Comparing a new 3D-printed leg brace with standard surgery for treating shin bone fractures

Clinical efficacy of digital intelligence-based 3D-printed reduction braces in the treatment of tibiofibular fractures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10781625

Enrollment

Registered

2026-05-28

Start date

2025-09-01

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibiofibular fractures (closed tibial shaft fractures) Musculoskeletal Diseases

Interventions

Participants were randomly assigned to either the intervention group or the control group. The intervention group received treatment utilizing a patient-specific, digital intelligence-based, 3D-print

Eligibility

Sex/Gender

All

Age

12 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age between 12 and 65 years, irrespective of gender 2. AO/OTA 42 type tibial shaft fractures, with or without associated fibular fractures (4F2) 3. Absence of other concomitant injuries or congenital diseases that could interfere with fracture healing 4. Signed informed consent and the ability to cooperate fully with the entire treatment process and subsequent follow-up

Exclusion criteria

Exclusion criteria: 1. Open, neglected, or pathological fractures 2. Bilateral tibiofibular fractures 3. Pregnant or lactating women 4. Patients with severe cardiovascular disease, hepatic or renal dysfunction, severe coagulopathy, or other critical illnesses that preclude surgical tolerance 5. Patients with major psychiatric disorders

Countries

China

Contacts

Public ContactXiaohui Teng

17596534816@163.com+86 17596534816

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026