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Completed

NCT Number: NCT06571695

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

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.

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Key information

Conditions

Biceps Tendon Disorder Muscular Diseases Musculoskeletal Diseases Rotator Cuff Injuries Rupture Shoulder Injuries Tendinopathy Tendinosis Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anatomic Long Head of Biceps Tensioning Technique

Procedure

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

Traditional Long Head of Biceps Tensioning Technique

Procedure

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

Primary outcomes

  1. Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

    Time frame: 6 weeks

    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.

  2. Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

    Time frame: 3 months

    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.

  3. Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

    Time frame: 6 months

    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.

  4. Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

    Time frame: 1 year

    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.

  5. Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

    Time frame: 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 outcomes

  1. Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups

    Time frame: 6 weeks

    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.

  2. Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups

    Time frame: 3 months

    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.

  3. Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups

    Time frame: 6 months

    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.

  4. Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups

    Time frame: 1 year

    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.

  5. Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups

    Time frame: 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.

  6. Comparison of Active Forward Flexion Between Treatment and Control Groups

    Time frame: 6 weeks

    Active forward flexion of the shoulder measured from 0 to 180 degrees

  7. Comparison of Active Forward Flexion Between Treatment and Control Groups

    Time frame: 3 months

    Active forward flexion of the shoulder measured from 0 to 180 degrees

  8. Comparison of Active Forward Flexion Between Treatment and Control Groups

    Time frame: 6 months

    Active forward flexion of the shoulder measured from 0 to 180 degrees

  9. Comparison of Active Forward Flexion Between Treatment and Control Groups

    Time frame: 1 year

    Active forward flexion of the shoulder measured from 0 to 180 degrees

  10. Comparison of Active External Rotation Between Treatment and Control Groups

    Time frame: 6 weeks

    Active external rotation of the shoulder measured from 0 to 90 degrees

  11. Comparison of Active External Rotation Between Treatment and Control Groups

    Time frame: 3 months

    Active external rotation of the shoulder measured from 0 to 90 degrees

  12. Comparison of Active External Rotation Between Treatment and Control Groups

    Time frame: 6 months

    Active external rotation of the shoulder measured from 0 to 90 degrees

  13. Comparison of Active External Rotation Between Treatment and Control Groups

    Time frame: 1 year

    Active external rotation of the shoulder measured from 0 to 90 degrees

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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