Humerus Shaft FractureNCT07286734
Ultrasound Assesment Of Radial Nerve In Humeral Shaft Fracture Patients With Radial Palsy
An observational study of Humerus Shaft Fracture and Radial Nerve Palsy, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates how well ultrasound imaging can identify damage to the radial nerve in patients with a broken upper arm bone (humeral shaft fracture). Some of these patients also have weakness or paralysis in their hand and wrist due to injury to the radial nerve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humerus Shaft Fracture, Radial Nerve Palsy
- What is being tested?
- High-Resolution Ultrasound Evaluation of the Radial Nerve
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to Feb 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting with acute traumatic humeral shaft fractures at a tertiary care orthopedic center. Patients are assigned to cohorts based on the presence or absence of clinical radial nerve palsy. All participants undergo standard diagnostic and therapeutic procedures, with targeted ultrasound used for nerve assessment in the radial palsy group.
Who may be able to join
- Adult patients aged 18 years or older.
- Diagnosed with traumatic humeral shaft fracture.
- Admitted and followed according to the local clinical protocol with a confirmed diagnosis.
- Underwent required investigations, including high-resolution ultrasonography and/or electromyography (EMG).
- Provided written informed consent to participate in the study.
Who cannot join
- Pathological fractures due to malignancy or metabolic disorder.
- History of previous humeral fracture or pre-traumatic radial nerve deficit.
- Clinically detected vascular injury or major soft tissue loss accompanying the fracture.
- Incomplete diagnostic workup (absence of ultrasound or EMG examination).
- Declined participation or were lost to follow-up.
- Persons under 18 years of age.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University
Istanbul, Kars, 34722
Tolga Onay, Associate Professor, 00905054418123, tolgaonay.md@gmail.com
About this study
This study investigates how well ultrasound imaging can identify damage to the radial nerve in patients with a broken upper arm bone (humeral shaft fracture). Some of these patients also have weakness or paralysis in their hand and wrist due to injury to the radial nerve. The study compares patients with and without radial nerve problems to see if early ultrasound scans can accurately detect nerve damage before surgery.
All patients will receive standard care, including surgery to fix the fracture. Those with nerve problems will also have the nerve explored during surgery. The results of the ultrasound will be compared to what is found during the operation. Patients will be followed closely over 12 months to monitor nerve recovery, healing of the bone, and any complications.
The goal is to improve the early diagnosis and management of nerve injuries in arm fractures, using a safe, non-invasive ultrasound scan that could help guide treatment decisions.
- Conditions
- Humerus Shaft Fracture, Radial Nerve Palsy
- Being tested
- High-Resolution Ultrasound Evaluation of the Radial Nerve
- Medical subject headings
- Radial Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Resolution Ultrasound Evaluation of the Radial NerveDevice
High-resolution diagnostic ultrasound of the radial nerve is performed using a linear transducer (6-15 MHz) within 48 hours of admission in patients with humeral shaft fractures. The ultrasound systematically assesses the radial nerve's continuity, morphology, and relation to the fracture site. Based on established classification criteria (e.g., stretch neuropraxia, incarceration, partial/complete transection), the ultrasound findings guide intraoperative planning. All imaging is performed by board-certified musculoskeletal radiologists following a standardized protocol.
| Study group | Role | What they receive |
|---|---|---|
| Radial Nerve Palsy Group | Patients with humeral shaft facture and Radial Nerve Palsy Receives: Device: High-Resolution Ultrasound Evaluation of the Radial Nerve | |
| No radial Nerve Palsy | Patients with humeral shaft fracture but no radial nerve palsy Receives: Device: High-Resolution Ultrasound Evaluation of the Radial Nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Ultrasound Accuracy in Detecting Radial Nerve Continuity
This outcome assesses how accurately high-resolution ultrasonography identifies whether the radial nerve is intact in patients with humeral shaft fractures and radial nerve palsy. The ultrasound findings will be compared to surgical exploration results (reference standard). Diagnostic accuracy metrics include sensitivity, specificity, positive predictive value, and negative predictive value.
Measured: Baseline (within 48 hours of admission); confirmation at surgery
Secondary outcomes (2)
Correlation Between Ultrasound Classification and Intraoperative Radial Nerve Findings
Ultrasound-based classification of radial nerve injury (e.g., stretch, incarceration, partial/complete transection) will be compared with intraoperative findings to assess diagnostic agreement. Additional analyses will evaluate the relationship between USG classification and postoperative functional outcomes
Measured: Baseline (ultrasound), Intraoperative, and Postoperative (3, 6, and 12 months)
Functional Recovery of Radial Nerve Motor and Sensory Function
Recovery of motor function (wrist/finger/thumb extension) will be evaluated using the Medical Research Council (MRC) scale (0-5). Sensory recovery will be assessed via light touch and pinprick sensation in the radial nerve territory. Outcomes include proportion of patients with full, partial, or no recovery, and time to initial and full improvement.
