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.
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.
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.
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
Xi'an, Shaanxi, China
Cinical Fracture Healing Rate
1. No local tenderness or longitudinal percussion pain, no local abnormal activity; 2. 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. 3. Healing rate = (Healing cases / Total cases) ×100%
Time frame: 24 weeks after surgery+4 weeks
Cinical Fracture Healing Rate
1. No local tenderness or longitudinal percussion pain, no local abnormal activity; 2. 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. 3. Healing rate = (Healing cases / Total cases) ×100%
Time frame: 12 weeks after surgery±1 week
Cinical Fracture Healing Rate
1. No local tenderness or longitudinal percussion pain, no local abnormal activity; 2. 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. 3. Healing rate = (Healing cases / Total cases) ×100%
Time frame: 48 weeks after surgery± 4 weeks
Cinical Fracture Healing Rate
1. No local tenderness or longitudinal percussion pain, no local abnormal activity; 2. 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. 3. Healing rate = (Healing cases / Total cases) ×100%
Time frame: 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.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 72 weeks after surgery± 4 weeks