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

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

Study Locations

      • Asyut, Egypt
        • Assiut University
        • Contact:
          • Amany Omar, Vice dean of graduate studies
          • Phone Number: +20 +2088 22080150
          • Email: vp_grad@aun.edu.eg

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.

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

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.

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