Not provided
Not provided
Not provided
Not provided
Not provided
Follow-up data for the last participant cannot be fully collected within the next year and cannot be entered on the website in time; therefore, we request approval to update the trial status to "Suspended."
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Traditional fracture fixation devices can cause corrosion, allergies, and stress shielding effects. They often require removal after healing, risking secondary damage. Recently, biodegradable materials have gained attention for their effective clinical use in fracture fixation. Absorbable bone nails, for example, eliminate the need for a second surgery, reducing pain and costs while avoiding infection and tissue re-injury. They do not corrode and are invisible on X-rays, allowing for thorough patient examination and better fracture healing assessment.
Traditional fracture internal fixation devices implanted in the human body for a long time will cause corrosion, allergy and adverse effects due to stress shielding effect, etc. Due to the non-absorbability of its own materials, it needs to be removed again after fracture healing, which is easy to cause secondary damage to patients. However, in recent years, biodegradable materials have attracted the attention of scholars. The fracture fixation made of biodegradable biomaterials has achieved better internal fixation effect in clinic. For example, the implantation of absorbable bone nails can enable patients to avoid a second surgery, reduce the pain and economic burden of patients, while avoiding the problems of infection and tissue re-injury caused by the second surgery. In addition, absorbable bone nails have no metal corrosion effect and are not visible under the X-ray line, which is conducive to comprehensive examination of the patient and further understanding of the fracture healing. Common biodegradable materials are polymer materials (such as polylactic acid), ceramic materials (such as calcium phosphate) and metal materials. Among them, the strength of polymer materials is lower, and the toughness of ceramic materials is poorer, while the bone nails made of natural silk protein are biocompatible, non-toxic, no irritant, no side-effective, no antigenic and no carcinogenic to tissues. It can be completely degraded into amino acids and peptides in the body, participate in human metabolism, and eventually be excreted from the body. Silk was first used as a surgical suture, which can be gradually absorbed and degraded by the body after wound healing, which protected patients from the pain of removing stitches. Animal experiments have shown that the use of silk protein gel and commonly used ethyl lactate to repair rabbit thigh bone injuries, with the number, thickness and gap of bone trabeculae as evaluation indexes, the result showed that the use of silk protein gel was more conducive to the repair of rabbit thigh bone injury, and was also closer to the regeneration of human bone. In addition, the silk was able to maintain 50% tension two months after implantation in the animals.
Therefore, the purpose of this clinical trial study was to evaluate the safety and effectiveness of biologic hollow bone screws for the fixation of fractures in the knee joint and ankle joint. Researchers can use the above results to provide better treatment for patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inion Freedom Screws | Active Comparator | Patients were treated with screws developed by Inion Oy, Finland for the fixation of fractures in the knee and ankle joints. |
|
| Biologic Hollow Bone Screws | Experimental | Patients were treated with screws developed by Jiangxi Sike Biotechnology, China for the fixation of fractures in the knee and ankle joints. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Comparator: Fracture Fixation (Inion Freedom Screws) | Device | Device: Absorbable screw for internal fixation of fracture. Patients were divided into the Inion Freedom Screws group and the Biological Hollow Bone Screws group according to the type of the screws they used. |
| Measure | Description | Time Frame |
|---|---|---|
| Cinical Fracture Healing Rate |
| 24 weeks after surgery+4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cinical Fracture Healing Rate |
| 12 weeks after surgery±1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic Data | It mainly includes the age, gender, place of birth and education level of the patient | Before surgery |
| History of Disease and Treatment | Medical history within 3 months before signing the informed consent, medication history, surgery history, smoking history, drinking history and allergy history within 1 month before signing the informed consent were asked. |
Inclusion criteria
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Air Force Medical University (Xijing Hospital) | Xi'an | Shaanxi | 710032 | China |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 21, 2024 | Apr 16, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 21, 2024 | Apr 16, 2025 | SAP_001.pdf |
Not provided
The experimental group was treated with biologic hollow bone screws (Jiangxi Sike Biotechnology, China); the control group was treated with Freedom Screws (Inion Oy, Finland).
