Humeral Shaft FracturesNCT07775690
Open Reduction and Internal Fixation of Humeral Midshaft Fracture: Anterior Versus Posterior Plate Fixation
A study testing Open Reduction Internal Fixation (ORIF) using Anterior approach for plate fixation and Open Reduction Internal Fixation (ORIF) using Posterior approach for plate fixation in people with Humeral Shaft Fractures, run by Dr Jahanzaib Ramay at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Humeral Shaft Fractures
- What is being tested?
- Open Reduction Internal Fixation (ORIF) using Anterior approach for plate fixation and Open Reduction Internal Fixation (ORIF) using Posterior approach for plate fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Feb 2026to 17 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presenting with humeral midshaft fracture (presence of fracture in the middle part or center of humerus )
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Sahiwal Teaching Hospital
Sāhīwāl, Punjab Province, 57450
Dr Kashif Raza Khan, MBBS, FCPS, +923338960200, drkashif14@yahoo.com
About this study
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.
- Conditions
- Humeral Shaft Fractures
- Being tested
- Open Reduction Internal Fixation (ORIF) using Anterior approach for plate fixation, Open Reduction Internal Fixation (ORIF) using Posterior approach for plate fixation
- Keywords
- Anterior plate fixation, Posterior plate fixation, Open reduction, Internal fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Reduction Internal Fixation (ORIF) using Anterior approach for plate fixationProcedure or surgery
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.
Open Reduction Internal Fixation (ORIF) using Posterior approach for plate fixationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A participants | Experimental | 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. Receives: Procedure: Open Reduction Internal Fixation (ORIF) using Anterior approach for plate fixation |
| Group B participants | Active comparator | 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. Receives: Procedure: Open Reduction Internal Fixation (ORIF) using Posterior approach for plate fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
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.
Measured: 3 Months
Bone union
It will be labeled if there is detectable callus bridge or at least three visible cortices on radiographs
Measured: 3 Months
American Shoulder and Elbow Surgeons Score (ASES)
It will be assessed after 3 months of surgery
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start17 Feb 2026
- Primary completion17 Aug 2026 (estimated)
- Study completion17 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral Shaft FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Jahanzaib Ramay
- Sponsor type
- University, hospital or other
- Collaborators
- Sahiwal Teaching Hospital
- Responsible party
- Sponsor-investigator, Dr Jahanzaib Ramay, Sahiwal Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775690
- Sponsor's protocol ID
- 440
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Reduction and Internal Fixation of Humeral Midshaft Fracture: Anterior Versus Posterior Plate Fixation
- ClinicalTrials.gov ID
- NCT07775690
- Acronym / sponsor ID
- 440
- Conditions
- Humeral Shaft Fractures
- Keywords
- Anterior plate fixation, Posterior plate fixation, Open reduction, Internal fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dr Jahanzaib RamayUniversity, hospital or other
- Collaborators
- Sahiwal Teaching Hospital
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 17 Aug 2026 (estimated)
- Study completion
- 17 Aug 2026 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A participants | Experimental | Procedure: Open Reduction Internal Fixation (ORIF) using Anterior approach for plate fixationAfter 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. |
| Group B participants | Active comparator | Procedure: Open Reduction Internal Fixation (ORIF) using Posterior approach for plate fixationAfter 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. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Presenting with humeral midshaft fracture (presence of fracture in the middle part or center of humerus )
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Reduction Internal Fixation (ORIF) using Anterior approach for plate fixationIn 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. | Procedure or surgery | Group A participants |
| Open Reduction Internal Fixation (ORIF) using Posterior approach for plate fixationIn 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. | Procedure or surgery | Group B participants |
Primary outcome
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.
Bone union
Time frame: 3 Months
It will be labeled if there is detectable callus bridge or at least three visible cortices on radiographs
American Shoulder and Elbow Surgeons Score (ASES)
Time frame: 3 Months
It will be assessed after 3 months of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Reduction Internal Fixation (ORIF) using Anterior approach for plate fixation and Open Reduction Internal Fixation (ORIF) using Posterior approach for plate fixation in people with Humeral Shaft Fractures, run by Dr Jahanzaib Ramay at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Jahanzaib Ramay, MBBS (+923317787687, jahanzaibramay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.