Tibial FractureNCT07569575
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
A study testing Magnesium-Titanium Hybrid Intramedullary Nail System and Commercially Locked Metallic Intramedullary Nail in people with Tibial Fracture and Femoral Fracture, run by HuaMg Perfection Med Tech (Suzhou) Co., Ltd. at 5 sites in China.
Trial summary
This is a prospective, multicenter, randomized, controlled, non-inferiority clinical trial designed to evaluate the safety and effectiveness of the magnesium-titanium hybrid intramedullary nail system compared with the marketed metal locked intramedullary nail in the treatment of long bone fractures of the extremities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tibial Fracture, Femoral Fracture, Humeral Fracture
- What is being tested?
- Magnesium-Titanium Hybrid Intramedullary Nail System and Commercially Locked Metallic Intramedullary Nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 5 sitesChina
- Study dates
- 1 Nov 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years and ≤ 80 years (inclusive), with skeletal maturity, regardless of gender;
- Diagnosed with long bone fractures of the extremities (including femur, tibia, humerus) requiring surgical fixation with intramedullary nail;
- Good treatment compliance, willing and able to complete follow-up and observation as required;
- Voluntarily participate in this trial and sign the written informed consent form.
Who cannot join
- Pregnant or lactating women, or individuals with family planning during the study period;
- Pathological fractures (e.g., bone tumor, bone metastasis, osteomalacia), or patients with too narrow or occluded medullary cavity;
- Patients complicated with osteomyelitis, osteofascial compartment syndrome, systemic infection or local infection at the surgical site;
- Patients with severe bone defects requiring artificial bone or autologous bone grafting;
- Patients with severe soft tissue or vascular injury, or previous surgical treatment at the fracture site, where intramedullary nailing may not provide stable fixation;
- Patients without sufficient soft tissue coverage at the proposed surgical site;
Show all 16Show fewer
- Patients diagnosed with severe osteoporosis by the investigator based on medical history and X-ray films of the fracture site;
- Patients requiring simultaneous use of both intramedullary nail and screw-plate system at the planned surgical site;
- Patients with hypermagnesemia (serum magnesium > 1.25 mmol/L (3.0 mg/dL));
- Patients with uncontrolled diabetes mellitus (glycated hemoglobin HbA1c ≥ 8.0%);
- Patients with severe cardiovascular, hepatic, renal, pulmonary, hematological diseases or metabolic disorders who cannot tolerate surgery;
- Patients with previous or concurrent malignant tumors (excluding those cured and disease-free survival for more than 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma);
- Patients who have received radiotherapy, chemotherapy, growth factors, immunosuppressants, systemic corticosteroids, long-term (continuous use for more than 3 months) sedative-hypnotics, non-steroidal anti-inflammatory drugs, or bisphosphonates within 6 months prior to screening;
- Patients with constitutions allergic to the implanted materials or known allergies;
- Patients who have participated or are participating in any drug clinical trials within 3 months, or other medical device clinical trials within 30 days;
- Other conditions where the investigator determines the patient is unsuitable for inclusion (e.g., metabolic bone disease, poliomyelitis sequelae, etc.).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Henan Luoyang Orthopedic Hospital (Henan Orthopedic Hospital)
Luoyang, He'Nan
Yunlong Liu, MD, +86 18037786581, liuyunlongboa@163.com
Yanchun Shang, PhD
Hebei Medical University Third Hospital
Shijiazhuang, Hebei
Kuo Zhao, MD, +86 18033832759, surgeonchenwei@126.com
Wei Chen, PhD
Xi'an Honghui Hospital
Xi'an, Shaanxi
Pengfei Wang, MD, +86 13759994007, pengfei_wang@163.com
Kun Zhang, PhD
Beijing Jishuitan Hospital, Capital Medical University
Xicheng, Beijing Municipality
Maoqi Gong, PhD, +86 10 58517080, jst2603@126.com
Xieyuan Jiang, PhD
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Xuhui, Shanghai Municipality
Hongyi Zhu, PhD, +86 021 64369181, 420308955@qq.com
Changqing Zhang, PhD
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial to Evaluate the Safety and Effectiveness of the Magnesium-titanium Hybrid Intramedullary Nail System in Treating Long Bone Fractures of the Extremities
This is a prospective, multicenter, randomized, controlled, non-inferiority clinical trial designed to evaluate the safety and effectiveness of the magnesium-titanium hybrid intramedullary nail system compared with the marketed metal locked intramedullary nail in the treatment of long bone fractures of the extremities.