Not provided
Not provided
The researchers can visually distinguish the experiment products and the control products, so the researchers cannot be blinded and the participants were blinded.
| Experimental: Fracture Fixation (Biological Hollow Bone Screws) | Device | Device: Absorbable screw for internal fixation of fracture. Patients were divided into the Inion Freedom Screws group and the Biological Hollow Bone Screws group according to the type of the screws they used. |
|
| Cinical Fracture Healing Rate |
| 48 weeks after surgery± 4 weeks |
| Cinical Fracture Healing Rate |
| 72 weeks after surgery± 4 weeks |
| Visual Analogue Scale (VAS) | In the Visual Analogue Scale (VAS), the minimum value is 0 and the maximum value is 10. The higher the score, the more severe the pain and the worse the outcome. A score of 0 means painless; A score of 1-3 means mild pain, tolerable; A score of 4-6 indicates moderate pain that affects sleep and is tolerable; A score of 7-10 indicates severe pain, unbearable pain, affecting appetite, and affecting sleep. | During the screening period |
| Visual Analogue Scale (VAS) | In the Visual Analogue Scale (VAS), the minimum value is 0 and the maximum value is 10. The higher the score, the more severe the pain and the worse the outcome. A score of 0 means painless; A score of 1-3 means mild pain, tolerable; A score of 4-6 indicates moderate pain that affects sleep and is tolerable; A score of 7-10 indicates severe pain, unbearable pain, affecting appetite, and affecting sleep. | Within 1 week after surgery (≤7 days) |
| Visual Analogue Scale (VAS) | In the Visual Analogue Scale (VAS), the minimum value is 0 and the maximum value is 10. The higher the score, the more severe the pain and the worse the outcome. A score of 0 means painless; A score of 1-3 means mild pain, tolerable; A score of 4-6 indicates moderate pain that affects sleep and is tolerable; A score of 7-10 indicates severe pain, unbearable pain, affecting appetite, and affecting sleep. | 6 weeks after surgery±1 week |
| Visual Analogue Scale (VAS) | In the Visual Analogue Scale (VAS), the minimum value is 0 and the maximum value is 10. The higher the score, the more severe the pain and the worse the outcome. A score of 0 means painless; A score of 1-3 means mild pain, tolerable; A score of 4-6 indicates moderate pain that affects sleep and is tolerable; A score of 7-10 indicates severe pain, unbearable pain, affecting appetite, and affecting sleep. | 12 weeks after surgery±1 week |
| Visual Analogue Scale (VAS) | In the Visual Analogue Scale (VAS), the minimum value is 0 and the maximum value is 10. A higher score indicates a more severe level of pain. A score of 0 means painless; A score of 1-3 means mild pain, tolerable; A score of 4-6 indicates moderate pain that affects sleep and is tolerable; A score of 7-10 indicates severe pain, unbearable pain, affecting appetite, and affecting sleep. | 24 weeks after surgery±4 weeks |
| Visual Analogue Scale (VAS) | In the Visual Analogue Scale (VAS), the minimum value is 0 and the maximum value is 10. The higher the score, the more severe the pain and the worse the outcome. A score of 0 means painless; A score of 1-3 means mild pain, tolerable; A score of 4-6 indicates moderate pain that affects sleep and is tolerable; A score of 7-10 indicates severe pain, unbearable pain, affecting appetite, and affecting sleep. | 48 weeks after surgery±4 weeks |
| Visual Analogue Scale (VAS) | In the Visual Analogue Scale (VAS), the minimum value is 0 and the maximum value is 10. The higher the score, the more severe the pain and the worse the outcome. A score of 0 means painless; A score of 1-3 means mild pain, tolerable; A score of 4-6 indicates moderate pain that affects sleep and is tolerable; A score of 7-10 indicates severe pain, unbearable pain, affecting appetite, and affecting sleep. | 72 weeks after surgery± 4 weeks |
| The American Knee Society (AKS) Clinical Rating System | AKS score is divided into two parts: knee score and functional score. The knee score includes pain, range of motion and stability, and the functional score includes the ability to walk and go up and down stairs. The knee score is an assessment of knee pain, stability, and range of motion. And the functional score is an assessment of walking ability and the ability to walk up and down stairs. The total score of AKS is 200 points, of which knee score and functional score are 100 points each. The higher the score, the better the status. If the score is negative, it is calculated as 0. | 6 weeks after surgery±1 week |
