NCT03023956

Brief Summary

From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were treated in our hospital. According to anatomic neck fractures (ANF) and surgical neck fractures (SNF), we divided the patients into two groups. All the patients were followed at least 1 year.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

July 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

January 12, 2017

Last Update Submit

January 22, 2017

Conditions

Humeral Fracture, ProximalInternal Fixation; Complications, Mechanical, Bones of Limb

Outcome Measures

Primary Outcomes (1)

  • change of head-shaft angle at 12months from 6months in two groups

    12months

Secondary Outcomes (3)

  • change of Offset at 12months from 6months in two groups

    12 months

  • Constant-Murly scores at 3 months, 12 months and last follow-up

    3 months,12 months,last follow-up (last follow-up means recent evaluation before database lock, it is more than 12months )

  • change of the distance between the screw tip and the subchondral surface(TSD) at 12months from 6months in two groups

    12 months

Study Arms (2)

ANF

anatomic neck fractures of proximal humerus

Procedure: Locking plates were used for proximal humeral fractures.

SNF

surgical neck fractures of proximal humerus

Procedure: Locking plates were used for proximal humeral fractures.

Interventions

Locking plates were used for proximal humeral fractures.PROCEDURE
ANFSNF

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

From May ,2013 to April 2015, patients with fractures of the proximal humerus who were treated with locking plate.

You may qualify if:

  • From May ,2013 to April 2015, patients with fractures of the proximal humerus who were treated with locking plate.

You may not qualify if:

  • Patients had pathologic fractures,
  • Patients had previous surgery on the affected shoulder,
  • Patients were treated with shoulder arthroplasty.
  • Patients were treated with intramedullary nail.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 18, 2017

Study Start

July 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 3, 2017

Last Updated

January 24, 2017

Record last verified: 2017-01