Read the detailed description
Intramedullary nailing, a common surgical procedure to fix broken long bones, has a long history. As early as the 16th century, anthropologist Bernardino documented that local physicians in Mexico used wooden rods inserted into the bone marrow cavity to treat patients with unhealed long bone fractures. Modern metallic intramedullary nails were widely adopted after 1939, when Dr. KÜNTSCHER successfully treated femoral shaft fractures with V-shaped stainless steel nails. This technique was introduced to China in the early 1950s, and has since become the first-line treatment for fractures of the arm and leg bones, especially with the advancement of minimally invasive and biological fixation principles.
Traditional intramedullary nails rely on tight contact with the bone marrow cavity for stability. The later development of interlocking screws further improved stability, expanded clinical applications, and reduced complications. Compared with other fixation methods, intramedullary nails offer multiple advantages: they are inserted through small incisions to protect surrounding soft tissues, reduce infection risk, distribute stress evenly to avoid bone weakening, and allow early postoperative movement and weight-bearing, which speeds up recovery.
Currently, biodegradable magnesium and magnesium-based materials are a major global focus in orthopedic implant research. Magnesium is a naturally occurring metal that the body can absorb safely. It has excellent biocompatibility and mechanical properties very similar to human bone, making it an ideal revolutionary implant material. Growing evidence shows that magnesium ions released during the gradual degradation of magnesium implants can actively promote new bone growth and blood vessel formation, which is highly beneficial for fracture healing.
HuaMg Perfection Med Tech (Suzhou) Co., Ltd. has developed high-purity magnesium for orthopedic fixation implants. In preclinical animal studies conducted by qualified third-party institutions, a goat tibial fracture model experiment compared the company's magnesium-titanium hybrid intramedullary nail (experimental group) with conventional titanium alloy intramedullary nails (control group). The results demonstrated that the magnesium-titanium hybrid nail significantly promoted faster and more effective fracture healing than traditional titanium alloy nails.
Based on these promising preclinical findings, this prospective, multicenter, randomized controlled clinical trial is designed to evaluate the safety and effectiveness of the magnesium-titanium hybrid intramedullary nail system for treating long bone fractures of the extremities, compared with the commercially available locked metallic intramedullary nail.
- Conditions
- Tibial Fracture, Femoral Fracture, Humeral Fracture
- Being tested
- Magnesium-Titanium Hybrid Intramedullary Nail System, Commercially Locked Metallic Intramedullary Nail
- Keywords
- Magnesium-Titanium Hybrid Intramedullary Nail, Long Bone Fractures of the Extremities, Intramedullary Nailing, Biodegradable Magnesium Implant
- Medical subject headings
- Tibial Fractures, Femoral Fractures, Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium-Titanium Hybrid Intramedullary Nail SystemDevice
The magnesium-titanium hybrid intramedullary nail system is inserted into the medullary canal through the proximal or distal end of the bone via standard intramedullary fixation surgical procedures, achieving fixation of the fracture site through intramedullary stabilization. This device provides load-sharing fixation for the fracture. The titanium alloy main body of the product delivers continuous, reliable mechanical support to ensure the overall stability of fracture fixation. The biodegradable magnesium components gradually degrade in vivo, releasing magnesium ions that participate in regulating the local bone repair microenvironment, thereby synergistically supporting the fracture healing process.
