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Clinical Application Study of Additive-Manufactured Proximal Humeral Anatomical Intramedullary Support Prosthesis System in the Treatment of Elderly Patients with Comminuted Proximal Humeral Fractures — A Prospective, Multicenter, Randomized, Pragmatic Controlled Real-World Study

Clinical Application Study of Additive-Manufactured Proximal Humeral Anatomical Intramedullary Support Prosthesis System in the Treatment of Elderly Patients with Comminuted Proximal Humeral Fractures — A Prospective, Multicenter, Randomized, Pragmatic Controlled Real-World Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113520
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Proximal Humeral Fracture

Interventions

Experimental Group:Additive Manufacturing Proximal Humerus Anatomical Intramedullary Support Prosthesis System
Control Group:proximal humerus internal locking system

Sponsors

The Fourth Medical Center of the Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Subjects aged >= 60 years (including 60 years old), regardless of gender; 2.Three-part or four-part proximal humeral fractures; 3. Subjects who have not participated in other clinical trials within 3 months.

Exclusion criteria

Exclusion criteria: 1. A history of previous shoulder trauma, shoulder surgery, or nonunion of bones; 2.Severe osteoarthritis, rheumatoid arthritis, or pathological fractures; 3.Systemic diseases (including severe hemorrhagic diseases, severe heart diseases, severe respiratory diseases, and inability to tolerate anesthesia or surgery); 4. Complicated with severe nerve or vascular injury; 5.Allergy to implant materials; 6.Active infection foci in local parts or the whole body; 7. Mental illness or substance abuse; 8.Other conditions deemed unsuitable for enrollment by the researchers.

Design outcomes

Primary

MeasureTime frame
Amount of Reduction Loss;

Secondary

MeasureTime frame
Difference in Neck-Shaft Angle;DASH Score of the Affected Side;UCLA Score of the Affected Side;VAS Score of the Affected Side;Constant-Murley Score of the Affected Side;

Countries

China

Contacts

Public ContactChenhua

The Fourth Medical Center of the Chinese People's Liberation Army General Hospital

chenhua0270@126.com+86 139 1006 8413

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026