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Status unknownNCT03358784Updated Dec 2, 2017

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

An observational study in Humeral Fracture, Proximal, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-12-02.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
300
Ages
60 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Humeral Fracture, Proximal

Keywords

  • Humeral Fractures, Proximal
  • Arthroplasty, Shoulder Replacement
  • Bone Plates
03

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

three or four part fractures of proximal humerus

Exclusion criteria

Exclusion Criteria:

  1. Severe comminuted fractures of proximal humerus
  2. past history of injured-side shoulder surgery
  3. Patients who cannot tolerate surgery
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • PHILOS Plate

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

    Procedure: PHILOS Plate

  • Hemi-shoulder arthroplasty

    three or four-part fractures of proximal humerus treated with hemi-shoulder arthroplasty

    Procedure: Hemi-shoulder Arthroplasty

Interventions

  • ProcedureHemi-shoulder Arthroplasty

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

  • ProcedurePHILOS Plate

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

05

What researchers measure

Primary outcomes

  1. Postoperative complications

    Postoperative complications were observed

    Time frame: 6 months after surgery

Secondary outcomes

  1. EQ-5D

    EQ-5D was used to evaluate quality of life

    Time frame: 6 months after surgery

  2. ASES score

    ASES was used to assess functional outcomes

    Time frame: 6 months after surgery

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03358784
Lead sponsor
Peking University People's Hospital
Responsible party
Zhang Peixun (Department of orthopaedics and trauma, Peking University People's Hospital) — Principal investigator
First posted
Dec 2, 2017
Start date
Mar 5, 2018 (estimated)
Primary completion
Mar 1, 2019 (estimated)
Completion
Mar 1, 2019 (estimated)
Last update
Dec 2, 2017

Study contacts

Yichong Zhang, MD
Contact
875274428@qq.com
15210802766
Peixun Zhang, MD
principal investigator · Peking University People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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