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New dissolving metal nail could change how broken bones are fixed
NCT ID NCT07569575
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tests a new type of nail made from magnesium and titanium to fix broken leg or arm bones. The nail is designed to provide strong support while part of it gradually dissolves over time. Researchers will compare it to standard metal nails in 160 adults to see if it is just as safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Magnesium-titanium hybrid intramedullary nail system
- What this could lead to
- If it works, this could offer a new option for fixing broken bones that may gradually dissolve over time, potentially reducing the need for a second surgery to remove hardware.
- What could go wrong
- This is an early-stage trial with only 160 participants, so results may not apply to everyone. The new nail could fail to heal the fracture properly or cause unexpected side effects like inflammation or breakage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged ≥ 18 years and ≤ 80 years (inclusive), with skeletal maturity, regardless of gender; 2. Diagnosed with long bone fractures of the extremities (including femur, tibia, humerus) requiring surgical fixation with intramedullary nail; 3. Good treatment compliance, willing and able to complete follow-up and observation as required; 4. Voluntarily participate in this trial and sign the written informed consent form. Exclusion Criteria: 1. Pregnant or lactating women, or individuals with family planning during the study period; 2. Pathological fractures (e.g., bone tumor, bone metastasis, osteomalacia), or patients with too narrow or occluded medullary cavity; 3. Patients complicated with osteomyelitis, osteofascial compartment syndrome, systemic infection or local infection at the surgical site; 4. Patients with severe bone defects requiring artificial bone or autologous bone grafting; 5. Patients with severe soft tissue or vascular injury, or previous surgical treatment at the fracture site, where intramedullary nailing may not provide stable fixation; 6. Patients without sufficient soft tissue coverage at the proposed surgical site; 7. Patients diagnosed with severe osteoporosis by the investigator based on medical history and X-ray films of the fracture site; 8. Patients requiring simultaneous use of both intramedullary nail and screw-plate system at the planned surgical site; 9. Patients with hypermagnesemia (serum magnesium \> 1.25 mmol/L (3.0 mg/dL)); 10. Patients with uncontrolled diabetes mellitus (glycated hemoglobin HbA1c ≥ 8.0%); 11. Patients with severe cardiovascular, hepatic, renal, pulmonary, hematological diseases or metabolic disorders who cannot tolerate surgery; 12. 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); 13. 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; 14. Patients with constitutions allergic to the implanted materials or known allergies; 15. Patients who have participated or are participating in any drug clinical trials within 3 months, or other medical device clinical trials within 30 days; 16. Other conditions where the investigator determines the patient is unsuitable for inclusion (e.g., metabolic bone disease, poliomyelitis sequelae, etc.).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Jishuitan Hospital, Capital Medical University
Xicheng, Beijing Municipality, China
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Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China
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Henan Luoyang Orthopedic Hospital (Henan Orthopedic Hospital)
Luoyang, He'Nan, China
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Xuhui, Shanghai Municipality, China
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Xi'an Honghui Hospital
Xi'an, Shaanxi, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Step-by-Step rehab plan speed leg recovery after a broken shinbone?
- A surgical showdown for teen shinbone fractures: which fix heals faster?
- New surgical approach may offer safer fix for broken arm
- Simple drug may cut bleeding in broken leg surgery
- New metal rod shows promise for healing broken thighs
- Can a simple supplement speed up fracture recovery in seniors?