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

Not Applicable

Completed

Interventions: Procedure: Traditional Long Head of Biceps Tensioning Technique
Procedure: Anatomic Long Head of Biceps Tensioning Technique

Brief 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.

Detailed Description: The long head of the biceps can be a source of anterior shoulder pain that is primarily due to inflammation or instability of the long head of the biceps (LHB) tendon . Patients that fail non-operative management become candidates for biceps tenotomy and tenodesis. Currently, there is no universal protocol or gold standard for how the LHB tendon is tensioned. At the investigators' institution, the LHB is tensioned based on individual surgeon feel for the correct tensioning. The purpose of this study is to conduct a randomized, single-blinded prospective study comparing patients with the current regimen of bicep tensioning vs. utilizing a standardized method of anatomically tensioning the LHB tendon. The primary aim of assessing change in the American Shoulder and Elbow Surgeon (ASES) scores from baseline to post-surgery between the control and intervention groups will be assessed using a student's t-test. In addition, longitudinal mixed effects models will be used to estimate changes in ASES scores, over all time-points using a random effect for surgeon. Other relevant patient characteristics such as age, sex, and Charlson score will be included to explore the adjusted relationship of the intervention and outcomes over time. A secondary aim of this study is to collect specific measurements of the myotendinous junction of the LHB tendon to potentially establish if any characteristics predispose patients to developing pathology of the LHB tendon.

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
Traditional Long Head of Biceps Tensioning Technique	Traditional Long Head of Biceps Tensioning Technique	The control group patient will undergo biceps tenotomy and tenodesis based on surgeon feel on appropriate tensioning of the tendon (Current practice). Of note, there is no universal method or gold standard on how the long head of the biceps should be tensioned during bicep tenodesis.
Anatomic Long Head of Biceps Tensioning Technique	Anatomic Long Head of Biceps Tensioning Technique	Patients that are randomized to the intervention group will undergo biceps tenodesis in a standardized, step-by-step protocol as outlined in a previously published and publicly available article.

Primary Outcome Measures

Name	Time	Method
Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups	1.5 years	The ASES form was created by the Society of the American Shoulder and Elbow Surgeons to help standardize outcome measures by both combining a physician-rated and patient rated section. The total maximum score (and best outcome) is 100. Half of the score is weighted for pain and the other half for function. The final pain score is calculated by subtracting the visual analog scale from 10 and multiplying by 5. For the functional portion, each of the 10 separate questions are on a scale from 0 to 3. The functional portion total is then multiplied by 5/3 to make it a total of 50 points. In summary, 50 points come from the visual analog scale and the other 50 come from the functional portion, which equals a possible total of 100.

Secondary Outcome Measures

Name	Time	Method
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups	1.5 years	The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The score ranges from 0-10 with 0 being pain free and 10 being severe pain.
Comparison of Active Forward Flexion Between Treatment and Control Groups	1 year	Active forward flexion of the shoulder measured from 0 to 180 degrees
Comparison of Active External Rotation Between Treatment and Control Groups	1 year	Active external rotation of the shoulder measured from 0 to 90 degrees