Comparison Between Arthroscopic Simple Biceps Tenotomy & Anchor Technique Tenotomy with Clinical and Ultrasound Assessment

NCT ID: NCT06833398

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-07-01

Brief Summary

Comparison between arthroscopic simple biceps tenotomy & anchor tenotomy technique regarding clinical outcomes & ultrasound assessment

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.

Conditions

Simple Biceps Tenotomy; Anchor Tenotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Anchor Tenotomy Technique:

Intervention Type: PROCEDURE

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.

Interventions

Arthroscopic Simple Biceps Tenotomy:

Arthroscopic Simple Biceps Tenotomy: This procedure involves an arthroscopic release of the LHB tendon from its attachment at the superior glenoid labrum. It is a quick and simple technique that does not require implants or extensive postoperative rehabilitation. The main drawback is the potential for developing a "Popeye" deformity, where the biceps muscle bulges due to distal migration, as well as occasional muscle cramps.

Intervention Type: PROCEDURE

Anchor Tenotomy Technique:

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Sayed Shehata

resident at the Orthopaedic and Trauma Surgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

Central Contacts

ahmed S shehata, bachelor of medicine

Role: CONTACT

Ahmed.15248388@med.aun.edu.eg

01010527046

Facility Contacts

Amany Omar, Vice dean of graduate studies

Role: primary

vp_grad@aun.edu.eg

+2088 22080150 ext. +20

Other Identifiers

biceps tenotomy technique

Identifier Type: -

Identifier Source: org_study_id