Comparison of Hemi-shoulder Arthroplasty and PHILOS in Tr... | NCT03358784

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

NCT03358784

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Dec 2, 2017Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Humeral Fracture, Proximal

Interventions

Hemi-shoulder Arthroplasty
PHILOS Plate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2018Estimated

Primary Completion Date

Mar 1, 2019Estimated

Completion Date

Mar 1, 2019Estimated

First Submitted Date

Nov 26, 2017

First Submission Date that Met QC Criteria

Nov 26, 2017

First Posted Date

Dec 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2017

Last Update Posted Date

Dec 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhang Peixun, Department of orthopaedics and trauma, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hemi-shoulder Arthroplasty	Procedure	Hemi-shoulder Arthroplasty treating three or four-part fractures of proximal humerus	Hemi-shoulder arthroplasty

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

three or four part fractures of proximal humerus

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yichong Zhang, MD	Contact	15210802766		875274428@qq.com

Overall Officials

Name	Affiliation	Role
Peixun Zhang, MD	Peking University People's Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012784	Shoulder Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D000070599	Shoulder Injuries

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Browse Branches

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