Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT06571695

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

Official Title:

Long Head of the Biceps Subpectoral Tenodesis Anatomic vs. Traditional Tensioning Technique During Rotator Cuff Repair: A Randomized Prospective Trial

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.

Eligibility

Inclusion Criteria:

* Patients at least 18 years of age undergoing arthroscopic shoulder surgery
* Operations that occur at Loyola University Medical Center (Maywood, IL), Loyola Ambulatory Surgery Center (Maywood, IL), or Gottlieb Memorial Hospital

Exclusion Criteria:

* Previous shoulder surgery involving the long head of the biceps tendon
* Younger than 18 years old
* Current pregnancy. As per standard protocol with all surgeries, a urine pregnancy test is performed prior to surgery. If positive, the surgery will be cancelled and the patient will be excluded from the research study.

Disease(s) and\or Condition(s)

Biceps Tendon Disorder

Tendinosis

Rotator Cuff Injuries

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: PROCEDURE
    • Name: Anatomic Long Head of Biceps Tensioning Technique
    • Description: 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
    • Arm Group Labels: Anatomic Long Head of Biceps Tensioning Technique
    • Type: PROCEDURE
    • Name: Traditional Long Head of Biceps Tensioning Technique
    • Description: 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
    • Arm Group Labels: Traditional Long Head of Biceps Tensioning Technique
Sponsor
  • Loyola University