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

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ClinicalTrials.gov Identifier: NCT03358784
Recruitment Status : Not yet recruiting
First Posted : December 2, 2017
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Zhang Peixun, Peking University People's Hospital

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

Condition or disease Intervention/treatment
Humeral Fracture, Proximal Procedure: Hemi-shoulder Arthroplasty Procedure: PHILOS Plate

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: A Multi-center Study on Comparison of Hemi-shoulder Arthroplasty and PHILOS in Treating Three or Four-part Fractures of Proximal Humerus.
Estimated Study Start Date : March 5, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: 6 months after surgery ]
    Postoperative complications were observed


Secondary Outcome Measures :
  1. EQ-5D [ Time Frame: 6 months after surgery ]
    EQ-5D was used to evaluate quality of life

  2. ASES score [ Time Frame: 6 months after surgery ]
    ASES was used to assess functional outcomes



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358784


Contacts
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Contact: Yichong Zhang, MD 15210802766 875274428@qq.com

Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Peixun Zhang, MD Peking University People's Hospital

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Responsible Party: Zhang Peixun, Department of orthopaedics and trauma, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03358784     History of Changes
Other Study ID Numbers: PUPH2017PHF
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhang Peixun, Peking University People's Hospital:
Humeral Fractures, Proximal
Arthroplasty, Shoulder Replacement
Bone Plates

Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries
Shoulder Injuries