Biceps Tendon DisorderNCT06571695
Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis
A study testing Anatomic Long Head of Biceps Tensioning Technique and Traditional Long Head of Biceps Tensioning Technique in people with Biceps Tendon Disorder and Tendinosis, run by Loyola University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biceps Tendon Disorder, Tendinosis, Rotator Cuff Injuries
- What is being tested?
- Anatomic Long Head of Biceps Tensioning Technique and Traditional Long Head of Biceps Tensioning Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2020to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: 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.
Read the 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.
- Conditions
- Biceps Tendon Disorder, Tendinosis, Rotator Cuff Injuries
- Being tested
- Anatomic Long Head of Biceps Tensioning Technique, Traditional Long Head of Biceps Tensioning Technique
- Medical subject headings
- Tendinopathy, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomic Long Head of Biceps Tensioning TechniqueProcedure or surgery
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 TechniqueProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Anatomic Long Head of Biceps Tensioning Technique | Experimental | 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. Receives: Procedure: Anatomic Long Head of Biceps Tensioning Technique |
| Traditional Long Head of Biceps Tensioning Technique | Active comparator | 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. Receives: Procedure: Traditional Long Head of Biceps Tensioning Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
The ASES form was created by the Society of the American Shoulder and Elbow Surgeons to help standardize outcome measures by both combining a physician-rated and patient rated section. The total maximum score (and best outcome) is 100. Half of the score is weighted for pain and the other half for function. The final pain score is calculated by subtracting the visual analog scale from 10 and multiplying by 5. For the functional portion, each of the 10 separate questions are on a scale from 0 to 3. The functional portion total is then multiplied by 5/3 to make it a total of 50 points. In summary, 50 points come from the visual analog scale and the other 50 come from the functional portion, which equals a possible total of 100.
Measured: 3 months
Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
The ASES form was created by the Society of the American Shoulder and Elbow Surgeons to help standardize outcome measures by both combining a physician-rated and patient rated section. The total maximum score (and best outcome) is 100. Half of the score is weighted for pain and the other half for function. The final pain score is calculated by subtracting the visual analog scale from 10 and multiplying by 5. For the functional portion, each of the 10 separate questions are on a scale from 0 to 3. The functional portion total is then multiplied by 5/3 to make it a total of 50 points. In summary, 50 points come from the visual analog scale and the other 50 come from the functional portion, which equals a possible total of 100.
Measured: 6 months
Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
The ASES form was created by the Society of the American Shoulder and Elbow Surgeons to help standardize outcome measures by both combining a physician-rated and patient rated section. The total maximum score (and best outcome) is 100. Half of the score is weighted for pain and the other half for function. The final pain score is calculated by subtracting the visual analog scale from 10 and multiplying by 5. For the functional portion, each of the 10 separate questions are on a scale from 0 to 3. The functional portion total is then multiplied by 5/3 to make it a total of 50 points. In summary, 50 points come from the visual analog scale and the other 50 come from the functional portion, which equals a possible total of 100.
Measured: 1 year
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.
Measured: 1.5 years
Secondary outcomes (13)
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The score ranges from 0-10 with 0 being pain free and 10 being severe pain.
Measured: 6 weeks
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The score ranges from 0-10 with 0 being pain free and 10 being severe pain.
Measured: 3 months
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The score ranges from 0-10 with 0 being pain free and 10 being severe pain.
Measured: 6 months
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The score ranges from 0-10 with 0 being pain free and 10 being severe pain.
Measured: 1 year
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The score ranges from 0-10 with 0 being pain free and 10 being severe pain.
