Comparison of Hemi-shoulder Arthroplasty and PHILOS in Treating Three or Four-part Fractures of Proximal Humerus

Humeral Fracture, Proximal Clinical Trial

Official title:

A Multi-center Study on Comparison of Hemi-shoulder Arthroplasty and PHILOS in Treating Three or Four-part Fractures of Proximal Humerus.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03358784
• Other study ID #: PUPH2017PHF
• Status: Not yet recruiting
• Phase: N/A
• First received: November 26, 2017
• Last updated: November 26, 2017
• Start date: March 5, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: November 2017
• Source: Peking University People's Hospital
• Contact: Yichong Zhang, MD
• Phone: 15210802766
• Email: 875274428[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To explore clinical effectiveness of PHILOS plate fixation and hemi-shoulder arthroplasty in treating three or four-part fractures of proximal humerus

Description:

From April 2015 and April 2017, patients from multi-center aged over 60 years old with three and four-part fractures of proximal humerus were treated with Proximal Humerus Internal Locking System(PHILOS) and hemi-shoulder arthroplasty in multi-center. All the patients received the same rehabilitation course. At 6 months after surgery, postoperative complications were observed, EQ-5D was used to evaluate quality of life, and ASES score was used to assess functional outcomes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

three or four part fractures of proximal humerus

Exclusion Criteria:

1. Severe comminuted fractures of proximal humerus

2. past history of injured-side shoulder surgery

3. Patients who cannot tolerate surgery

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fracture, Proximal
• Humeral Fractures
• Shoulder Fractures

Intervention

Procedure:
• Hemi-shoulder Arthroplasty
Hemi-shoulder Arthroplasty treating three or four-part fractures of proximal humerus
• PHILOS Plate
PHILOS plate treating three or four-part fractures of proximal humerus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Postoperative complications were observed	6 months after surgery
Secondary	EQ-5D	EQ-5D was used to evaluate quality of life	6 months after surgery
Secondary	ASES score	ASES was used to assess functional outcomes	6 months after surgery