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

September 18, 2024 updated by: Dane Salazar, Loyola University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Procedure: 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
Active Comparator: 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.
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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 months
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.
6 months
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.
1 year
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.
1.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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 months
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.
6 months
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.
1 year
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.
1.5 years
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
6 weeks
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
3 months
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
6 months
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
1 year
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
6 weeks
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
3 months
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
6 months
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loyola University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 212671

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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