Commercially Locked Metallic Intramedullary NailDevice
Commercially available metallic intramedullary nails including the humeral intramedullary nail (NMPA Registration No. 20233130578) and locked intramedullary nail (NMPA Registration No. 20163131478) manufactured by Shandong Weigao Orthopaedic Device Co., Ltd. are selected as the control devices based on the following reasons: 1) Shandong Weigao Orthopaedic Device Co., Ltd. is a leading orthopaedic enterprise in China, and its products are widely used in clinical practice with well-established efficacy and safety profiles; 2) The indications of the control devices fully cover those of the investigational device.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium-Titanium Hybrid Intramedullary Nail System | Experimental | Indicated for intramedullary fixation and fracture healing promotion in humeral, femoral, and tibial diaphyseal, proximal, and distal extremity fractures during orthopedic surgery. Receives: Device: Magnesium-Titanium Hybrid Intramedullary Nail System |
| Commercially Locked Metallic Intramedullary Nail | Active comparator | Indicated for internal fixation of long bone fractures of the extremities. Receives: Device: Commercially Locked Metallic Intramedullary Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective rate of the product at 180 days postoperatively
"Product effectiveness" is defined as the simultaneous fulfillment of the following criteria: (a) Fracture healing assessment criteria: no local tenderness or longitudinal percussion pain, no abnormal local movement; on radiographs of the fracture site, the fracture line is obscured or obliterated, or continuous callus or trabecular bone crossing the fracture line is visible. (b) No deformation, loosening, or breakage of the implanted product.
Calculation formula: Product effectiveness rate at 180 days postoperatively = (Number of cases with effective product at 180 days postoperatively ÷ Total number of cases in the group) × 100%
Measured: 180±14 days postoperatively
Secondary outcomes (7)
Fracture healing status
Fracture healing status will be documented at various follow-up time points after surgical reduction and internal fixation, and the fracture healing rate will be calculated. Fracture healing assessment criteria: No local tenderness or longitudinal percussion pain, and no abnormal local mobility; On radiographs of the fracture site, the fracture line is obscured or obliterated, or continuous callus or trabecular bone crossing the fracture line is visible.
Calculation formula: Fracture healing rate = (Number of cases with fracture healing ÷ Total number of cases in the group) × 100%
Measured: 42±7 days, 90±7 days, and 180±14 days postoperatively
Surgical duration
The duration from the start of skin incision to the completion of wound closure and suture.
Calculation method: The mean operative time will be calculated separately for the investigational group and the control group.
Measured: Intraoperative
Intraoperative estimated blood loss
The estimated intraoperative blood loss (mL) will be recorded, based on the official operative record.
Measured: Intraoperative
Evaluation of Device Operability
Device operability will be evaluated according to the following criteria, and the excellent-good rate will be calculated.
Evaluation Criteria:
Excellent: Complete configuration, simple operation, strong operability, and excellent compatibility of all components; Good: Complete configuration, acceptable operation, acceptable operability, and acceptable compatibility of all components; Fair: Average configuration, average operation, average operability, and average compatibility of all components; Poor: Incomplete configuration, cumbersome operation, poor operability, and poor compatibility of all components.
Calculation Formula:
Device Operability Excellent-Good Rate = (Number of cases rated Excellent or Good) ÷ (Total number of cases in the group) × 100%
Measured: Day of Surgery
Occurrence of Adverse Events
Definition: Includes the incidence rate (%) and number of events for (serious) adverse events, as well as the incidence rate (%) and number of events for device-related (serious) adverse events.
Adverse events include, but are not limited to, deformation, breakage, and loosening of the intramedullary nail and locking components, as well as infection, compartment syndrome, nerve injury, non-union, delayed union, and other complications.
Measured: Through study completion, with an average follow-up duration of 180 days (range: 166-194 days postoperatively)
Laboratory Examinations
Routine blood tests (RBC, WBC, HGB, PLT), electrolyte tests (Ca²⁺, Mg²⁺), routine urine tests (RBC, PRO, WBC), and blood biochemistry tests (ALT, AST, TBIL, BUN/UREA, Cr) will be performed, and the laboratory findings of the experimental group and control group will be recorded.
Measured: Within 7 days after surgery, 42±7 days postoperatively (electrolytes only), 90±7 days postoperatively (electrolytes only), 180±14 days postoperatively (electrolytes only)
Occurrence of Device Deficiencies
Investigators will observe and record any device deficiencies that occur with the medical device under normal use during the clinical trial, including labeling errors, quality issues, malfunctions, etc. The incidence rate (%) and number of device deficiency events will be calculated.
