Percutaneous Kirschner Wires With Mutual Linking Technique in the Management of Proximal Humeral Fracture

October 24, 2024 updated by: Tony Maher, Ain Shams University
This is study evaluates a novel technique to improve the stability of K-wires used in the fixation of proximal humeral fractures

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 6023
        • Ain Shams University Hospitals

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • both sexes
  • Age from 60 to80 years
  • 2 or 3 parts fracture
  • recent injury less than 3 weeks

Exclusion Criteria:

  • 4 parts fracture
  • old injury more than 3 weeks
  • previous surgeries or pathologies affecting shoulder range of motion

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elderly patients with proximal humeral fractures Neer type 2 and 3
Both sexes, age from 60 to 80
Procedure: Closed reduction and fixation by K- wires
Fixation by k-wires with mutual linking technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome
Time Frame: One year
Shoulder functional status using the American shoulder and elbow surgeons score (ASES) range from 0 to100, 0 being the worst and 100 being the best
One year
Radiological outcome
Time Frame: 8 weeks
The percentage of patients achieving union of the fracture assesed by plain X-ray shoulder anteroposterior and lateral views.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

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)

September 6, 2023

Primary Completion (Actual)

July 12, 2024

Study Completion (Actual)

September 6, 2024

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • proximal humeral fracture

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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