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CompletedNCT03833414Updated Feb 8, 2019

Does Surgical-approach Affect Outcome After Fixation of Intra-articular Fractures of Distal Humerus?

An observational study in Distal Humerus Fracture, sponsored by Aga Khan University. Completed. Per ClinicalTrials.gov, last updated 2019-02-08.

Sponsored by Aga Khan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
43
Sex
All
01

Study 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.

Read the detailed description

Fractures around the distal humerus fractures make up to 2% of all fractures. Complex intra-articular distal humerus fractures present as challenge to restore of painless, stable and mobile elbow joint. Surgical exposure to all critical structures is of paramount importance to achieve anatomic reduction. Conflict still persists regarding the choice of ideal approach between triceps-sparing approach compared with olecranon osteotomy approach. In this study investigators compare the effect of surgical approach triceps lifting vs olecranon osteotomy on the functional outcome after fixation of distal humerus intra-articular fractures. Investigators conducted a non-funded, non-commercial, retrospective cohort study on participants with closed distal humerus intra-articular fractures between 2010 and 2015 at our tertiary care level-1 trauma and university hospital. Participants >18 years of age with closed complex intra-articular distal humerus fracture were operated using two different surgical approaches, either triceps lifting approach (Group1) or with olecranon osteotomy (Group 2). Functional evaluation of the participant is carried out with quick DASH scores at the final 1 year follow-up. Investigators concluded that triceps lifting approach can be used equally efficiently for exposure of these complex distal humerus injuries with no comprise in visibility of articular fragments.

02

Conditions studied

  • Distal Humerus Fracture

Keywords

  • intra-articular fractures; distal humerus; osteotomy; elbow joint
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 43 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients with CVA (Cerebero-Vascular Accident), dementia and associated with neurovascular injuries which may impede with rehabilitation are excluded
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
43 participants (actual)
Patient registry
No

Groups and cohorts

  • (Group1)

    Triceps lifting approach .

    Procedure: triceps lifting and olecranon osteotomy approaches

  • (Group 2)

    olecranon osteotomy approach

    Procedure: triceps lifting and olecranon osteotomy approaches

Interventions

  • Proceduretriceps lifting and olecranon osteotomy approaches

    two different surgical approaches for distal humerus fracture

06

What researchers measure

Primary outcomes

  1. Functional outcome using Quick DASH Score

    Disabilities of Arm, Shoulder \& Hand

    Time frame: 1 years followup

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — not allowed according to hospital policy

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03833414
Lead sponsor
Aga Khan University
Responsible party
Aziz Hayder (admin assistant, Aga Khan University) — Principal investigator
First posted
Feb 7, 2019
Start date
Jan 2010
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Feb 8, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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