| The American Knee Society (AKS) Clinical Rating System | AKS score is divided into two parts: knee score and functional score. The knee score includes pain, range of motion and stability, and the functional score includes the ability to walk and go up and down stairs. The knee score is an assessment of knee pain, stability, and range of motion. And the functional score is an assessment of walking ability and the ability to walk up and down stairs. The total score of AKS is 200 points, of which knee score and functional score are 100 points each. The higher the score, the better the status. If the score is negative, it is calculated as 0. | 12 weeks after surgery±1 week |
| The American Knee Society (AKS) Clinical Rating System | AKS score is divided into two parts: knee score and functional score. The knee score includes pain, range of motion and stability, and the functional score includes the ability to walk and go up and down stairs. The knee score is an assessment of knee pain, stability, and range of motion. And the functional score is an assessment of walking ability and the ability to walk up and down stairs. The total score of AKS is 200 points, of which knee score and functional score are 100 points each. The higher the score, the better the status. If the score is negative, it is calculated as 0. | 24 weeks after surgery±4 weeks |
| The American Knee Society (AKS) Clinical Rating System | AKS score is divided into two parts: knee score and functional score. The knee score includes pain, range of motion and stability, and the functional score includes the ability to walk and go up and down stairs. The knee score is an assessment of knee pain, stability, and range of motion. And the functional score is an assessment of walking ability and the ability to walk up and down stairs. The total score of AKS is 200 points, of which knee score and functional score are 100 points each. The higher the score, the better the status. If the score is negative, it is calculated as 0. | 48 weeks after surgery±4 weeks |
| The American Knee Society (AKS) Clinical Rating System | AKS score is divided into two parts: knee score and functional score. The knee score includes pain, range of motion and stability, and the functional score includes the ability to walk and go up and down stairs. The knee score is an assessment of knee pain, stability, and range of motion. And the functional score is an assessment of walking ability and the ability to walk up and down stairs. The total score of AKS is 200 points, of which knee score and functional score are 100 points each. The higher the score, the better the status. If the score is negative, it is calculated as 0. | 72 weeks after surgery± 4 weeks |
| Mazur Ankle Joint Functional Evaluation | On the Mazur ankle joint functional evaluation, the highest score is 100, and a higher score indicates better ankle function. Excellent: >92 points, ankle joint without swelling pain, normal gait, free movement. Good: 87-92 points, ankle joint slight swelling pain, normal gait, range of motion up to 3/4 of normal. General: 65-86 points, pain during activity, only 1/2 of normal motion, normal gait, need to take non-steroidal anti-inflammatory drugs. Poor: <65 points, walking or resting pain, only 1/2 of normal range of motion, claudication, swollen ankle. | 6 weeks after surgery±1 week |
| Mazur Ankle Joint Functional Evaluation | On the Mazur ankle joint functional evaluation, the highest score is 100, and a higher score indicates better ankle function. Excellent: >92 points, ankle joint without swelling pain, normal gait, free movement. Good: 87-92 points, ankle joint slight swelling pain, normal gait, range of motion up to 3/4 of normal. General: 65-86 points, pain during activity, only 1/2 of normal motion, normal gait, need to take non-steroidal anti-inflammatory drugs. Poor: <65 points, walking or resting pain, only 1/2 of normal range of motion, claudication, swollen ankle. | 12 weeks after surgery±1 week |
