Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis
NCT Number: NCT06571695
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Biceps Tendon Disorder|Tendinosis|Rotator Cuff Injuries
Interventions: PROCEDURE: Anatomic Long Head of Biceps Tensioning Technique|PROCEDURE: Traditional Long Head of Biceps Tensioning Technique
Sponsor: Loyola University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 167
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2020-10-27
Completion Date: 2024-02-20
Locations: Loyola University Medical Center, Maywood, Illinois, 60153, United States

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.

Primary Outcome Measures: Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups, 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 weeks|Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups, 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., 6 weeks|Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups, 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 months|Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups, 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., 6 months|Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups, 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., 1 year
Secondary Outcome Measures: Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups, 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 weeks|Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups, 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 weeks|Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups, 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 months|Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups, 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 months|Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups, 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., 1 year|Comparison of Range of Motion Between Treatment and Control Groups, Active forward flexion of the shoulder measured from 0 to 180 degrees and active external rotation of the shoulder measured from 0 to 90 degrees., 2 weeks|Comparison of Range of Motion Between Treatment and Control Groups, Active forward flexion of the shoulder measured from 0 to 180 degrees and active external rotation of the shoulder measured from 0 to 90 degrees., 6 weeks|Comparison of Range of Motion Between Treatment and Control Groups, Active forward flexion of the shoulder measured from 0 to 180 degrees and active external rotation of the shoulder measured from 0 to 90 degrees., 3 months|Comparison of Range of Motion Between Treatment and Control Groups, Active forward flexion of the shoulder measured from 0 to 180 degrees and active external rotation of the shoulder measured from 0 to 90 degrees., 6 months|Comparison of Range of Motion Between Treatment and Control Groups, Active forward flexion of the shoulder measured from 0 to 180 degrees and active external rotation of the shoulder measured from 0 to 90 degrees., 1 year