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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06571695

Enrollment

204

Registered

2024-08-26

Start date

2020-10-27

Completion date

2024-02-20

Last updated

2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biceps Tendon Disorder, Rotator Cuff Injuries, Tendinosis

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.

Interventions

PROCEDUREAnatomic 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

PROCEDURETraditional 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

The design will be a single blinded format where the surgeon will be aware of what treatment the patient will receive (Control vs. Intervention). The patient will not be informed of what arm of treatment they were selected for.

Intervention model description

Anatomic Long Head of Biceps Tensioning Treatment Group vs. Traditional Long Head of Biceps Tensioning Control Group

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups	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.

Secondary

Measure	Time frame	Description
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups	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.
Comparison of Active Forward Flexion Between Treatment and Control Groups	6 weeks	Active forward flexion of the shoulder measured from 0 to 180 degrees
Comparison of Active External Rotation Between Treatment and Control Groups	6 weeks	Active external rotation of the shoulder measured from 0 to 90 degrees

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

Of 204 enrolled participants, 167 met inclusion criteria and were randomized to treatment.

Participants by arm

Arm	Count
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	80
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	87
Total	167

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	6

Baseline characteristics

Characteristic	Total	Anatomic Long Head of Biceps Tensioning Technique	Traditional Long Head of Biceps Tensioning Technique
Active External Rotation	46.4 degrees STANDARD_DEVIATION 12.1	45.8 degrees STANDARD_DEVIATION 13.4	47.0 degrees STANDARD_DEVIATION 10.6
Active Forward Flexion	138.5 degrees STANDARD_DEVIATION 27.7	138.9 degrees STANDARD_DEVIATION 29.4	138.2 degrees STANDARD_DEVIATION 26.1
Age, Continuous	55.5 years	54.8 years	56.2 years
American Shoulder and Elbow Surgeons Score	39.9 units on a scale STANDARD_DEVIATION 20	42.4 units on a scale STANDARD_DEVIATION 21.6	37.5 units on a scale STANDARD_DEVIATION 18.1
Body Mass Index	30.9 kg/m^2 STANDARD_DEVIATION 6.1	30.8 kg/m^2 STANDARD_DEVIATION 6.3	30.9 kg/m^2 STANDARD_DEVIATION 6
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	22 Participants	6 Participants	16 Participants
Race (NIH/OMB) More than one race	33 Participants	13 Participants	20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants	2 Participants	2 Participants
Race (NIH/OMB) White	108 Participants	59 Participants	49 Participants
Region of Enrollment United States	167 Participants	80 Participants	87 Participants
Rotator Cuff Anteroposterior Tear Size	12.2 millimeters STANDARD_DEVIATION 7.9	11.3 millimeters STANDARD_DEVIATION 7.6	13.0 millimeters STANDARD_DEVIATION 8.2
Sex: Female, Male Female	74 Participants	36 Participants	38 Participants
Sex: Female, Male Male	93 Participants	44 Participants	49 Participants
Surgery Right Side Laterality	105 Participants	50 Participants	55 Participants
Visual Analog Scale Pain Score	5.9 units on a scale STANDARD_DEVIATION 2.6	5.7 units on a scale STANDARD_DEVIATION 2.8	6.1 units on a scale STANDARD_DEVIATION 2.4

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 80	0 / 87
other Total, other adverse events	0 / 80	0 / 87
serious Total, serious adverse events	0 / 80	0 / 87

Outcome results

Primary

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.

Time frame: 1 year