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New dissolving metal nail could change how broken bones are fixed

NCT ID NCT07569575

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Jishuitan Hospital, Capital Medical University

    Xicheng, Beijing Municipality, China

  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei, China

  • Henan Luoyang Orthopedic Hospital (Henan Orthopedic Hospital)

    Luoyang, He'Nan, China

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    Xuhui, Shanghai Municipality, China

  • Xi'an Honghui Hospital

    Xi'an, Shaanxi, China

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