NCT07238517

Brief 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 decisions, and ultimately improve functional outcomes in patients undergoing hand tendon surgery.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
16mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

November 16, 2025

Last Update Submit

November 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Up to 12 weeks after surgical repair

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who undergone hand tendon repair after trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Study Officials

  • Nagham Nabeel Omar

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations