Trial Outcomes & Findings for Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis (NCT NCT06571695)
NCT ID: NCT06571695
Last Updated: 2024-11-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
204 participants
Primary outcome timeframe
6 weeks
Results posted on
2024-11-20
Participant Flow
From October 2020 to December 2022, 204 consecutive patients from Loyola University Medical Center were initially assessed for eligibility. The first participant was enrolled in October 27, 2020 and the last participant was enrolled in December 6, 2022.
Of 204 enrolled participants, 167 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
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.
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
|
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.
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
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
87
|
|
Overall Study
COMPLETED
|
79
|
81
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
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.
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
|
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.
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
6
|
Baseline Characteristics
Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis
Baseline characteristics by cohort
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=80 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=87 Participants
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.
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
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.8 years
n=5 Participants
|
56.2 years
n=7 Participants
|
55.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Body Mass Index
|
30.8 kg/m^2
STANDARD_DEVIATION 6.3 • n=5 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 6.0 • n=7 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Rotator Cuff Anteroposterior Tear Size
|
11.3 millimeters
STANDARD_DEVIATION 7.6 • n=5 Participants
|
13.0 millimeters
STANDARD_DEVIATION 8.2 • n=7 Participants
|
12.2 millimeters
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Surgery Right Side Laterality
|
50 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
American Shoulder and Elbow Surgeons Score
|
42.4 units on a scale
STANDARD_DEVIATION 21.6 • n=5 Participants
|
37.5 units on a scale
STANDARD_DEVIATION 18.1 • n=7 Participants
|
39.9 units on a scale
STANDARD_DEVIATION 20.0 • n=5 Participants
|
|
Visual Analog Scale Pain Score
|
5.7 units on a scale
STANDARD_DEVIATION 2.8 • n=5 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Active Forward Flexion
|
138.9 degrees
STANDARD_DEVIATION 29.4 • n=5 Participants
|
138.2 degrees
STANDARD_DEVIATION 26.1 • n=7 Participants
|
138.5 degrees
STANDARD_DEVIATION 27.7 • n=5 Participants
|
|
Active External Rotation
|
45.8 degrees
STANDARD_DEVIATION 13.4 • n=5 Participants
|
47.0 degrees
STANDARD_DEVIATION 10.6 • n=7 Participants
|
46.4 degrees
STANDARD_DEVIATION 12.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=44 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=39 Participants
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.
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
|
|---|---|---|
|
Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
|
47.1 units on a scale
Standard Error 20.7
|
37.1 units on a scale
Standard Error 17.1
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=44 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=46 Participants
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.
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
|
|---|---|---|
|
Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
|
59.5 units on a scale
Standard Deviation 22.8
|
58.3 units on a scale
Standard Deviation 22.5
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=39 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=38 Participants
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.
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
|
|---|---|---|
|
Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
|
68.2 units on a scale
Standard Deviation 32.6
|
73.1 units on a scale
Standard Deviation 19.9
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=42 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=39 Participants
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.
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
|
|---|---|---|
|
Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
|
60.0 units on a scale
Standard Deviation 39.0
|
76.1 units on a scale
Standard Deviation 19.5
|
PRIMARY outcome
Timeframe: 1.5 yearsPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=79 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=81 Participants
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.
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
|
|---|---|---|
|
Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
|
78.3 units on a scale
Standard Deviation 22.5
|
77.3 units on a scale
Standard Deviation 22.9
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=29 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=38 Participants
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.
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
|
|---|---|---|
|
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
|
4.8 units on a scale
Standard Deviation 2.7
|
5.1 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=29 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=40 Participants
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.
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
|
|---|---|---|
|
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
|
3.6 units on a scale
Standard Deviation 2.6
|
4.1 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=27 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=37 Participants
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.
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
|
|---|---|---|
|
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
|
2.0 units on a scale
Standard Deviation 2.8
|
2.5 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=30 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=36 Participants
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.
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
|
|---|---|---|
|
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
|
1.5 units on a scale
Standard Deviation 2.6
|
2.3 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 1.5 yearsPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=62 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=50 Participants
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.
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
|
|---|---|---|
|
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
|
2.2 units on a scale
Standard Deviation 2.7
|
2.9 units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Intention to treat analysis
Active forward flexion of the shoulder measured from 0 to 180 degrees
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=63 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=72 Participants
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.
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
|
|---|---|---|
|
Comparison of Active Forward Flexion Between Treatment and Control Groups
|
107.0 degrees
Standard Deviation 45.1
|
97.8 degrees
Standard Deviation 42.6
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention to treat analysis
Active forward flexion of the shoulder measured from 0 to 180 degrees
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=66 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=76 Participants
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.
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
|
|---|---|---|
|
Comparison of Active Forward Flexion Between Treatment and Control Groups
|
138.7 degrees
Standard Deviation 28.7
|
138.9 degrees
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intention to treat analysis
Active forward flexion of the shoulder measured from 0 to 180 degrees
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=51 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=66 Participants
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.
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
|
|---|---|---|
|
Comparison of Active Forward Flexion Between Treatment and Control Groups
|
149.3 degrees
Standard Deviation 20.1
|
145.8 degrees
Standard Deviation 21.8
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intention to treat analysis
Active forward flexion of the shoulder measured from 0 to 180 degrees
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=16 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=21 Participants
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.
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
|
|---|---|---|
|
Comparison of Active Forward Flexion Between Treatment and Control Groups
|
150.3 degrees
Standard Deviation 10.7
|
139.0 degrees
Standard Deviation 28.5
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Intention to treat analysis
Active external rotation of the shoulder measured from 0 to 90 degrees
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=59 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=69 Participants
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.
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
|
|---|---|---|
|
Comparison of Active External Rotation Between Treatment and Control Groups
|
33.1 degrees
Standard Deviation 16.7
|
31.7 degrees
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention to treat analysis
Active external rotation of the shoulder measured from 0 to 90 degrees
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=64 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=74 Participants
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.
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
|
|---|---|---|
|
Comparison of Active External Rotation Between Treatment and Control Groups
|
43.1 degrees
Standard Deviation 11.1
|
42.5 degrees
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intention to treat analysis
Active external rotation of the shoulder measured from 0 to 90 degrees
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=44 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=60 Participants
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.
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
|
|---|---|---|
|
Comparison of Active External Rotation Between Treatment and Control Groups
|
46.3 degrees
Standard Deviation 8.5
|
45.5 degrees
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intention to treat analysis
Active external rotation of the shoulder measured from 0 to 90 degrees
Outcome measures
| Measure |
Anatomic Long Head of Biceps Tensioning Technique
n=13 Participants
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.
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
|
Traditional Long Head of Biceps Tensioning Technique
n=18 Participants
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.
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
|
|---|---|---|
|
Comparison of Active External Rotation Between Treatment and Control Groups
|
45.4 degrees
Standard Deviation 4.8
|
43.6 degrees
Standard Deviation 13.7
|
Adverse Events
Anatomic Long Head of Biceps Tensioning Technique
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Traditional Long Head of Biceps Tensioning Technique
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place