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

NCT06571695 | Completed Results

• 1 other identifier: 212671
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Biceps Tendon Disorder; Tendinosis; Rotator Cuff Injuries

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  1.5 years

Secondary Outcomes (13)

• Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups

  6 weeks

• Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups

  3 months

• Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups

  6 months

• Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups

  1 year

• Comparison of Visual Analog Scale (VAS) Pain Score Between Treatment and Control Groups

  1.5 years

Study Arms (2)

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.

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.

Procedure: Traditional Long Head of Biceps Tensioning Technique

Interventions

Anatomic Long Head of Biceps Tensioning Technique 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

Anatomic Long Head of Biceps Tensioning Technique

Traditional Long Head of Biceps Tensioning Technique 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

Traditional Long Head of Biceps Tensioning Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (7)

• 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.

  PMID: 23766967 BACKGROUND

• 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.

  PMID: 22925883 BACKGROUND

• 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.

  PMID: 24573238 BACKGROUND

• 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.

  PMID: 20943419 BACKGROUND

• 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.

  PMID: 23562807 BACKGROUND

• 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.

  PMID: 29354407 BACKGROUND

• 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.

  PMID: 15689867 BACKGROUND

MeSH Terms

Conditions

Tendinopathy; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Rupture; Shoulder Injuries

Limitations and Caveats

The rate of response to pain, functional outcomes, and range of motion was low at most of the follow-up timepoints

Results Point of Contact

• Title: Dr. Dane H. Salazar
• Organization: Loyola University Medical Center

dsalazar@lumc.edu

773-562-0456

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair and Professor of Orthopaedic Surgery

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

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: October 27, 2020
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)