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

ISRCTN	ISRCTN10781625
DOI	https://doi.org/10.1186/ISRCTN10781625
Sponsor	Luoyang Orthopedic Hospital of Henan Province (Henan Provincial Orthopedic Hospital)
Funder	Luoyang Orthopedic Hospital of Henan Province (Henan Provincial Orthopedic Hospital)

Submission date: 21/05/2026
Registration date: 28/05/2026
Last edited: 21/05/2026

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Xiaohui Teng
Principal investigator, Scientific, Public

Luoyang Orthopedic Hospital of Henan Province (Henan Provincial Orthopedic Hospital),No. 82 Qiming South Road
Luoyang
471000
China

Phone	+86 17596534816
Email	17596534816@163.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Clinical efficacy of digital intelligence-based 3D-printed reduction braces in the treatment of tibiofibular fractures
Study objectives
Ethics approval(s)	Approved 09/05/2026, Ethics Committee of Henan Luoyang Orthopedic Hospital (Henan Provincial Orthopedic Hospital) (Luoyang Orthopedic Hospital of Henan Province (Henan Provincial Orthopedic Hospital),No. 82 Qiming South Road, Luoyang, Luoyang, 471000, China; +86 379-63546181; hnslyzgyyllwyh@aliyun.com), ref: 2026YJSKT0022-02
Health condition(s) or problem(s) studied	Tibiofibular fractures (closed tibial shaft fractures)
Intervention	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-printed reduction brace, which was combined with closed reduction and percutaneous fixation. Preoperative CT data were employed for three-dimensional reconstruction, virtual reduction simulation, and the design of individualized braces. During the surgical procedure, the customized 3D-printed brace was applied to guide fracture reduction and facilitate Kirschner wire fixation through pre-designed channels. The control group underwent conventional suprapatellar intramedullary nail fixation under fluoroscopic guidance. Both groups received standardized postoperative nursing care, including anticoagulation therapy, infection prophylaxis, and rehabilitation training, according to the same postoperative protocol. There is no follow up.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Digital intelligence-based 3D-printed reduction brace
Primary outcome measure(s)	Operative time measured using Minutes measured from skin incision to wound closure using operating room record at At the end of surgery Intraoperative fluoroscopy frequency measured using Number of times C-arm fluoroscopy is used during the operation (recorded by operating room staff) at During surgery Intraoperative blood loss measured using Estimated blood loss in milliliters (mL) using suction canister measurement and weighing of surgical gauze/swabs at During surgery
Key secondary outcome measure(s)
Completion date	01/09/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	12 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	30
Total final enrolment	28
Key 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
Key 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
Date of first enrolment	01/09/2025
Date of final enrolment	01/02/2026

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

21/05/2026: Trial's existence confirmed by Ethics Committee of Henan Luoyang Orthopedic Hospital (Henan Provincial Orthopedic Hospital).