Open Reduction and Internal Fixation of Humeral Midshaft Fracture: Anterior Versus Posterior Plate Fixation

August 16, 2026 updated by: Dr Jahanzaib Ramay
About 13 out of 10,000 patients get a humeral shaft fracture each year, accounting for 1.0-3.0% of all fractures. The central part of the humerus is where 60% of all humeral fractures occur. A midshaft humerus fracture typically happens because of a direct impact to the upper arm. Trauma, such as falls, motor vehicle accidents, or motorcycle accidents, is the most common cause of fractures. Internally fixing humeral shaft fractures is often accomplished by a variety of surgical techniques. Usually, the posterior technique is used to repair distal and mid-shaft fractures. However, the posterior technique necessitates lateral or prone stance. The aim of this study comparing the outcomes of internal fixation and open reduction of humeral midshaft fractures utilizing anterior and posterior plate fixation. We want to conduct this study to get evidence to confirm whether which approach is more appropriate and more successful in such fractures. Moreover, the findings of this research could profoundly influence clinical outcomes by guiding orthopedic surgeons in their decision-making for management of humeral midshaft fracture.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab Province
      • Sāhīwāl, Punjab Province, Pakistan, 57450
        • Recruiting
        • Sahiwal Teaching Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Presenting with humeral midshaft fracture (presence of fracture in the middle part or center of humerus )

Exclusion Criteria:

  • Patients with pathological or open fractures, concomitant fractures or ligament or tendon ruptures of elbow or shoulder joints (on clinical examination)
  • Patients presented after 14 days of injury, partial or complete disability of the elbow or shoulder joint on the affected side before injury
  • Previous surgical procedure on same side
  • Presence of neurovascular complications
  • Apparent dementia or other psychological problems

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A participants
After getting approval from ethical review board. Written informed consent will be taken. The participants will be randomly assigned two groups using lottery method. In group A, 75 Participants will undergo ORIF by using anterior approach for plate fixation. Operative time will be noted. After surgery, patients will be shifted to post-surgical orthopedic wards and will be discharged from there. All patients will be followed-up in OPD for 3 months. After 3 months, plain x-ray will be done to assess the bone union . Patients will also be examined for ASES score by researcher and presence of postoperative radial nerve palsy will also be evaluated. All the data will be recorded in Performa.
Procedure: Open Reduction Internal Fixation (ORIF) using Anterior approach for plate fixation
In group A, participants will undergo ORIF by using anterior approach for plate fixation. Operative time will be noted. After surgery, patients will be shifted to post-surgical orthopedic wards and will be discharged from there. All patients will be followed-up in OPD for 3 months.
Active Comparator: Group B participants
After getting approval from ethical review board. Written informed consent will be taken. The participants will be randomly assigned two groups using lottery method. In group B, 75 Participants will undergo ORIF by using posterior approach for plate fixation. Operative time will be noted. After surgery, patients will be shifted to post-surgical orthopedic wards and will be discharged from there. All patients will be followed-up in OPD for 3 months. After 3 months, plain x-ray will be done to assess the bone union . Patients will also be examined for ASES score by researcher and presence of postoperative radial nerve palsy will also be evaluated. All the data will be recorded in Performa.
Procedure: Open Reduction Internal Fixation (ORIF) using Posterior approach for plate fixation
In group B, participants will undergo ORIF by using posterior approach for plate fixation. Operative time will be noted. After surgery, patients will be shifted to post-surgical orthopedic wards and will be discharged from there. All patients will be followed-up in OPD for 3 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: 3 Months
It will be assessed by using in terms of minutes required to perform surgery from time of incision given in the skin until closure of skin with stitches.
3 Months
Bone union
Time Frame: 3 Months
It will be labeled if there is detectable callus bridge or at least three visible cortices on radiographs
3 Months
American Shoulder and Elbow Surgeons Score (ASES)
Time Frame: 3 Months
It will be assessed after 3 months of surgery
3 Months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr Jahanzaib Ramay

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sahiwal Teaching Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 440

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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