Measured: 1.5 years
Comparison of Active Forward Flexion Between Treatment and Control Groups
Active forward flexion of the shoulder measured from 0 to 180 degrees
Measured: 6 weeks
Comparison of Active Forward Flexion Between Treatment and Control Groups
Active forward flexion of the shoulder measured from 0 to 180 degrees
Measured: 3 months
Comparison of Active Forward Flexion Between Treatment and Control Groups
Active forward flexion of the shoulder measured from 0 to 180 degrees
Measured: 6 months
Comparison of Active Forward Flexion Between Treatment and Control Groups
Active forward flexion of the shoulder measured from 0 to 180 degrees
Measured: 1 year
Comparison of Active External Rotation Between Treatment and Control Groups
Active external rotation of the shoulder measured from 0 to 90 degrees
Measured: 6 weeks
Comparison of Active External Rotation Between Treatment and Control Groups
Active external rotation of the shoulder measured from 0 to 90 degrees
Measured: 3 months
Comparison of Active External Rotation Between Treatment and Control Groups
Active external rotation of the shoulder measured from 0 to 90 degrees
Measured: 6 months
Comparison of Active External Rotation Between Treatment and Control Groups
Active external rotation of the shoulder measured from 0 to 90 degrees
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start27 Oct 2020
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Biceps Tendon DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Anatomic Long Head of Biceps Tensioning Treatment Group vs. Traditional Long Head of Biceps Tensioning Control Group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dane Salazar, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571695
- Sponsor's protocol ID
- 212671
- Status last verified
- Sep 2024
- First submitted
- 22 Aug 2024
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
David TS, Schildhorn JC. Arthroscopic suprapectoral tenodesis of the long head biceps: reproducing an anatomic length-tension relationship. Arthrosc Tech. 2012 Jul 21;1(1):e127-32. doi: 10.1016/j.eats.2012.05.004. Print 2012 Sep.
PubMed 23766967Denard PJ, Dai X, Hanypsiak BT, Burkhart SS. Anatomy of the biceps tendon: implications for restoring physiological length-tension relation during biceps tenodesis with interference screw fixation. Arthroscopy. 2012 Oct;28(10):1352-8. doi: 10.1016/j.arthro.2012.04.143. Epub 2012 Aug 24.
PubMed 22925883Hussain WM, Reddy D, Atanda A, Jones M, Schickendantz M, Terry MA. The longitudinal anatomy of the long head of the biceps tendon and implications on tenodesis. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1518-1523. doi: 10.1007/s00167-014-2909-5. Epub 2014 Feb 27.
PubMed 24573238Jarrett CD, McClelland WB Jr, Xerogeanes JW. Minimally invasive proximal biceps tenodesis: an anatomical study for optimal placement and safe surgical technique. J Shoulder Elbow Surg. 2011 Apr;20(3):477-80. doi: 10.1016/j.jse.2010.08.002. Epub 2010 Oct 12.
PubMed 20943419Lafrance R, Madsen W, Yaseen Z, Giordano B, Maloney M, Voloshin I. Relevant anatomic landmarks and measurements for biceps tenodesis. Am J Sports Med. 2013 Jun;41(6):1395-9. doi: 10.1177/0363546513482297. Epub 2013 Apr 5.
PubMed 23562807Tao MA, Calcei JG, Taylor SA. Biceps Tenodesis: Anatomic Tensioning. Arthrosc Tech. 2017 Jul 24;6(4):e1125-e1129. doi: 10.1016/j.eats.2017.03.033. eCollection 2017 Aug.
PubMed 29354407Wolf RS, Zheng N, Weichel D. Long head biceps tenotomy versus tenodesis: a cadaveric biomechanical analysis. Arthroscopy. 2005 Feb;21(2):182-5. doi: 10.1016/j.arthro.2004.10.014.
