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A clinical prognostic study comparing the anatomical intramedullary nail and locking plate for the treatment of proximal humerus fractures

A clinical prognostic study comparing the anatomical intramedullary nail and locking plate for the treatment of proximal humerus fractures

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038167
Enrollment
Unknown
Registered
2020-09-11
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Proximal humeral fractures

Interventions

Experimental group:anatomical intramedullary nail
Control group:locking plate

Sponsors

General Hospital of Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients with age >=45 years old; 2. Patients with proximal humeral fractures; 3. Patients with bone mass displacement greater than 1 cm or turnover angle > 45.

Exclusion criteria

Exclusion criteria: 1. Patients with history of shoulder joint trauma, shoulder surgery and bone nonunion; 2. Patients with severe osteoarthritis, rheumatoid arthritis or pathological fracture or open fracture; 3. Patients with systemic diseases (including severe hemorrhagic diseases, serious heart diseases, severe respiratory diseases, and others who cannot tolerate anesthesia or surgery); 4. Patients with coagulation dysfunction; 5. Patients who can not accept radiation during operation; 6. Patients who can't tolerate the requirement of operation position; 7. Patients who are allergic to implant materials; 8. Patients with local or systemic active infection lesions; 9. Patients with mental illness, drug abuse and alcoholism; 10. Women in family planning, lactation and pregnancy during the whole clinical study period; 11. The patient is mentally incapable or unable to understand the requirements of participating in the study and is difficult to cooperate with; 12. Patients who have participated in the clinical research of other drugs, biological agents or medical devices in the past 3 months; 13. Patients with other diseases are limited to participate in the study and cannot follow up, which affects the scientific integrity of the study; 14. Patients who do not cooperate with or are not conducive to treatment and postoperative rehabilitation exercise.

Design outcomes

Primary

MeasureTime frame
Reduction Lose;neck-shaft angle;

Secondary

MeasureTime frame
Fracture healing time;rate of fracture healing;operation time;length of incision;blood loss;should range of motion;soft tissue infection;bone infection;neuro-vascular injury;costant-morrey score;DASH score;Other postoperative complications;

Countries

China

Contacts

Public ContactHua Chen

General Hospital of Chinese People's Liberation Army

chenhua0270@126.com+86 13910068413

Outcome results

None listed

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