Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT07286734
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Assesment Of Radial Nerve In Humeral Shaft Fracture Patients With Radial Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020425', 'term': 'Radial Neuropathy'}], 'ancestors': [{'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-12-03', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative Ultrasound Accuracy in Detecting Radial Nerve Continuity', 'timeFrame': 'Baseline (within 48 hours of admission); confirmation at surgery', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Correlation Between Ultrasound Classification and Intraoperative Radial Nerve Findings', 'timeFrame': 'Baseline (ultrasound), Intraoperative, and Postoperative (3, 6, and 12 months)', 'description': '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'}, {'measure': 'Functional Recovery of Radial Nerve Motor and Sensory Function', 'timeFrame': '1, 3, 6, and 12 months postoperatively', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Humerus Shaft Fracture', 'Radial Nerve Palsy']}, 'descriptionModule': {'briefSummary': '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.\n\nAll 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Diagnosed with traumatic humeral shaft fracture.\n* Admitted and followed according to the local clinical protocol with a confirmed diagnosis.\n* Underwent required investigations, including high-resolution ultrasonography and/or electromyography (EMG).\n* Provided written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Pathological fractures due to malignancy or metabolic disorder.\n* History of previous humeral fracture or pre-traumatic radial nerve deficit.\n* Clinically detected vascular injury or major soft tissue loss accompanying the fracture.\n* Incomplete diagnostic workup (absence of ultrasound or EMG examination).\n* Declined participation or were lost to follow-up.\n* Persons under 18 years of age.'}, 'identificationModule': {'nctId': 'NCT07286734', 'briefTitle': 'Ultrasound Assesment Of Radial Nerve In Humeral Shaft Fracture Patients With Radial Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medeniyet University'}, 'officialTitle': 'Ultrasound Assesment Of Radial Nerve In Humeral Shaft Fracture Patients With Radial Palsy', 'orgStudyIdInfo': {'id': 'IstanbulMU_032025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radial Nerve Palsy Group', 'description': 'Patients with humeral shaft facture and Radial Nerve Palsy', 'interventionNames': ['Device: High-Resolution Ultrasound Evaluation of the Radial Nerve']}, {'label': 'No radial Nerve Palsy', 'description': 'Patients with humeral shaft fracture but no radial nerve palsy', 'interventionNames': ['Device: High-Resolution Ultrasound Evaluation of the Radial Nerve']}], 'interventions': [{'name': 'High-Resolution Ultrasound Evaluation of the Radial Nerve', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['No radial Nerve Palsy', 'Radial Nerve Palsy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34722', 'city': 'Istanbul', 'state': 'Kars', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Tolga Onay, Associate Professor', 'role': 'CONTACT', 'email': 'tolgaonay.md@gmail.com', 'phone': '00905054418123'}], 'facility': 'Istanbul Medeniyet University'}], 'centralContacts': [{'name': 'Mehmed Nuri Tutuncu, MD', 'role': 'CONTACT', 'email': 'mnuritutuncu@hotmail.com', 'phone': '0090 531 265 33 79'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medeniyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mahmut Gumus', 'investigatorAffiliation': 'Istanbul Medeniyet University'}}}}