A Prospective Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis

NCT03529162 | Terminated Results FDA Device

• 1 other identifier: 29091
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective randomized controlled trial comparing two common techniques of long head of biceps tendon tenodesis in shoulder surgery. Numerous techniques of biceps tenodesis currently exist and are commonly performed. We will be comparing the tenodesis procedure using a suture anchor device versus a technique where the tendon is simply sutured to the pectoralis major tendon.

Conditions

Bicep Tendinitis; Biceps; Tenosynovitis; Biceps Tendon Disorder

Keywords

Biceps Tendinitis; Subpectoral biceps tenodesis; Biceps tendon disorder

Outcome Measures

Primary Outcomes (1)

• Change in Long Head of the Biceps Tendon Score (LHB)

  The LHB score is a composite endpoint (maximum 100 points) that evaluates 'biceps pain and muscle cramps', 'cosmesis', and 'flexion strength at the elbow'. It is an outcome score specific for biceps tendon pathology. The score range is 0-100, with a higher score representing better function. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.

  This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.

Secondary Outcomes (4)

• Change in Visual Analogue Scale (VAS)

  This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.

• Change in Disabilities of the Arm, Shoulder, and Hand Score (DASH)

  This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.

• Change in Single Assessment Numeric Evaluation (SANE)

  This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.

• Change in American Shoulder and Elbow Surgeons (ASES) Shoulder Score

  This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.

Study Arms (2)

Suture Anchor Technique (SA)

ACTIVE COMPARATOR

If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.

Procedure: Long head of Biceps Tenodesis

Pectoralis Major Technique (PMT)

ACTIVE COMPARATOR

If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.

Procedure: Long head of Biceps Tenodesis

Interventions

Long head of Biceps Tenodesis PROCEDURE

Patients will be randomized into two different groups to compare biceps tenodesis techniques

Pectoralis Major Technique (PMT); Suture Anchor Technique (SA)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 100 years
• Able to provide written informed consent
• Has: (a) partial- or full-thickness rotator cuff tear verified by preoperative magnetic resonance imaging (MRI) and arthroscopy; (b) concomitant biceps lesions (LHBT partial tear\>50%, SLAP type II lesion, pulley lesion, or subluxation/dislocation of LHBT) that were diagnosed arthroscopically with concomitant symptoms; and (c) arthroscopic rotator cuff repair.

You may not qualify if:

• Any medical illness that adversely impacts the patient's ability to complete the study procedures
• Isolated glenohumeral pathological conditions
• Any prior surgery on the same shoulder
• Complete rupture of the LHBT assessed by MRI or at time of procedure
• Incomplete repair of the rotator cuff

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (3)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

SSM Health - Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

SSM Health - St. Mary's Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (16)

• Abbot AE, Li X, Busconi BD. Arthroscopic treatment of concomitant superior labral anterior posterior (SLAP) lesions and rotator cuff tears in patients over the age of 45 years. Am J Sports Med. 2009 Jul;37(7):1358-62. doi: 10.1177/0363546509331940. Epub 2009 Apr 13.

  PMID: 19364887 BACKGROUND

• Ahmed M, Young BT, Bledsoe G, Cutuk A, Kaar SG. Biomechanical comparison of long head of biceps tenodesis with interference screw and biceps sling soft tissue techniques. Arthroscopy. 2013 Jul;29(7):1157-63. doi: 10.1016/j.arthro.2013.04.001. Epub 2013 May 29.

  PMID: 23725678 BACKGROUND

• Chen CH, Hsu KY, Chen WJ, Shih CH. Incidence and severity of biceps long head tendon lesion in patients with complete rotator cuff tears. J Trauma. 2005 Jun;58(6):1189-93. doi: 10.1097/01.ta.0000170052.84544.34.

  PMID: 15995469 BACKGROUND

• Chung SW, Oh JH, Gong HS, Kim JY, Kim SH. Factors affecting rotator cuff healing after arthroscopic repair: osteoporosis as one of the independent risk factors. Am J Sports Med. 2011 Oct;39(10):2099-107. doi: 10.1177/0363546511415659. Epub 2011 Aug 3.

  PMID: 21813440 BACKGROUND

• Golish SR, Caldwell PE 3rd, Miller MD, Singanamala N, Ranawat AS, Treme G, Pearson SE, Costic R, Sekiya JK. Interference screw versus suture anchor fixation for subpectoral tenodesis of the proximal biceps tendon: a cadaveric study. Arthroscopy. 2008 Oct;24(10):1103-8. doi: 10.1016/j.arthro.2008.05.005. Epub 2008 Jun 16.

