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Clinical Study on Safety and Efficacy of a New 3D Reticulated Metal-Aluminum Resin Composite External Fixation Material in Upper Limbs

Clinical Study on Safety and Efficacy of a New 3D Reticulated Metal-Aluminum Resin Composite External Fixation Material in Upper Limbs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124539
Enrollment
Unknown
Registered
2026-05-13
Start date
2026-05-15
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

External Fixation for Injuries of Upper Limbs

Interventions

Experimental group:Use a 3D mesh metal-aluminum resin mixture, soften it in thermostatic water, mold it into shape for fixation, then blow-dry.
Control Group:Use traditional plaster, soften it in warm water, mold it into shape for fixation.

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18–65 years with upper limb injury requiring external fixation, encompassing: unilateral closed fractures of the upper limb (finger, metacarpal, forearm, and elbow fractures, AO Types A/B), patients following closed reduction of unilateral elbow dislocation, and postoperative patients with unilateral tendon or nerve injury necessitating external immobilization; 2. Interval from injury to reduction or surgical intervention not exceeding 72 hours; 3. Provision of voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe osteoporosis (T-score 8%); 2. History of allergy to metal/resin materials; 3. Prior surgical history or malunion history at the injury site.

Design outcomes

Primary

MeasureTime frame
Incidence rate of complications;

Secondary

MeasureTime frame
Edema resolution rate;Visual Analogue Scale score;Joint functional recovery;

Countries

China

Contacts

Public ContactXianyou Zheng

Shanghai Sixth People's Hospital

sjqjswy@foxmail.com+86 64369181

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026