- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07238517
Diagnostic Utility of Musculoskeletal Ultrasound in Early Postoperative Evaluation of Posttraumatic Repaired Hand Tendons.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hand tendon injuries are among the most frequent traumatic lesions of the upper extremity, representing a major cause of emergency and elective surgeries. Despite advances in surgical techniques, these injuries remain challenging due to the risk of postoperative complications such as rupture, adhesions, infection, and impaired tendon gliding. Early recognition of such complications is essential to prevent long-term stiffness, disability, and functional loss .
Postoperative assessment traditionally relies on clinical examination, but this may be limited by pain, swelling, dressings, or poor patient compliance, and subtle complications may not be evident until significant dysfunction develops. Hence, there is a need for a reliable, non-invasive modality to aid early detection and guide timely intervention.
Musculoskeletal ultrasound (MSK-US) has become an important tool for evaluating tendon injuries. It offers high spatial resolution, dynamic real-time imaging, absence of ionizing radiation, cost-effectiveness, and broad availability. In postoperative settings, MSK-US provides valuable information on tendon continuity, vascularity, surrounding soft tissue changes, and the presence of adhesions or fluid collections. Its ability to assess tendon motion dynamically further enhances its role in monitoring functional recovery.
Evidence indicates that MSK-US can detect complications such as rerupture, adhesions, or infection earlier than clinical examination, supporting its role as an adjunctive modality in follow-up. However, standardized use of ultrasound in routine postoperative surveillance of repaired hand tendons has not yet been established.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Abdelazeem Salah Rajeh
- Phone Number: +201006603514
- Email: AbdElazeem.17289819@med.aun.edu.eg
Study Locations
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Asyut, Egypt
- Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: adults with primary hand tendon repair and able to return for US follow-up.
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Exclusion Criteria: Patients with collagen disease, congenital hand deformities, bone fractures, revision/staged repairs, active infection/poor wound access, or can't attend follow-up.
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Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diagnostic accuracy of musculoskeletal ultrasound (MSK-US) for detecting clinically significant postoperative complications
Time Frame: Up to 12 weeks after surgical repair
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The accuracy of musculoskeletal ultrasound (MSK-US) in identifying clinically significant postoperative complications following surgical repair of posttraumatic hand tendons. Complications include rerupture requiring reintervention, deep infection, symptomatic adhesion requiring surgical release, and large seroma or hematoma requiring drainage or evacuation. Diagnostic accuracy will be determined by comparing MSK-US findings to a composite clinical reference standard consisting of surgical findings, clinical assessment, and microbiological/imaging confirmation. Accuracy measures will include sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratios. |
Up to 12 weeks after surgical repair
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Time from surgery to detection of postoperative complication by musculoskeletal ultrasound (MSK-US) versus clinical assessment
Time Frame: Up to 12 weeks after surgical repair
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Up to 12 weeks after surgical repair
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nagham Nabeel Omar, Assiut University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MSK-US repaired hand tendon
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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