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

NCT ID: NCT06571695

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-27
• Study Completion Date: 2024-02-20

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.

Conditions

Biceps Tendon Disorder; Tendinosis; Rotator Cuff Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Anatomic Long Head of Biceps Tensioning Technique

Intervention Type: PROCEDURE

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.

Group Type: ACTIVE_COMPARATOR

Traditional Long Head of Biceps Tensioning Technique

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Dane Salazar

Vice Chair and Professor of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23766967 (View on PubMed)

Denard 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.

Reference Type: BACKGROUND

PMID: 22925883 (View on PubMed)

Hussain 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.

Reference Type: BACKGROUND

PMID: 24573238 (View on PubMed)

Jarrett 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.

Reference Type: BACKGROUND

PMID: 20943419 (View on PubMed)

Lafrance 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.

Reference Type: BACKGROUND

PMID: 23562807 (View on PubMed)

Tao 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.

Reference Type: BACKGROUND

PMID: 29354407 (View on PubMed)

Wolf 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.

Reference Type: BACKGROUND

PMID: 15689867 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

212671

Identifier Type: -

Identifier Source: org_study_id