Ultrasound EvaluationNCT07238517
Diagnostic Utility of Musculoskeletal Ultrasound in Early Postoperative Evaluation of Posttraumatic Repaired Hand Tendons.
An observational study of Ultrasound Evaluation and Hand Tendon Injury, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate the role of musculoskeletal ultrasound in the early postoperative period following hand tendon repair. By assessing its diagnostic accuracy and clinical utility, the study seeks to determine whether routine MSK-US surveillance can contribute to earlier detection of complications, guide timely management… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ultrasound Evaluation, Hand Tendon Injury
- What is being tested?
- MSK US
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to Nov 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who undergone hand tendon repair after trauma
Inclusion Criteria: adults with primary hand tendon repair and able to return for US follow-up.
-
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.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
To evaluate the role of musculoskeletal ultrasound in the early postoperative period following hand tendon repair. By assessing its diagnostic accuracy and clinical utility, the study seeks to determine whether routine MSK-US surveillance can contribute to earlier detection of complications, guide timely management decisions, and ultimately improve functional outcomes in patients undergoing hand tendon surgery.
Read the 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.
- Conditions
- Ultrasound Evaluation, Hand Tendon Injury
- Being tested
- MSK US
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSK USDevice
Focus on early postoperative (first 6-12 weeks) assessment after post-traumatic tendon repair.
Utilization of high-frequency dynamic ultrasound rather than static imaging or delayed MRI.
Standardized scanning protocol and blinded interpretation to ensure diagnostic validity.
Designed to evaluate the diagnostic utility of MSK-US compared with conventional clinical follow-up methods.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of musculoskeletal ultrasound (MSK-US) for detecting clinically significant postoperative complications
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.
Measured: Up to 12 weeks after surgical repair
Secondary outcomes (1)
Time from surgery to detection of postoperative complication by musculoskeletal ultrasound (MSK-US) versus clinical assessment
Measured: Up to 12 weeks after surgical repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jul 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound EvaluationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelazeem Salah Abdelazeem Rajeh, Assiut University
- Investigators
- Nagham Nabeel Omar, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238517
- Sponsor's protocol ID
- MSK-US repaired hand tendon
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Utility of Musculoskeletal Ultrasound in Early Postoperative Evaluation of Posttraumatic Repaired Hand Tendons.
- ClinicalTrials.gov ID
- NCT07238517
- Acronym / sponsor ID
- MSK-US repaired hand tendon
- Conditions
- Ultrasound Evaluation, Hand Tendon Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 20 Nov 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.
To evaluate the role of musculoskeletal ultrasound in the early postoperative period following hand tendon repair. By assessing its diagnostic accuracy and clinical utility, the study seeks to determine whether routine MSK-US surveillance can contribute to earlier detection of complications, guide timely management decisions, and ultimately improve functional outcomes in patients undergoing hand tendon surgery.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who undergone hand tendon repair after trauma
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 |
|---|---|---|
| MSK USFocus on early postoperative (first 6-12 weeks) assessment after post-traumatic tendon repair. Utilization of high-frequency dynamic ultrasound rather than static imaging or delayed MRI. Standardized scanning protocol and blinded interpretation to ensure diagnostic validity. Designed to evaluate the diagnostic utility of MSK-US compared with conventional clinical follow-up methods. | Device | – |
Primary outcome
Diagnostic accuracy of musculoskeletal ultrasound (MSK-US) for detecting clinically significant postoperative complications
Time frame: Up to 12 weeks after surgical repair
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.
1 secondary outcome
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
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 Nov 2025.
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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.
Nagham Nabeel Omar study director
Assiut University
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 Ultrasound Evaluation and Hand Tendon Injury, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 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 Egypt. 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 Abdelazeem Salah Rajeh (+201006603514, AbdElazeem.17289819@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of musculoskeletal ultrasound (MSK-US) for detecting clinically significant postoperative complications (time frame: Up to 12 weeks after surgical repair). 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 Nov 2025.