PubMed 15689867
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Head of the Biceps Subpectoral Tenodesis Anatomic vs. Traditional Tensioning Technique During Rotator Cuff Repair: A Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT06571695
- Acronym / sponsor ID
- 212671
- Conditions
- Biceps Tendon Disorder, Tendinosis, Rotator Cuff Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Posted 20 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Anatomic Long Head of Biceps Tensioning Treatment Group vs. Traditional Long Head of Biceps Tensioning Control Group
| Arm | Type | Receives |
|---|---|---|
| Anatomic Long Head of Biceps Tensioning Technique | Experimental | Procedure: Anatomic Long Head of Biceps Tensioning TechniquePatients 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. |
| Traditional Long Head of Biceps Tensioning Technique | Active comparator | Procedure: Traditional Long Head of Biceps Tensioning TechniqueThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomic Long Head of Biceps Tensioning TechniqueThe 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 | Procedure or surgery | Anatomic Long Head of Biceps Tensioning Technique |
| Traditional Long Head of Biceps Tensioning TechniqueDiagnostic 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 | Procedure or surgery | Traditional Long Head of Biceps Tensioning Technique |
Primary outcome
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.
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.
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.
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.
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.
13 secondary outcomes
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
Time frame: 6 weeks
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
Time frame: 3 months
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
Time frame: 6 months
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
Time frame: 1 year
Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
Time frame: 1.5 years
Comparison of Active Forward Flexion Between Treatment and Control Groups
Time frame: 6 weeks
Comparison of Active Forward Flexion Between Treatment and Control Groups
Time frame: 3 months
Comparison of Active Forward Flexion Between Treatment and Control Groups
Time frame: 6 months
Comparison of Active Forward Flexion Between Treatment and Control Groups
Time frame: 1 year
Comparison of Active External Rotation Between Treatment and Control Groups
Time frame: 6 weeks
Comparison of Active External Rotation Between Treatment and Control Groups
Time frame: 3 months
Comparison of Active External Rotation Between Treatment and Control Groups
Time frame: 6 months
Comparison of Active External Rotation Between Treatment and Control Groups
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23766967David TS, Schildhorn JC. Arthroscopic suprapectoral tenodesis of the long head biceps: reproducing an anatomic length-tension relationship. Arthrosc Tech. 2012 Jul 21;1(1):e127-32. doi: 10.1016/j.eats.2012.05.004. Print 2012 Sep.
- Background: PubMed 22925883Denard PJ, Dai X, Hanypsiak BT, Burkhart SS. Anatomy of the biceps tendon: implications for restoring physiological length-tension relation during biceps tenodesis with interference screw fixation. Arthroscopy. 2012 Oct;28(10):1352-8. doi: 10.1016/j.arthro.2012.04.143. Epub 2012 Aug 24.
- Background: PubMed 24573238Hussain WM, Reddy D, Atanda A, Jones M, Schickendantz M, Terry MA. The longitudinal anatomy of the long head of the biceps tendon and implications on tenodesis. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1518-1523. doi: 10.1007/s00167-014-2909-5. Epub 2014 Feb 27.
- Background: PubMed 20943419Jarrett CD, McClelland WB Jr, Xerogeanes JW. Minimally invasive proximal biceps tenodesis: an anatomical study for optimal placement and safe surgical technique. J Shoulder Elbow Surg. 2011 Apr;20(3):477-80. doi: 10.1016/j.jse.2010.08.002. Epub 2010 Oct 12.
- Background: PubMed 23562807Lafrance R, Madsen W, Yaseen Z, Giordano B, Maloney M, Voloshin I. Relevant anatomic landmarks and measurements for biceps tenodesis. Am J Sports Med. 2013 Jun;41(6):1395-9. doi: 10.1177/0363546513482297. Epub 2013 Apr 5.
- Background: PubMed 29354407Tao MA, Calcei JG, Taylor SA. Biceps Tenodesis: Anatomic Tensioning. Arthrosc Tech. 2017 Jul 24;6(4):e1125-e1129. doi: 10.1016/j.eats.2017.03.033. eCollection 2017 Aug.
- Background: PubMed 15689867Wolf RS, Zheng N, Weichel D. Long head biceps tenotomy versus tenodesis: a cadaveric biomechanical analysis. Arthroscopy. 2005 Feb;21(2):182-5. doi: 10.1016/j.arthro.2004.10.014.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomic Long Head of Biceps Tensioning Technique and Traditional Long Head of Biceps Tensioning Technique in people with Biceps Tendon Disorder and Tendinosis, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06571695, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.