| Mazur Ankle Joint Functional Evaluation | On the Mazur ankle joint functional evaluation, the highest score is 100, and a higher score indicates better ankle function. Excellent: >92 points, ankle joint without swelling pain, normal gait, free movement. Good: 87-92 points, ankle joint slight swelling pain, normal gait, range of motion up to 3/4 of normal. General: 65-86 points, pain during activity, only 1/2 of normal motion, normal gait, need to take non-steroidal anti-inflammatory drugs. Poor: <65 points, walking or resting pain, only 1/2 of normal range of motion, claudication, swollen ankle. | 24 weeks after surgery±4 weeks |
| Mazur Ankle Joint Functional Evaluation | On the Mazur ankle joint functional evaluation, the highest score is 100, and a higher score indicates better ankle function. Excellent: >92 points, ankle joint without swelling pain, normal gait, free movement. Good: 87-92 points, ankle joint slight swelling pain, normal gait, range of motion up to 3/4 of normal. General: 65-86 points, pain during activity, only 1/2 of normal motion, normal gait, need to take non-steroidal anti-inflammatory drugs. Poor: <65 points, walking or resting pain, only 1/2 of normal range of motion, claudication, swollen ankle. | 48 weeks after surgery±4 weeks |
| Mazur Ankle Joint Functional Evaluation | On the Mazur ankle joint functional evaluation, the highest score is 100, and a higher score indicates better ankle function. Excellent: >92 points, ankle joint without swelling pain, normal gait, free movement. Good: 87-92 points, ankle joint slight swelling pain, normal gait, range of motion up to 3/4 of normal. General: 65-86 points, pain during activity, only 1/2 of normal motion, normal gait, need to take non-steroidal anti-inflammatory drugs. Poor: <65 points, walking or resting pain, only 1/2 of normal range of motion, claudication, swollen ankle. | 72 weeks after surgery± 4 weeks |
| Before surgery |
| Bone Mineral Density (BMD) Examination | Bone Mineral Density (BMD) Examination | Before surgery |
| Blood Glucose Testing | Blood Glucose Testing | Before surgery |
| C-Reactive Protein | C-Reactive Protein | Before surgery |
| Examination of Infectious Diseases | Hepatitis B Surface Antigen (HBsAg) | Before surgery |
| Examination of Infectious Diseases | Hepatitis B Surface Antibody (HBsAb) | Before surgery |
| Examination of Infectious Diseases | Hepatitis B e-Antigen (HBeAg) | Before surgery |
| Examination of Infectious Diseases | Hepatitis B e-Antibody (HBeAb) | Before surgery |
| Examination of Infectious Diseases | Hepatitis B Core Antibody (HBcAb) | Before surgery |
| Examination of Infectious Diseases | Hepatitis Virus C-RNA / Hepatitis Virus C-Antibody (HCV-rna/HCV-Ab) | Before surgery |
| Examination of Infectious Diseases | Treponema Pallidum Particle Agglutination Assay (TPPA) | Before surgery |
| Examination of Infectious Diseases | Human Immunodeficiency Virus Antibody (HIV-Ab) | Before surgery |
| Record Surgical Information | Operation time | During Surgery |
| Record Surgical Information | Intraoperative blood loss | During Surgery |
| Record Surgical Information | Device usage | During Surgery |
| Vital Signs-Body Temperature | Body Temperature | Before surgery |
| Vital Signs-Respiration | Respiration | Before surgery |
| Vital Signs-Heart Rate | Heart Rate | Before surgery |
| Vital Signs-Blood Pressure | Blood Pressure | Before surgery |
| Vital Signs-Body Temperature | Body Temperature | During Surgery |
| Vital Signs-Respiration | Respiration | During Surgery |
| Vital Signs-Heart Rate | Heart Rate | During Surgery |
| Vital Signs-Blood Pressure | Blood Pressure | During Surgery |
| Vital Signs-Body Temperature | Body Temperature | Within 1 week after surgery (≤7 days) |
| Vital Signs-Respiration | Respiration | Within 1 week after surgery (≤7 days) |
| Vital Signs-Heart Rate | Heart Rate | Within 1 week after surgery (≤7 days) |
| Vital Signs-Blood Pressure | Blood Pressure | Within 1 week after surgery (≤7 days) |
| Vital Signs-Body Temperature | Body Temperature | 6 weeks after surgery±1 week |
| Vital Signs-Respiration | Respiration | 6 weeks after surgery±1 week |
| Vital Signs-Heart Rate | Heart Rate | 6 weeks after surgery±1 week |
| Vital Signs-Blood Pressure | Blood Pressure | 6 weeks after surgery±1 week |