Measured: Through study completion, with an average follow-up duration of 180 days (range: 166-194 days postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FractureStudies 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
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HuaMg Perfection Med Tech (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ling Qin, PhD, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569575
- Sponsor's protocol ID
- HM-CT-MgIMN-001
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial to Evaluate the Safety and Effectiveness of the Magnesium-titanium Hybrid Intramedullary Nail System in Treating Long Bone Fractures of the Extremities
- ClinicalTrials.gov ID
- NCT07569575
- Acronym / sponsor ID
- HM-CT-MgIMN-001
- Conditions
- Tibial Fracture, Femoral Fracture, Humeral Fracture
- Keywords
- Magnesium-Titanium Hybrid Intramedullary Nail, Long Bone Fractures of the Extremities, Intramedullary Nailing, Biodegradable Magnesium Implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- HuaMg Perfection Med Tech (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 May 2026 (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.
This is a prospective, multicenter, randomized, controlled, non-inferiority clinical trial designed to evaluate the safety and effectiveness of the magnesium-titanium hybrid intramedullary nail system compared with the marketed metal locked intramedullary nail in the treatment of long bone fractures of the extremities.
Detailed description
Intramedullary nailing, a common surgical procedure to fix broken long bones, has a long history. As early as the 16th century, anthropologist Bernardino documented that local physicians in Mexico used wooden rods inserted into the bone marrow cavity to treat patients with unhealed long bone fractures. Modern metallic intramedullary nails were widely adopted after 1939, when Dr. KÜNTSCHER successfully treated femoral shaft fractures with V-shaped stainless steel nails. This technique was introduced to China in the early 1950s, and has since become the first-line treatment for fractures of the arm and leg bones, especially with the advancement of minimally invasive and biological fixation principles.
Traditional intramedullary nails rely on tight contact with the bone marrow cavity for stability. The later development of interlocking screws further improved stability, expanded clinical applications, and reduced complications. Compared with other fixation methods, intramedullary nails offer multiple advantages: they are inserted through small incisions to protect surrounding soft tissues, reduce infection risk, distribute stress evenly to avoid bone weakening, and allow early postoperative movement and weight-bearing, which speeds up recovery.
Currently, biodegradable magnesium and magnesium-based materials are a major global focus in orthopedic implant research. Magnesium is a naturally occurring metal that the body can absorb safely. It has excellent biocompatibility and mechanical properties very similar to human bone, making it an ideal revolutionary implant material. Growing evidence shows that magnesium ions released during the gradual degradation of magnesium implants can actively promote new bone growth and blood vessel formation, which is highly beneficial for fracture healing.
HuaMg Perfection Med Tech (Suzhou) Co., Ltd. has developed high-purity magnesium for orthopedic fixation implants. In preclinical animal studies conducted by qualified third-party institutions, a goat tibial fracture model experiment compared the company's magnesium-titanium hybrid intramedullary nail (experimental group) with conventional titanium alloy intramedullary nails (control group). The results demonstrated that the magnesium-titanium hybrid nail significantly promoted faster and more effective fracture healing than traditional titanium alloy nails.
Based on these promising preclinical findings, this prospective, multicenter, randomized controlled clinical trial is designed to evaluate the safety and effectiveness of the magnesium-titanium hybrid intramedullary nail system for treating long bone fractures of the extremities, compared with the commercially available locked metallic intramedullary nail.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium-Titanium Hybrid Intramedullary Nail System | Experimental | Device: Magnesium-Titanium Hybrid Intramedullary Nail SystemIndicated for intramedullary fixation and fracture healing promotion in humeral, femoral, and tibial diaphyseal, proximal, and distal extremity fractures during orthopedic surgery. |
| Commercially Locked Metallic Intramedullary Nail | Active comparator | Device: Commercially Locked Metallic Intramedullary NailIndicated for internal fixation of long bone fractures of the extremities. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥ 18 years and ≤ 80 years (inclusive), with skeletal maturity, regardless of gender;
- Diagnosed with long bone fractures of the extremities (including femur, tibia, humerus) requiring surgical fixation with intramedullary nail;
- Good treatment compliance, willing and able to complete follow-up and observation as required;
- Voluntarily participate in this trial and sign the written informed consent form.
