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

NCT ID: NCT03358784

Last Updated: 2017-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-05

Study Completion Date

2019-03-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Humeral Fracture, Proximal

Keywords

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Humeral Fractures, Proximal Arthroplasty, Shoulder Replacement Bone Plates

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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PHILOS Plate

three or four-part fractures of proximal humerus treated with internal fixation

PHILOS Plate

Intervention Type PROCEDURE

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

Hemi-shoulder Arthroplasty

Intervention Type PROCEDURE

Hemi-shoulder Arthroplasty treating three or four-part fractures of proximal humerus

Interventions

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Hemi-shoulder Arthroplasty

Hemi-shoulder Arthroplasty treating three or four-part fractures of proximal humerus

Intervention Type PROCEDURE

PHILOS Plate

PHILOS plate treating three or four-part fractures of proximal humerus

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang Peixun

Department of orthopaedics and trauma

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peixun Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Central Contacts

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Yichong Zhang, MD

Role: CONTACT

Phone: 15210802766

Email: [email protected]

Other Identifiers

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PUPH2017PHF

Identifier Type: -

Identifier Source: org_study_id