Does Surgical-approach Affect Outcome After Fixation of I... | NCT03833414

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

NCT03833414

Sponsor

Aga Khan University

Status

Completed

Last Update Posted

Feb 8, 2019Actual

Enrollment

43Actual

Phase

Not provided

Conditions

Distal Humerus Fracture

Interventions

triceps lifting and olecranon osteotomy approaches

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010Actual

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Feb 6, 2019

First Submission Date that Met QC Criteria

Feb 6, 2019

First Posted Date

Feb 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2019

Last Update Posted Date

Feb 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
(Group1)		Triceps lifting approach .	Procedure: triceps lifting and olecranon osteotomy approaches
(Group 2)		olecranon osteotomy approach	Procedure: triceps lifting and olecranon osteotomy approaches

Interventions

Name	Type	Description	Arm Group Labels	Other Names
triceps lifting and olecranon osteotomy approaches	Procedure	two different surgical approaches for distal humerus fracture	(Group 2) (Group1)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional outcome using Quick DASH Score	Disabilities of Arm, Shoulder & Hand	1 years followup

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

not allowed according to hospital policy

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000092483	Humeral Fractures, Distal
D057072	Intra-Articular Fractures

Ancestor Terms

ID	Term
D000092482	Elbow Fractures
D000092464	Elbow Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries

Browse Leaves

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Browse Branches

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