Key exclusion criteria (16 listed)
- Pregnant or lactating women, or individuals with family planning during the study period;
- Pathological fractures (e.g., bone tumor, bone metastasis, osteomalacia), or patients with too narrow or occluded medullary cavity;
- Patients complicated with osteomyelitis, osteofascial compartment syndrome, systemic infection or local infection at the surgical site;
- Patients with severe bone defects requiring artificial bone or autologous bone grafting;
- Patients with severe soft tissue or vascular injury, or previous surgical treatment at the fracture site, where intramedullary nailing may not provide stable fixation;
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 |
|---|---|---|
| Magnesium-Titanium Hybrid Intramedullary Nail SystemThe magnesium-titanium hybrid intramedullary nail system is inserted into the medullary canal through the proximal or distal end of the bone via standard intramedullary fixation surgical procedures, achieving fixation of the fracture site through intramedullary stabilization. This device provides load-sharing fixation for the fracture. The titanium alloy main body of the product delivers continuous, reliable mechanical support to ensure the overall stability of fracture fixation. The biodegradable magnesium components gradually degrade in vivo, releasing magnesium ions that participate in regulating the local bone repair microenvironment, thereby synergistically supporting the fracture healing process. | Device | Magnesium-Titanium Hybrid Intramedullary Nail System |
| Commercially Locked Metallic Intramedullary NailCommercially available metallic intramedullary nails including the humeral intramedullary nail (NMPA Registration No. 20233130578) and locked intramedullary nail (NMPA Registration No. 20163131478) manufactured by Shandong Weigao Orthopaedic Device Co., Ltd. are selected as the control devices based on the following reasons: 1) Shandong Weigao Orthopaedic Device Co., Ltd. is a leading orthopaedic enterprise in China, and its products are widely used in clinical practice with well-established efficacy and safety profiles; 2) The indications of the control devices fully cover those of the investigational device. | Device | Commercially Locked Metallic Intramedullary Nail |
Primary outcome
Effective rate of the product at 180 days postoperatively
Time frame: 180±14 days postoperatively
"Product effectiveness" is defined as the simultaneous fulfillment of the following criteria: (a) Fracture healing assessment criteria: no local tenderness or longitudinal percussion pain, no abnormal local movement; on radiographs of the fracture site, the fracture line is obscured or obliterated, or continuous callus or trabecular bone crossing the fracture line is visible. (b) No deformation, loosening, or breakage of the implanted product. Calculation formula: Product effectiveness rate at 180 days postoperatively = (Number of cases with effective product at 180 days postoperatively ÷ Total number of cases in the group) × 100%
7 secondary outcomes
Fracture healing status
Time frame: 42±7 days, 90±7 days, and 180±14 days postoperatively
Surgical duration
Time frame: Intraoperative
Intraoperative estimated blood loss
Time frame: Intraoperative
Evaluation of Device Operability
Time frame: Day of Surgery
Occurrence of Adverse Events
Time frame: Through study completion, with an average follow-up duration of 180 days (range: 166-194 days postoperatively)
Laboratory Examinations
Time frame: Within 7 days after surgery, 42±7 days postoperatively (electrolytes only), 90±7 days postoperatively (electrolytes only), 180±14 days postoperatively (electrolytes only)
Occurrence of Device Deficiencies
Time frame: Through study completion, with an average follow-up duration of 180 days (range: 166-194 days postoperatively)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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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.
Ling Qin, PhD study director
Chinese University of Hong Kong
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium-Titanium Hybrid Intramedullary Nail System and Commercially Locked Metallic Intramedullary Nail in people with Tibial Fracture and Femoral Fracture, run by HuaMg Perfection Med Tech (Suzhou) Co., Ltd. at 5 sites 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 4 inclusion and 16 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuantao Zhang, PhD (+86 13421870043, ytzhang2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective rate of the product at 180 days postoperatively (time frame: 180±14 days postoperatively). 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 3 Nov 2026.