT TISSUE AROUND THE LEFT KNEE | General disorders | Systematic Assessment | definitely not related to device |
|
| SCROTAL INFLAMMATION | Skin and subcutaneous tissue disorders | Systematic Assessment | definitely not related to device |
|
| LEFT KNEE CONTUSION | Injury, poisoning and procedural complications | Systematic Assessment | definitely not related to device |
|
| DISUSE OSTEOPOROSIS OF THE LEFT KNEE | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| RIGHT KNEE PAIN | General disorders | Systematic Assessment | definitely not related to device |
|
| RIGHT KNEE EFFUSION | General disorders | Systematic Assessment | possibly related to the device |
|
| SWELLING IN THE RIGHT LOWER EXTREMITY | General disorders | Systematic Assessment | possibly related to the device |
|
| OOR MOTION OF THE RIGHT KNEE JOINT (LACK OF EXERCISE AFTER SURGERY) | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related to the device |
|
| QUADRICEPS ATROPHY OF THE RIGHT LOWER LIMB | Injury, poisoning and procedural complications | Systematic Assessment | possibly related to the device |
|
| RIGHT RADIAL STYLOIDITIS | General disorders | Systematic Assessment | definitely not related to device |
|
| CHRONIC VAGINITIS | Infections and infestations | Systematic Assessment | definitely not related to device |
|
| SKIN PAPILLOMA（ FLAT WARTS) | Skin and subcutaneous tissue disorders | Systematic Assessment | definitely not related to device |
|
| POSTOPERATIVE JOINT HEMATOMA | Vascular disorders | Systematic Assessment | definitely not related to device |
|
| CHRONIC PROSTATITIS | General disorders | Systematic Assessment | definitely not related to device |
|
| HYPERLIPIDEMIA | Metabolism and nutrition disorders | Systematic Assessment | definitely not related to device |
|
| THYROID NODULE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | definitely not related to device |
|
| SECONDARY OLIGOMENORRHEA | Reproductive system and breast disorders | Systematic Assessment | definitely not related to device |
|
| FEVER | General disorders | Systematic Assessment | possibly related to the device |
|
| ANTERIOR TISSUE SWELLING OF RIGHT KNEE | General disorders | Systematic Assessment | definitely not related to device |
|
| KNEE PAIN IN RIGHT KNEE | General disorders | Systematic Assessment | definitely not related to device |
|
| MAMMARY PAIN | General disorders | Systematic Assessment | definitely not related to device |
|
| RIGHT KNEE PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
|
| RIGHT QUADRICEPS ATROPHY | Musculoskeletal and connective tissue disorders | Systematic Assessment | definitely not related to device |
|
| ACUTE UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Systematic Assessment | definitely not related to device |
|
| CAT SCRATCH | Injury, poisoning and procedural complications | Systematic Assessment | definitely not related to device |
|
| URINARY TRACT INFECTION | Renal and urinary disorders | Systematic Assessment | definitely not related to device |
|
| URINE OCCULT BLOOD | Renal and urinary disorders | Systematic Assessment | definitely not related to device |
|
| VERRUCA VULGARIS | Skin and subcutaneous tissue disorders | Systematic Assessment | definitely not related to device |
|
| ABDOMINAL PAIN | General disorders | Systematic Assessment | definitely not related to device |
|
| CONJUNCTIVITIS OF BOTH EYES | Eye disorders | Systematic Assessment | definitely not related to device |
|
Not provided
| Post-Operation 6 months |
|
|
| 24 months |
|
|
| Post-Operation 6 months |
|
|
| 12 months |
|
|
| 24 months |
|
|
| Postive |
|
| 12 months |
|
|
| 24 months |
|
|
| Positive |
|
| 12 months |
|
|
| 24 months |
|
|
| Positive |
|
| 12 months |
|
|
| 24 months |
|
|
| Abnormal |
|
| 12 months |
|
|
| 24 months |
|
|
| Abnormal |
|
| 12 months |
|
|
| 24 months |
|
|
| Abnormal |
|
| 12 months |
|
|
| 24 months |
|
|