| Vital Signs-Body Temperature | Body Temperature | 12 weeks after surgery±1 week |
| Vital Signs-Respiration | Respiration | 12 weeks after surgery±1 week |
| Vital Signs-Heart Rate | Heart Rate | 12 weeks after surgery±1 week |
| Vital Signs-Blood Pressure | Blood Pressure | 12 weeks after surgery±1 week |
| Vital Signs-Body Temperature | Body Temperature | 24 weeks after surgery±4 weeks |
| Vital Signs-Respiration | Respiration | 24 weeks after surgery±4 weeks |
| Vital Signs-Heart Rate | Heart Rate | 24 weeks after surgery±4 weeks |
| Vital Signs-Blood Pressure | Blood Pressure | 24 weeks after surgery±4 weeks |
| Vital Signs-Body Temperature | Body Temperature | 48 weeks after surgery±4 weeks |
| Vital Signs-Respiration | Respiration | 48 weeks after surgery±4 weeks |
| Vital Signs-Heart Rate | Heart Rate | 48 weeks after surgery±4 weeks |
| Vital Signs-Blood Pressure | Blood Pressure | 48 weeks after surgery±4 weeks |
| Vital Signs-Body Temperature | Body Temperature | 72 weeks after surgery± 4 weeks |
| Vital Signs-Respiration | Respiration | 72 weeks after surgery± 4 weeks |
| Vital Signs-Heart Rate | Heart Rate | 72 weeks after surgery± 4 weeks |
| Vital Signs-Blood Pressure | Blood Pressure | 72 weeks after surgery± 4 weeks |
| Laboratory Examinations-X-Ray Examination | X-Ray Examination | During the screening period |
| Laboratory Examinations-X-Ray Examination | X-Ray Examination | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-X-Ray Examination | X-Ray Examination | 6 weeks after surgery±1 week |
| Laboratory Examinations-X-Ray Examination | X-Ray Examination | 12 weeks after surgery±1 week |
| Laboratory Examinations-X-Ray Examination | X-Ray Examination | 24 weeks after surgery±4 weeks |
| Laboratory Examinations-X-Ray Examination | X-Ray Examination | 48 weeks after surgery±4 weeks |
| Laboratory Examinations-X-Ray Examination | X-Ray Examination | 72 weeks after surgery±4 weeks |
| Laboratory Examinations-Coagulation Function | Prothrombin Time (PT) | During the screening period |
| Laboratory Examinations-Coagulation Function | Activated Partial Thromboplastin Time (APTT) | During the screening period |
| Laboratory Examinations-Coagulation Function | Fibrinogen (FIB) | During the screening period |
| Laboratory Examinations-Coagulation Function | Thrombin Time (TT) | During the screening period |
| Laboratory Examinations-Coagulation Function | Prothrombin Time (PT) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Coagulation Function | Activated Partial Thromboplastin Time (APTT) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Coagulation Function | Fibrinogen (FIB) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Coagulation Function | Thrombin Time (TT) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Coagulation Function | Prothrombin Time (PT) | 24 weeks after surgery±4 weeks |
| Laboratory Examinations-Coagulation Function | Activated Partial Thromboplastin Time (APTT) | 24 weeks after surgery±4 weeks |
| Laboratory Examinations-Coagulation Function | Fibrinogen (FIB) | 24 weeks after surgery±4 weeks |
| Laboratory Examinations-Coagulation Function | Thrombin Time (TT) | 24 weeks after surgery±4 weeks |
| Laboratory Examinations-Coagulation Function | Prothrombin Time (PT) | 48 weeks after surgery±4 weeks |
| Laboratory Examinations-Coagulation Function | Activated Partial Thromboplastin Time (APTT) | 48 weeks after surgery±4 weeks |
| Laboratory Examinations-Coagulation Function | Fibrinogen (FIB) | 48 weeks after surgery±4 weeks |
| Laboratory Examinations-Coagulation Function | Thrombin Time (TT) | 48 weeks after surgery±4 weeks |
| Laboratory Examinations-Coagulation Function | Prothrombin Time (PT) | 72 weeks after surgery±4 weeks |
| Laboratory Examinations-Coagulation Function | Activated Partial Thromboplastin Time (APTT) | 72 weeks after surgery±4 weeks |
| Laboratory Examinations-Coagulation Function | Fibrinogen (FIB) | 72 weeks after surgery±4 weeks |
| Laboratory Examinations-Coagulation Function | Thrombin Time (TT) | 72 weeks after surgery±4 weeks |
| Laboratory Examinations-Routine Blood Test | Hemoglobin (Hb) | During the screening period |
| Laboratory Examinations-Routine Blood Test | Red Blood Cell Count (RBC) | During the screening period |
