Fracture Fixation, InternalNCT06942247
A Clinical Study to Evaluate the Safety and Efficacy of Biologic Hollow Bone Screws
A study testing Active Comparator: Fracture Fixation (Inion Freedom Screws) and Experimental: Fracture Fixation (Biological Hollow Bone Screws) in people with Fracture Fixation, Internal, run by FengYafei at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fracture Fixation, Internal
- What is being tested?
- Active Comparator: Fracture Fixation (Inion Freedom Screws) and Experimental: Fracture Fixation (Biological Hollow Bone Screws)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years old (inclusive), both sexes;
- Patients with knee and ankle fractures requiring internal fixation confirmed by imaging examination;
- Voluntary participation in the clinical trial and signing of the informed consent.
Who cannot join
- 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.
- 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);
- Abnormal coagulation function with clinical significance (APTT > 2 times the upper limit of normal value);
- Patients with difficult-to-control diabetes (any blood glucose > 11.1mmol/L or glycosylated hemoglobin > 9%);
- Past allergies to silk protein materials;
- Mental illness;
Show all 10Show fewer
- Patients who cannot guarantee to quit smoking during the fracture healing period;
- Pregnant or lactating women or women of childbearing age who plan to get pregnant within 6 months;
- Those who have participated in other pre-clinical trials within 1 month before the trial;
- Those who are considered inappropriate to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
Xi'an, Shaanxi, 710032
About this study
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.
Read the 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.
- Conditions
- Fracture Fixation, Internal
- Being tested
- Active Comparator: Fracture Fixation (Inion Freedom Screws), Experimental: Fracture Fixation (Biological Hollow Bone Screws)
- Keywords
- Silk fibroin bone screws, Fracture fixation, Knee and ankle joints, Safety and efficacy evaluation, Prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Active Comparator: Fracture Fixation (Inion Freedom Screws) |
| 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. Receives: Device: Experimental: Fracture Fixation (Biological Hollow Bone Screws) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 24 weeks after surgery+4 weeks
Secondary outcomes (20)
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%
Measured: 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%
Measured: 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%
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 72 weeks after surgery± 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: 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."
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture Fixation, InternalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- FengYafei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, FengYafei, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942247
- Sponsor's protocol ID
- QX20221007-X-1
- Status last verified
- Aug 2025
- First submitted
- 28 Apr 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of Biologic Hollow Bone Screws
- ClinicalTrials.gov ID
- NCT06942247
- Acronym / sponsor ID
- QX20221007-X-1
- Conditions
- Fracture Fixation, Internal
- Keywords
- Silk fibroin bone screws, Fracture fixation, Knee and ankle joints, Safety and efficacy evaluation, Prognosis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: 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."
- Enrolment
- 160 participants (actual)
- Lead sponsor
- FengYafeiUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Inion Freedom Screws | Active comparator | Device: Active Comparator: Fracture Fixation (Inion Freedom Screws)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 | Device: Experimental: Fracture Fixation (Biological 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-75 years old (inclusive), both sexes;
- Patients with knee and ankle fractures requiring internal fixation confirmed by imaging examination;
- Voluntary participation in the clinical trial and signing of the informed consent.
Key exclusion criteria (10 listed)
- 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.
- 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);
- Abnormal coagulation function with clinical significance (APTT > 2 times the upper limit of normal value);
- Patients with difficult-to-control diabetes (any blood glucose > 11.1mmol/L or glycosylated hemoglobin > 9%);
- Past allergies to silk protein materials;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Inion Freedom Screws |
| 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. | Device | Biologic Hollow Bone Screws |
Primary outcome
Cinical Fracture Healing Rate
Time frame: 24 weeks after surgery+4 weeks
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%
20 secondary outcomes
Cinical Fracture Healing Rate
Time frame: 12 weeks after surgery±1 week
Cinical Fracture Healing Rate
Time frame: 48 weeks after surgery± 4 weeks
Cinical Fracture Healing Rate
Time frame: 72 weeks after surgery± 4 weeks
Visual Analogue Scale (VAS)
Time frame: During the screening period
Visual Analogue Scale (VAS)
Time frame: Within 1 week after surgery (≤7 days)
Visual Analogue Scale (VAS)
Time frame: 6 weeks after surgery±1 week
Visual Analogue Scale (VAS)
Time frame: 12 weeks after surgery±1 week
Visual Analogue Scale (VAS)
Time frame: 24 weeks after surgery±4 weeks
Visual Analogue Scale (VAS)
Time frame: 48 weeks after surgery±4 weeks
Visual Analogue Scale (VAS)
Time frame: 72 weeks after surgery± 4 weeks
The American Knee Society (AKS) Clinical Rating System
Time frame: 6 weeks after surgery±1 week
The American Knee Society (AKS) Clinical Rating System
Time frame: 12 weeks after surgery±1 week
The American Knee Society (AKS) Clinical Rating System
Time frame: 24 weeks after surgery±4 weeks
The American Knee Society (AKS) Clinical Rating System
Time frame: 48 weeks after surgery±4 weeks
The American Knee Society (AKS) Clinical Rating System
Time frame: 72 weeks after surgery± 4 weeks
Mazur Ankle Joint Functional Evaluation
Time frame: 6 weeks after surgery±1 week
Mazur Ankle Joint Functional Evaluation
Time frame: 12 weeks after surgery±1 week
Mazur Ankle Joint Functional Evaluation
Time frame: 24 weeks after surgery±4 weeks
Mazur Ankle Joint Functional Evaluation
Time frame: 48 weeks after surgery±4 weeks
Mazur Ankle Joint Functional Evaluation
Time frame: 72 weeks after surgery± 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
Related trials for Fracture Fixation, Internal
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Recruiting
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
Mandibular Fractures
Not yet recruiting
MALMOS Technique for Selected Subaxial Cervical Spine Fractures
Cervical Spine Fractures
RecruitingObservational study
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
Syndesmotic Injury, Trimalleolar Fracture
RecruitingPhase 4
Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
Opioid Use, Fractures, Bone
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Fracture Fixation (Inion Freedom Screws) and Experimental: Fracture Fixation (Biological Hollow Bone Screws) in people with Fracture Fixation, Internal, run by FengYafei at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cinical Fracture Healing Rate (time frame: 24 weeks after surgery+4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.