- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07775690
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
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
150
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 Contact
- Name: Dr Jahanzaib Ramay, MBBS
- Phone Number: +923317787687
- Email: jahanzaibramay@hotmail.com
Study Locations
-
-
Punjab Province
-
Sāhīwāl, Punjab Province, Pakistan, 57450
- Recruiting
- Sahiwal Teaching Hospital
-
Contact:
- Dr Kashif Raza Khan, MBBS, FCPS
- Phone Number: +923338960200
- Email: drkashif14@yahoo.com
-
-
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
- 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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
Collaborators
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)
February 17, 2026
Primary Completion (Estimated)
August 17, 2026
Study Completion (Estimated)
August 17, 2026
Study Registration Dates
First Submitted
August 16, 2026
First Submitted That Met QC Criteria
August 16, 2026
First Posted (Actual)
August 20, 2026
Study Record Updates
Last Update Posted (Actual)
August 20, 2026
Last Update Submitted That Met QC Criteria
August 16, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Other Study ID 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.