- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03833414
Does Surgical-approach Affect Outcome After Fixation of Intra-articular Fractures of Distal Humerus?
February 7, 2019 updated by: Aziz Hayder, Aga Khan University
Surgical Approach for Distal Humerus Fracture
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
43
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all adult patients males and females who met the eligibility criteria.
Description
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:
- Patients with CVA (Cerebero-Vascular Accident), dementia and associated with neurovascular injuries which may impede with rehabilitation are excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
(Group1)
Triceps lifting approach .
|
two different surgical approaches for distal humerus fracture
|
(Group 2)
olecranon osteotomy approach
|
two different surgical approaches for distal humerus fracture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional outcome using Quick DASH Score
Time Frame: 1 years followup
|
Disabilities of Arm, Shoulder & Hand
|
1 years followup
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2010
Primary Completion (ACTUAL)
December 1, 2015
Study Completion (ACTUAL)
December 1, 2015
Study Registration Dates
First Submitted
February 6, 2019
First Submitted That Met QC Criteria
February 6, 2019
First Posted (ACTUAL)
February 7, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2019
Last Update Submitted That Met QC Criteria
February 7, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3799-Sur-ERC-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
not allowed according to hospital policy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Distal Humerus Fracture
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Tokyo Medical UniversityRecruitingDistal Humerus FractureJapan
-
The Orthopaedic Research & Innovation FoundationUnknown
-
Herlev and Gentofte HospitalRecruitingIntra-Articular Fractures | Distal Humerus Fracture | Comminuted FractureDenmark
-
Royal Devon and Exeter NHS Foundation TrustNot yet recruitingDistal Humerus FractureUnited Kingdom
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Eckehart SCHÖLLBasel Academy for Quality and Research in Medicine; Prof. Dr. Werner Vach... and other collaboratorsRecruitingElbow Fracture | Elbow Sprain | Distal Humerus Fracture | Radial Head Fracture | Coronoid Process FractureSwitzerland
-
Linkoeping UniversityGöteborg UniversityActive, not recruitingDistal Humerus FractureSweden
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Synthes GmbHSynthes Australia Pty LtdWithdrawnProximal or Diaphyseal Humerus Fracture | Diaphyseal or Distal Femur Fracture | Diaphyseal, Distal or Proximal Tibia FractureAustralia
-
Technical University of MunichCompletedDistal Humerus Fracture
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The University of Hong KongRecruitingProximal Humeral Fracture | Distal Humerus Fracture | Distal Femur Fracture | Distal Tibia FractureHong Kong
-
Zuyderland Medisch CentrumActive, not recruitingUpper Extremity Fracture | Fracture of Distal End of Radius | Fracture of Proximal End of Humerus | Upper Limb FractureNetherlands