A Clinical Study to Evaluate the Safety and Efficacy of Biologic Hollow Bone Screws

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.

Study Overview

• Status: Suspended
• Conditions: Fracture Fixation, Internal
• Intervention / Treatment: Device: Active Comparator: Fracture Fixation (Inion Freedom Screws); Device: Experimental: Fracture Fixation (Biological Hollow Bone Screws)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

1. Aged 18-75 years old (inclusive), both sexes;
2. Patients with knee and ankle fractures requiring internal fixation confirmed by imaging examination;
3. Voluntary participation in the clinical trial and signing of the informed consent.

Exclusion criteria

1. The following conditions exist at the fracture site: infection, osteofascial compartment syndrome, osteitis, pathological fracture, open fracture, severe tissue or vascular and nerve injury, or insufficient bone mass of the affected limb affecting screw implantation, etc.
2. Abnormal liver and kidney function with clinical significance (ALT, AST 2 times the upper limit of normal value and Cr 2 times the upper limit of normal value);
3. Abnormal coagulation function with clinical significance (APTT > 2 times the upper limit of normal value);
4. Patients with difficult-to-control diabetes (any blood glucose > 11.1mmol/L or glycosylated hemoglobin > 9%);
5. Past allergies to silk protein materials;
6. Mental illness;
7. Patients who cannot guarantee to quit smoking during the fracture healing period;
8. Pregnant or lactating women or women of childbearing age who plan to get pregnant within 6 months;
9. Those who have participated in other pre-clinical trials within 1 month before the trial;
10. Those who are considered inappropriate to participate in the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inion Freedom Screws; Patients were treated with screws developed by Inion Oy, Finland for the fixation of fractures in the knee and ankle joints.	Device: Active Comparator: Fracture Fixation (Inion Freedom Screws); 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.
Experimental: Biologic Hollow Bone Screws; Patients were treated with screws developed by Jiangxi Sike Biotechnology, China for the fixation of fractures in the knee and ankle joints.	Device: Experimental: Fracture Fixation (Biological Hollow Bone Screws); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cinical Fracture Healing Rate	No local tenderness or longitudinal percussion pain, no local abnormal activity;; X-rays show a continuous bone scab or trabeculae crossing the fracture line at the fracture site and the fracture line has been blurred. If both of these are met, the fracture is considered healed, and vice versa.; Healing rate = (Healing cases / Total cases) ×100%	24 weeks after surgery+4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cinical Fracture Healing Rate	No local tenderness or longitudinal percussion pain, no local abnormal activity;; X-rays show a continuous bone scab or trabeculae crossing the fracture line at the fracture site and the fracture line has been blurred. If both of these are met, the fracture is considered healed, and vice versa.; Healing rate = (Healing cases / Total cases) ×100%	12 weeks after surgery±1 week
Cinical Fracture Healing Rate	No local tenderness or longitudinal percussion pain, no local abnormal activity;; X-rays show a continuous bone scab or trabeculae crossing the fracture line at the fracture site and the fracture line has been blurred. If both of these are met, the fracture is considered healed, and vice versa.; Healing rate = (Healing cases / Total cases) ×100%	48 weeks after surgery± 4 weeks
Cinical Fracture Healing Rate	No local tenderness or longitudinal percussion pain, no local abnormal activity;; X-rays show a continuous bone scab or trabeculae crossing the fracture line at the fracture site and the fracture line has been blurred. If both of these are met, the fracture is considered healed, and vice versa.; Healing rate = (Healing cases / Total cases) ×100%	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: FengYafei

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: April 28, 2024
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Prognosis; Fracture fixation; Silk fibroin bone screws; Knee and ankle joints; Safety and efficacy evaluation
• Other Study ID Numbers: QX20221007-X-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No