  PMID: 19028161 BACKGROUND

• Habermeyer P, Magosch P, Pritsch M, Scheibel MT, Lichtenberg S. Anterosuperior impingement of the shoulder as a result of pulley lesions: a prospective arthroscopic study. J Shoulder Elbow Surg. 2004 Jan-Feb;13(1):5-12. doi: 10.1016/j.jse.2003.09.013.

  PMID: 14735066 BACKGROUND

• Hsu AR, Ghodadra NS, Provencher MT, Lewis PB, Bach BR. Biceps tenotomy versus tenodesis: a review of clinical outcomes and biomechanical results. J Shoulder Elbow Surg. 2011 Mar;20(2):326-32. doi: 10.1016/j.jse.2010.08.019. Epub 2010 Nov 4.

  PMID: 21051241 BACKGROUND

• Koh KH, Ahn JH, Kim SM, Yoo JC. Treatment of biceps tendon lesions in the setting of rotator cuff tears: prospective cohort study of tenotomy versus tenodesis. Am J Sports Med. 2010 Aug;38(8):1584-90. doi: 10.1177/0363546510364053. Epub 2010 Jun 15.

  PMID: 20551285 BACKGROUND

• Oh JH, Kim SH, Ji HM, Jo KH, Bin SW, Gong HS. Prognostic factors affecting anatomic outcome of rotator cuff repair and correlation with functional outcome. Arthroscopy. 2009 Jan;25(1):30-9. doi: 10.1016/j.arthro.2008.08.010. Epub 2008 Oct 10.

  PMID: 19111216 BACKGROUND

• Oh JH, Lee YH, Kim SH, Park JS, Seo HJ, Kim W, Park HB. Comparison of Treatments for Superior Labrum-Biceps Complex Lesions With Concomitant Rotator Cuff Repair: A Prospective, Randomized, Comparative Analysis of Debridement, Biceps Tenotomy, and Biceps Tenodesis. Arthroscopy. 2016 Jun;32(6):958-67. doi: 10.1016/j.arthro.2015.11.036. Epub 2016 Feb 23.

  PMID: 26921128 BACKGROUND

• Park JS, Kim SH, Jung HJ, Lee YH, Oh JH. A Prospective Randomized Study Comparing the Interference Screw and Suture Anchor Techniques for Biceps Tenodesis. Am J Sports Med. 2017 Feb;45(2):440-448. doi: 10.1177/0363546516667577. Epub 2016 Oct 22.

  PMID: 28146397 BACKGROUND

• Pogorzelski J, Horan MP, Hussain ZB, Vap A, Fritz EM, Millett PJ. Subpectoral Biceps Tenodesis for Treatment of Isolated Type II SLAP Lesions in a Young and Active Population. Arthroscopy. 2018 Feb;34(2):371-376. doi: 10.1016/j.arthro.2017.07.021. Epub 2017 Sep 9.

  PMID: 28899638 BACKGROUND

• Ramos CH, Coelho JC. Biomechanical evaluation of the long head of the biceps brachii tendon fixed by three techniques: a sheep model. Rev Bras Ortop. 2016 Dec 30;52(1):52-60. doi: 10.1016/j.rboe.2016.12.008. eCollection 2017 Jan-Feb.

  PMID: 28194382 BACKGROUND

• Scheibel M, Schroder RJ, Chen J, Bartsch M. Arthroscopic soft tissue tenodesis versus bony fixation anchor tenodesis of the long head of the biceps tendon. Am J Sports Med. 2011 May;39(5):1046-52. doi: 10.1177/0363546510390777. Epub 2011 Jan 21.

  PMID: 21257843 BACKGROUND

• Walch G, Edwards TB, Boulahia A, Nove-Josserand L, Neyton L, Szabo I. Arthroscopic tenotomy of the long head of the biceps in the treatment of rotator cuff tears: clinical and radiographic results of 307 cases. J Shoulder Elbow Surg. 2005 May-Jun;14(3):238-46. doi: 10.1016/j.jse.2004.07.008.

  PMID: 15889020 BACKGROUND

• Zehnder Sw, Kaar SG, Joy E. Transpectoral Biceps Sling Tenodesis: Surgical Technique. Tech Should Surg. 2011;12: 32-35.

  BACKGROUND

MeSH Terms

Conditions

Tenosynovitis

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Limitations and Caveats

Early termination of study due to COVID-19 and later the departure of PI from institution.

Results Point of Contact

• Title: Sarah Dawson, Research Nurse
• Organization: Saint Louis University

sarah.dawson@health.slu.edu

314-977-4106

Study Officials

• Christopher Kim, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair

Model Details: Prospective Randomized Controlled Trial

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 18, 2018
• Study Start: October 19, 2018
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: April 29, 2021
• Results First Posted: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)