| Laboratory Examinations-Routine Blood Test | White Blood Cell Count (WBC) | During the screening period |
| Laboratory Examinations-Routine Blood Test | Platelet Count (PLT) | During the screening period |
| Laboratory Examinations-Routine Blood Test | Hematocrit (HCT) | During the screening period |
| Laboratory Examinations-Routine Blood Test | Hemoglobin (Hb) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Routine Blood Test | Red Blood Cell Count (RBC) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Routine Blood Test | White Blood Cell Count (WBC) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Routine Blood Test | Platelet Count (PLT) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Routine Blood Test | Hematocrit (HCT) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Routine Blood Test | Hemoglobin (Hb) | 24 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | Red Blood Cell Count (RBC) | 24 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | White Blood Cell Count (WBC) | 24 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | Platelet Count (PLT) | 24 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | Hematocrit (HCT) | 24 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | Hemoglobin (Hb) | 48 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | Red Blood Cell Count (RBC) | 48 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | White Blood Cell Count (WBC) | 48 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | Platelet Count (PLT) | 48 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | Hematocrit (HCT) | 48 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | Hemoglobin (Hb) | 72 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | Red Blood Cell Count (RBC) | 72 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | White Blood Cell Count (WBC) | 72 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | Platelet Count (PLT) | 72 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Blood Test | Hematocrit (HCT) | 72 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Urine Test | Urine Protein (PRO) | During the screening period |
| Laboratory Examinations-Routine Urine Test | Urine Red Blood Cells (RBC) | During the screening period |
| Laboratory Examinations-Routine Urine Test | Urine Glucose (GLU) | During the screening period |
| Laboratory Examinations-Routine Urine Test | Urine Protein (PRO) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Routine Urine Test | Urine Red Blood Cells (RBC) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Routine Urine Test | Urine Glucose (GLU) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Routine Urine Test | Urine Protein (PRO) | 24 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Urine Test | Urine Red Blood Cells (RBC) | 24 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Urine Test | Urine Glucose (GLU) | 24 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Urine Test | Urine Protein (PRO) | 48 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Urine Test | Urine Red Blood Cells (RBC) | 48 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Urine Test | Urine Glucose (GLU) | 48 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Urine Test | Urine Protein (PRO) | 72 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Urine Test | Urine Red Blood Cells (RBC) | 72 weeks after surgery± 4 weeks |
| Laboratory Examinations-Routine Urine Test | Urine Glucose (GLU) | 72 weeks after surgery± 4 weeks |
| Laboratory Examinations-Blood Biochemical Examination | Creatinine (Cr) | During the screening period |
| Laboratory Examinations-Blood Biochemical Examination | Urea nitrogen (BUN) | During the screening period |
| Laboratory Examinations-Blood Biochemical Examination | Urea (UREA) | During the screening period |
| Laboratory Examinations-Blood Biochemical Examination | Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) | During the screening period |
| Laboratory Examinations-Blood Biochemical Examination | Creatinine (Cr) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Blood Biochemical Examination | Urea nitrogen (BUN) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Blood Biochemical Examination | Urea (UREA) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Blood Biochemical Examination | Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) | Within 1 week after surgery (≤7 days) |
