Clinical trial NCT06571695: Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis
Official title: Long Head of the Biceps Subpectoral Tenodesis Anatomic vs. Traditional Tensioning Technique During Rotator Cuff Repair: A Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biceps Tendon Disorder
Tendinosis
Rotator Cuff Injuries
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Anatomic Long Head of Biceps Tensioning Treatment Group vs. Traditional Long Head of Biceps Tensioning Control Group
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
timeFrame: 6 weeks
measure: Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
timeFrame: 3 months
measure: Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
timeFrame: 6 months
measure: Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
timeFrame: 1 year
measure: Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups
timeFrame: 1.5 years
Secondary outcomes:
measure: Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
timeFrame: 6 weeks
measure: Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
timeFrame: 3 months
measure: Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
timeFrame: 6 months
measure: Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
timeFrame: 1 year
measure: Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups
timeFrame: 1.5 years
measure: Comparison of Active Forward Flexion Between Treatment and Control Groups
timeFrame: 6 weeks
measure: Comparison of Active Forward Flexion Between Treatment and Control Groups
timeFrame: 3 months
measure: Comparison of Active Forward Flexion Between Treatment and Control Groups
timeFrame: 6 months
measure: Comparison of Active Forward Flexion Between Treatment and Control Groups
timeFrame: 1 year
measure: Comparison of Active External Rotation Between Treatment and Control Groups
timeFrame: 6 weeks
measure: Comparison of Active External Rotation Between Treatment and Control Groups
timeFrame: 3 months
measure: Comparison of Active External Rotation Between Treatment and Control Groups
timeFrame: 6 months
measure: Comparison of Active External Rotation Between Treatment and Control Groups
timeFrame: 1 year
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.