Measured: 1, 3, 6, and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jan 2024
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humerus Shaft FractureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Gumus, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286734
- Sponsor's protocol ID
- IstanbulMU_032025
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 16 Dec 2025
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assesment Of Radial Nerve In Humeral Shaft Fracture Patients With Radial Palsy
- ClinicalTrials.gov ID
- NCT07286734
- Acronym / sponsor ID
- IstanbulMU_032025
- Conditions
- Humerus Shaft Fracture, Radial Nerve Palsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 16 Dec 2025 (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.
This study investigates how well ultrasound imaging can identify damage to the radial nerve in patients with a broken upper arm bone (humeral shaft fracture). Some of these patients also have weakness or paralysis in their hand and wrist due to injury to the radial nerve. The study compares patients with and without radial nerve problems to see if early ultrasound scans can accurately detect nerve damage before surgery.
All patients will receive standard care, including surgery to fix the fracture. Those with nerve problems will also have the nerve explored during surgery. The results of the ultrasound will be compared to what is found during the operation. Patients will be followed closely over 12 months to monitor nerve recovery, healing of the bone, and any complications.
The goal is to improve the early diagnosis and management of nerve injuries in arm fractures, using a safe, non-invasive ultrasound scan that could help guide treatment decisions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial Nerve Palsy Group | – | Device: High-Resolution Ultrasound Evaluation of the Radial NervePatients with humeral shaft facture and Radial Nerve Palsy |
| No radial Nerve Palsy | – | Device: High-Resolution Ultrasound Evaluation of the Radial NervePatients with humeral shaft fracture but no radial nerve palsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting with acute traumatic humeral shaft fractures at a tertiary care orthopedic center. Patients are assigned to cohorts based on the presence or absence of clinical radial nerve palsy. All participants undergo standard diagnostic and therapeutic procedures, with targeted ultrasound used for nerve assessment in the radial palsy group.
Key inclusion criteria (5 listed)
- Adult patients aged 18 years or older.
- Diagnosed with traumatic humeral shaft fracture.
- Admitted and followed according to the local clinical protocol with a confirmed diagnosis.
- Underwent required investigations, including high-resolution ultrasonography and/or electromyography (EMG).
- Provided written informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Pathological fractures due to malignancy or metabolic disorder.
- History of previous humeral fracture or pre-traumatic radial nerve deficit.
- Clinically detected vascular injury or major soft tissue loss accompanying the fracture.
- Incomplete diagnostic workup (absence of ultrasound or EMG examination).
- Declined participation or were lost to follow-up.
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 |
|---|---|---|
| High-Resolution Ultrasound Evaluation of the Radial NerveHigh-resolution diagnostic ultrasound of the radial nerve is performed using a linear transducer (6-15 MHz) within 48 hours of admission in patients with humeral shaft fractures. The ultrasound systematically assesses the radial nerve's continuity, morphology, and relation to the fracture site. Based on established classification criteria (e.g., stretch neuropraxia, incarceration, partial/complete transection), the ultrasound findings guide intraoperative planning. All imaging is performed by board-certified musculoskeletal radiologists following a standardized protocol. | Device | No radial Nerve Palsy, Radial Nerve Palsy Group |
Primary outcome
Preoperative Ultrasound Accuracy in Detecting Radial Nerve Continuity
Time frame: Baseline (within 48 hours of admission); confirmation at surgery
This outcome assesses how accurately high-resolution ultrasonography identifies whether the radial nerve is intact in patients with humeral shaft fractures and radial nerve palsy. The ultrasound findings will be compared to surgical exploration results (reference standard). Diagnostic accuracy metrics include sensitivity, specificity, positive predictive value, and negative predictive value.
2 secondary outcomes
Correlation Between Ultrasound Classification and Intraoperative Radial Nerve Findings
Time frame: Baseline (ultrasound), Intraoperative, and Postoperative (3, 6, and 12 months)
Functional Recovery of Radial Nerve Motor and Sensory Function
Time frame: 1, 3, 6, and 12 months postoperatively
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 16 Dec 2025.
- 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?
An observational study of Humerus Shaft Fracture and Radial Nerve Palsy, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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 16 Dec 2025. 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 Turkey (Türkiye). 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 Mehmed Nuri Tutuncu, MD (0090 531 265 33 79, mnuritutuncu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Ultrasound Accuracy in Detecting Radial Nerve Continuity (time frame: Baseline (within 48 hours of admission); confirmation at surgery). 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 16 Dec 2025.