NCT03833414

Brief Summary

observational study at tertiary care hospital and level 1 trauma centre aiming to evaluate the difference between two common surgical approaches to distal humerus fracture fixation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 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

January 1, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

5.9 years

First QC Date

February 6, 2019

Last Update Submit

February 7, 2019

Conditions

Keywords

intra-articular fractures; distal humerus; osteotomy; elbow joint

Outcome Measures

Primary Outcomes (1)

  • Functional outcome using Quick DASH Score

    Disabilities of Arm, Shoulder \& Hand

    1 years followup

Study Arms (2)

(Group1)

Triceps lifting approach .

Procedure: triceps lifting and olecranon osteotomy approaches

(Group 2)

olecranon osteotomy approach

Procedure: triceps lifting and olecranon osteotomy approaches

Interventions

two different surgical approaches for distal humerus fracture

(Group 2)(Group1)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all adult patients males and females who met the eligibility criteria.

You may qualify if:

  • All patients \>18 years of age with closed complex intra-articular distal humerus fracture (Intercondylar Fracture Riseborough Radin Classification type lll and lV) were included.

You may not qualify if:

  • Patients with CVA (Cerebero-Vascular Accident), dementia and associated with neurovascular injuries which may impede with rehabilitation are excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Humeral Fractures, DistalIntra-Articular Fractures

Condition Hierarchy (Ancestors)

Elbow FracturesElbow InjuriesArm InjuriesWounds and InjuriesHumeral FracturesFractures, Bone

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
admin assistant

Study Record Dates

First Submitted

February 6, 2019

First Posted

February 7, 2019

Study Start

January 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

not allowed according to hospital policy