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Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis

NCT06571695 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2024-11-20

Study results available
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Summary

The goal of this clinical trial is to determine the clinical impact of restoring the anatomic-tension relationship of the long head of the biceps (LHB) when performing a biceps tenotomy and tenodesis. The main question it aims to answer is whether anatomic tensioning will improve functional outcome scores and decrease postoperative complications. The investigators hypothesize that through a standardized method of anatomically tensioning the LHB tendon during tenodesis, patient outcomes will improve. Researchers will compare these outcomes to a control group receiving the traditional tensioning technique. Participants will be randomized to either the anatomic tensioning treatment group or the traditional tensioning control group.

Conditions

  • Biceps Tendon Disorder
  • Tendinosis
  • Rotator Cuff Injuries

Interventions

PROCEDURE

Anatomic Long Head of Biceps Tensioning Technique

The standard mini-open subpectoral approach will be made. The myotendinous junction of the long head of the biceps tendon and its location within the intertubercular groove will be marked using electrocautery. The surgeon will then turn to the glenohumeral joint and perform the biceps tenotomy.The long head of the biceps tendon will be retrieved.The tendon is tagged with a running, locking number 2 fiberwire suture at the mid substance of the myotendinous junction using the previously made electrocautery marks to set the tension. The tendon is shortened. The sutures from the biceps are passed through the Arthrex cortical button.The pectoralis major tendon is retracted and 2 centimeters proximal to the distal insertion a unicortical bone tunnel is drilled in the bicipital groove with a 3.2 millimeter drill.The wound is irrigated and the biceps button is threaded into this tunnel and then flipped.The suture is tensioned, securing the biceps against the groove

PROCEDURE

Traditional Long Head of Biceps Tensioning Technique

Diagnostic arthroscopic shoulder scope will occur to assess the long head of the biceps for tendinopathy. Tenotomy will occur at the junction of the supraglenoid tubercle with arthroscopic scissors. Subsequent tensioning and tenodesis will be based on surgeon's preference

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-27
Primary Completion
2024-02-20
Completion
2024-02-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06571695 on ClinicalTrials.gov