| Laboratory Examinations-Blood Biochemical Examination | Creatinine (Cr) | 24 weeks after surgery± 4 weeks |
| Laboratory Examinations-Blood Biochemical Examination | Urea nitrogen (BUN) | 24 weeks after surgery± 4 weeks |
| Laboratory Examinations-Blood Biochemical Examination | Urea (UREA) | 24 weeks after surgery± 4 weeks |
| Laboratory Examinations-Blood Biochemical Examination | Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) | 24 weeks after surgery± 4 weeks |
| Laboratory Examinations-Blood Biochemical Examination | Creatinine (Cr) | 48 weeks after surgery± 4 weeks |
| Laboratory Examinations-Blood Biochemical Examination | Urea nitrogen (BUN) | 48 weeks after surgery± 4 weeks |
| Laboratory Examinations-Blood Biochemical Examination | Urea (UREA) | 48 weeks after surgery± 4 weeks |
| Laboratory Examinations-Blood Biochemical Examination | Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) | 48 weeks after surgery± 4 weeks |
| Laboratory Examinations-Blood Biochemical Examination | Creatinine (Cr) | 72 weeks after surgery± 4 weeks |
| Laboratory Examinations-Blood Biochemical Examination | Urea nitrogen (BUN) | 72 weeks after surgery± 4 weeks |
| Laboratory Examinations-Blood Biochemical Examination | Urea (UREA) | 72 weeks after surgery± 4 weeks |
| Laboratory Examinations-Blood Biochemical Examination | Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) | 72 weeks after surgery± 4 weeks |
| Defects of Device | In the process of clinical trials, there are unreasonable risks of medical devices that may endanger human health and life safety under normal use, such as labeling errors, quality problems and malfunctions. In the course of this clinical trial, if the device fails due to the defect of the device, the investigator will carry out routine treatment according to clinical needs. Investigators should document all device discoveries that occur during the course of the clinical trial Defects. | During the screening period |
| Defects of Device | In the process of clinical trials, there are unreasonable risks of medical devices that may endanger human health and life safety under normal use, such as labeling errors, quality problems and malfunctions. In the course of this clinical trial, if the device fails due to the defect of the device, the investigator will carry out routine treatment according to clinical needs. Investigators should document all device discoveries that occur during the course of the clinical trial Defects. | Before Surgery |
| Defects of Device | In the process of clinical trials, there are unreasonable risks of medical devices that may endanger human health and life safety under normal use, such as labeling errors, quality problems and malfunctions. In the course of this clinical trial, if the device fails due to the defect of the device, the investigator will carry out routine treatment according to clinical needs. Investigators should document all device discoveries that occur during the course of the clinical trial Defects. | Within 1 week after surgery (≤7 days) |
| Defects of Device | In the process of clinical trials, there are unreasonable risks of medical devices that may endanger human health and life safety under normal use, such as labeling errors, quality problems and malfunctions. In the course of this clinical trial, if the device fails due to the defect of the device, the investigator will carry out routine treatment according to clinical needs. Investigators should document all device discoveries that occur during the course of the clinical trial Defects. | 6 weeks after surgery±1 week |
| Defects of Device | In the process of clinical trials, there are unreasonable risks of medical devices that may endanger human health and life safety under normal use, such as labeling errors, quality problems and malfunctions. In the course of this clinical trial, if the device fails due to the defect of the device, the investigator will carry out routine treatment according to clinical needs. Investigators should document all device discoveries that occur during the course of the clinical trial Defects. | 12 weeks after surgery±1 week |
