- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06833398
Comparison Between Arthroscopic Simple Biceps Tenotomy & Anchor Technique Tenotomy with Clinical and Ultrasound Assessment
February 13, 2025 updated by: Ahmed Sayed Shehata, Assiut University
Arthroscopic Simple Biceps Tenotomy Versus Anchor Tenotomy Technique, Clinical Outcome and Ultrasound Assessment
Comparison between arthroscopic simple biceps tenotomy & anchor tenotomy technique regarding clinical outcomes & ultrasound assessment
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This research compares two surgical techniques for addressing pathologies of the long head of the biceps (LHB) tendon: arthroscopic simple biceps tenotomy and anchor tenotomy.
The LHB tendon, originating from the supraglenoid tubercle, plays a critical role in forearm supination, elbow flexion, and shoulder abduction.
Pathologies affecting this tendon often cause significant shoulder pain, with surgical options including tenotomy and tenodesis.
While simple tenotomy is quick and avoids implant complications, it may result in cosmetic deformities like the "Popeye" sign and muscle cramps.
Anchor tenotomy, a novel technique, aims to minimize these issues by preventing the Popeye deformity.
This study employs a prospective randomized double-blinded controlled trial design at Assiut University Hospitals, involving 72 patients with LHB pathologies such as tendinitis, rotator cuff tears, and subacromial impingement.
Exclusion criteria include prior tenodesis or neuromuscular diseases.
Clinical outcomes will be assessed using functional scores (e.g., Oxford Shoulder Score), ultrasound evaluation of tendon positioning, and follow-up examinations at intervals up to one year post-surgery.
The primary outcome focuses on the presence of the Popeye deformity, while secondary outcomes include postoperative shoulder function and tendon distalization measured via ultrasound.
This research aims to provide evidence-based insights into the comparative effectiveness of these two techniques in improving clinical outcomes and minimizing complications.
Study Type
Interventional
Enrollment (Estimated)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ahmed S shehata, bachelor of medicine
- Phone Number: 01010527046
- Email: Ahmed.15248388@med.aun.edu.eg
Study Locations
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Asyut, Egypt
- Assiut University
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Contact:
- Amany Omar, Vice dean of graduate studies
- Phone Number: +20 +2088 22080150
- Email: vp_grad@aun.edu.eg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with LHB pathologies such as :
Biceps tendinitis Rotator cuff tears Subacromial impengiment Instability & traumatic causes
Exclusion Criteria:
- LHB Tenodesis Patients with neuromuscular disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arthroscopic simple Biceps tenotomy
This group undergoes a straightforward arthroscopic procedure to release the LHB tendon.
The technique is quick and avoids the need for implants or prolonged rehabilitation.
However, it carries a risk of cosmetic deformities, such as the "Popeye" sign, and potential biceps muscle cramps postoperatively.
|
|
|
Experimental: anchor tenotomy technique
This group undergoes a novel anchor-based tenotomy technique.
The procedure aims to prevent the Popeye deformity by anchoring the released tendon in a specific position.
While technically more complex than simple tenotomy, it is designed to improve cosmetic outcomes and potentially reduce postoperative complications.
|
Anchor Tenotomy Technique: This is a novel arthroscopic method where, after releasing the LHB tendon, it is anchored in place to prevent distal migration.
The goal of this technique is to avoid the Popeye deformity and improve cosmetic outcomes while maintaining functional integrity.
This procedure is technically more challenging and may involve a longer operative time compared to simple tenotomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evaluate for popeye sign after arthroscopic simple biceps tenotomy vs anchor technique tenotomy
Time Frame: 1 year
|
clinical evaluation of shoulder function postoperative by dynamometer & US assessment of LHB tendon distalization after LHB tenotomy . Remove |
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 30, 2025
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
February 13, 2025
First Submitted That Met QC Criteria
February 13, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 13, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- biceps tenotomy technique
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Simple Biceps Tenotomy
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NYU Langone HealthTerminatedTenodesis | TenotomyUnited States
-
University Hospitals Cleveland Medical CenterWithdrawn
-
Assiut UniversityNot yet recruitingChildren With Simple Obesity
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Adiyaman University Research HospitalUnknownLocal Pressure Effects | Simple EarTurkey
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Assiut UniversityNot yet recruitingRotator Cuff Tear | Shoulder Injuries | SLAP Lesion | Lesion of Long Head of Biceps | Biceps Tendinopathy | Biceps Instability
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West Penn Allegheny Health SystemCompleted
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St. Louis UniversityTerminatedBicep Tendinitis | Biceps; Tenosynovitis | Biceps Tendon DisorderUnited States
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Second Affiliated Hospital, School of Medicine,...RecruitingAdults With Simple ObesityChina
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University of AlbertaCompleted
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West Penn Allegheny Health SystemCompleted
Clinical Trials on Anchor Tenotomy Technique:
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ConMed Linvatec BeijingCompleted
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-
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Smith & Nephew Orthopaedics AGCompletedInstability, JointSpain, Italy, United States, Denmark, Finland, United Kingdom
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