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

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ClinicalTrials.gov Identifier: NCT03833414
Recruitment Status : Completed
First Posted : February 7, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Aziz Hayder, Aga Khan University

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.

Condition or disease Intervention/treatment
Distal Humerus Fracture Procedure: triceps lifting and olecranon osteotomy approaches

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.

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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Surgical Approach for Distal Humerus Fracture
Actual Study Start Date : January 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
(Group1)
Triceps lifting approach .
Procedure: triceps lifting and olecranon osteotomy approaches
two different surgical approaches for distal humerus fracture

(Group 2)
olecranon osteotomy approach
Procedure: triceps lifting and olecranon osteotomy approaches
two different surgical approaches for distal humerus fracture




Primary Outcome Measures :
  1. Functional outcome using Quick DASH Score [ Time Frame: 1 years followup ]
    Disabilities of Arm, Shoulder & Hand



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
all adult patients males and females who met the eligibility criteria.
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:

  • Patients with CVA (Cerebero-Vascular Accident), dementia and associated with neurovascular injuries which may impede with rehabilitation are excluded
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Responsible Party: Aziz Hayder, admin assistant, Aga Khan University
ClinicalTrials.gov Identifier: NCT03833414    
Other Study ID Numbers: 3799-Sur-ERC-15
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: not allowed according to hospital policy

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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 Aziz Hayder, Aga Khan University:
intra-articular fractures; distal humerus; osteotomy; elbow joint
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Intra-Articular Fractures
Wounds and Injuries
Arm Injuries