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

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

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

Study Overview

• Status: Unknown
• Conditions: Humeral Fracture, Proximal
• Intervention / Treatment: Procedure: PHILOS Plate; Procedure: Hemi-shoulder Arthroplasty

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with three or four part fractures of proximal humerus, who agreed to receive surgery.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PHILOS Plate; three or four-part fractures of proximal humerus treated with internal fixation	Procedure: PHILOS Plate; PHILOS plate treating three or four-part fractures of proximal humerus
Hemi-shoulder arthroplasty; three or four-part fractures of proximal humerus treated with hemi-shoulder arthroplasty	Procedure: Hemi-shoulder Arthroplasty; Hemi-shoulder Arthroplasty treating three or four-part fractures of proximal humerus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications were observed	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D	EQ-5D was used to evaluate quality of life	6 months after surgery
ASES score	ASES was used to assess functional outcomes	6 months after surgery

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Peixun Zhang, MD, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 5, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: November 26, 2017
• First Submitted That Met QC Criteria: November 26, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 26, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Humeral Fractures, Proximal; Arthroplasty, Shoulder Replacement; Bone Plates
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: PUPH2017PHF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No