| Defects of Device | In the process of clinical trials, there are unreasonable risks of medical devices that may endanger human health and life safety under normal use, such as labeling errors, quality problems and malfunctions. In the course of this clinical trial, if the device fails due to the defect of the device, the investigator will carry out routine treatment according to clinical needs. Investigators should document all device discoveries that occur during the course of the clinical trial Defects. | 24 weeks after surgery±4 weeks |
| Defects of Device | In the process of clinical trials, there are unreasonable risks of medical devices that may endanger human health and life safety under normal use, such as labeling errors, quality problems and malfunctions. In the course of this clinical trial, if the device fails due to the defect of the device, the investigator will carry out routine treatment according to clinical needs. Investigators should document all device discoveries that occur during the course of the clinical trial Defects. | 48 weeks after surgery±4 weeks |
| Defects of Device | In the process of clinical trials, there are unreasonable risks of medical devices that may endanger human health and life safety under normal use, such as labeling errors, quality problems and malfunctions. In the course of this clinical trial, if the device fails due to the defect of the device, the investigator will carry out routine treatment according to clinical needs. Investigators should document all device discoveries that occur during the course of the clinical trial Defects. | 72 weeks after surgery± 4 weeks |
| Safety Parameters-Adverse Events | During screening or follow-up, subjects were not counted as serious adverse events for anticipated or scheduled procedures. | Before Surgery |
| Safety Parameters-Adverse Events | During screening or follow-up, subjects were not counted as serious adverse events for anticipated or scheduled procedures. | Within 1 week after surgery (≤7 days) |
| Safety Parameters-Adverse Events | During screening or follow-up, subjects were not counted as serious adverse events for anticipated or scheduled procedures. | 6 weeks after surgery±1 week |
| Safety Parameters-Adverse Events | During screening or follow-up, subjects were not counted as serious adverse events for anticipated or scheduled procedures. | 12 weeks after surgery±1 week |
| Safety Parameters-Adverse Events | During screening or follow-up, subjects were not counted as serious adverse events for anticipated or scheduled procedures. | 24 weeks after surgery±4 weeks |
| Safety Parameters-Adverse Events | During screening or follow-up, subjects were not counted as serious adverse events for anticipated or scheduled procedures. | 48 weeks after surgery±4 weeks |
| Safety Parameters-Adverse Events | During screening or follow-up, subjects were not counted as serious adverse events for anticipated or scheduled procedures. | 72 weeks after surgery± 4 weeks |
| Drug Combination | The relevant drugs other than glucose, normal saline and narcotic drugs used during the trial were recorded. | During the screening period |
| Drug Combination | The relevant drugs other than glucose, normal saline and narcotic drugs used during the trial were recorded. | Before Surgery |
| Drug Combination | The relevant drugs other than glucose, normal saline and narcotic drugs used during the trial were recorded. | Within 1 week after surgery (≤7 days) |
| Drug Combination | The relevant drugs other than glucose, normal saline and narcotic drugs used during the trial were recorded. | 6 weeks after surgery±1 week |
| Drug Combination | The relevant drugs other than glucose, normal saline and narcotic drugs used during the trial were recorded. | 12 weeks after surgery±1 week |
| Drug Combination | The relevant drugs other than glucose, normal saline and narcotic drugs used during the trial were recorded. | 24 weeks after surgery±4 weeks |
| Drug Combination | The relevant drugs other than glucose, normal saline and narcotic drugs used during the trial were recorded. | 48 weeks after surgery±4 weeks |
| Drug Combination | The relevant drugs other than glucose, normal saline and narcotic drugs used during the trial were recorded. | 72 weeks after surgery±4 weeks |