NCT03358784

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

12 months

First QC Date

November 26, 2017

Last Update Submit

November 26, 2017

Conditions

Humeral Fracture, Proximal

Keywords

Humeral Fractures, ProximalArthroplasty, Shoulder ReplacementBone Plates

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Postoperative complications were observed

    6 months after surgery

Secondary Outcomes (2)

  • EQ-5D

    6 months after surgery

  • ASES score

    6 months after surgery

Study Arms (2)

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

Hemi-shoulder ArthroplastyPROCEDURE

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

Hemi-shoulder arthroplasty
PHILOS PlatePROCEDURE

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

PHILOS Plate

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • three or four part fractures of proximal humerus

You may not qualify if:

  • Severe comminuted fractures of proximal humerus
  • past history of injured-side shoulder surgery
  • Patients who cannot tolerate surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Study Officials

  • Peixun Zhang, MD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yichong Zhang, MD

CONTACT

15210802766875274428@qq.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of orthopaedics and trauma

Study Record Dates

First Submitted

November 26, 2017

First Posted

December 2, 2017

Study Start

March 5, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

December 2, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share