NCT01747902

Brief Summary

The long head of biceps brachii tendon has been known to be a pain generator and a common cause of shoulder pain and dysfunction in patients with rotator cuff pathology. Both biceps tenotomy and tenodesis have been shown to produce comparable results, but there is no consensus to date due to a lack of level I evidence. The aim of this prospective, randomized, clinical trial is to compare subjective patient-reported outcomes and objective clinical results between biceps tenotomy and biceps tenodesis for treating lesions of the long head of the biceps brachii.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

5.2 years

First QC Date

December 5, 2012

Last Update Submit

September 15, 2020

Conditions

Rotator Cuff TearLong Head of Biceps Brachii Lesions

Outcome Measures

Primary Outcomes (1)

  • American Should and Elbow Society (ASES)

    24 months

Secondary Outcomes (6)

  • Operative Time

    24 months

  • Incidence of Revision

    24 months

  • Complications

    24 months

  • Magnetic Resonance Imaging (MRI)

    24 months

  • Strength

    24 months

  • +1 more secondary outcomes

Study Arms (2)

Biceps tenodesis

OTHER

The biceps tenodesis group will have their bicep detached and then re-inserted onto the shoulder.

Procedure: Biceps Tenodesis

Biceps Tenotomy

OTHER

The biceps tenotomy group will have their bicep treated by detaching the tendon from the shoulder.

Procedure: Biceps Tenotomy

Interventions

Biceps TenotomyPROCEDURE

The biceps tenotomy group will have their bicep treated by detaching the tendon from the shoulder.

Biceps Tenotomy
Biceps TenodesisPROCEDURE

The biceps tenodesis group will have their bicep detached and then re-inserted onto the shoulder.

Biceps tenodesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Must benefit from arthroscopic rotator cuff surgery and inta-operative findings must confirm a lesion of the long head of biceps tendon

You may not qualify if:

  • Any significant comorbidities including previous surgery on affected shoulder
  • Active worker's compensation claims
  • Active joint or systemic infection, significant muscle paralysis, Charcot's arthropathy
  • Significant medical comorbidity that could alter the effectiveness of the surgical intervention (e.g., Cervical radiculopathy, polymyalgia rheumatica)
  • Major medical illness (life expectancy less then one year or unacceptably high operative risk)
  • Inability to speak or read English/French
  • Psychiatric illness that precludes informed consent
  • Unwillingness to be followed for 2 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

Related Publications (17)

  • Friedman DJ, Dunn JC, Higgins LD, Warner JJ. Proximal biceps tendon: injuries and management. Sports Med Arthrosc Rev. 2008 Sep;16(3):162-9. doi: 10.1097/JSA.0b013e318184f549.

    PMID: 18703976BACKGROUND

  • Szabo I, Boileau P, Walch G. The proximal biceps as a pain generator and results of tenotomy. Sports Med Arthrosc Rev. 2008 Sep;16(3):180-6. doi: 10.1097/JSA.0b013e3181824f1e.

    PMID: 18703979BACKGROUND

  • Frost A, Zafar MS, Maffulli N. Tenotomy versus tenodesis in the management of pathologic lesions of the tendon of the long head of the biceps brachii. Am J Sports Med. 2009 Apr;37(4):828-33. doi: 10.1177/0363546508322179. Epub 2008 Sep 1.

    PMID: 18762669BACKGROUND

  • 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: 20551285BACKGROUND

  • Kelly AM, Drakos MC, Fealy S, Taylor SA, O'Brien SJ. Arthroscopic release of the long head of the biceps tendon: functional outcome and clinical results. Am J Sports Med. 2005 Feb;33(2):208-13. doi: 10.1177/0363546504269555.

    PMID: 15701606BACKGROUND

  • Boileau P, Krishnan SG, Coste JS, Walch G. Arthroscopic biceps tenodesis: a new technique using bioabsorbable interference screw fixation. Arthroscopy. 2002 Nov-Dec;18(9):1002-12. doi: 10.1053/jars.2002.36488.

    PMID: 12426544BACKGROUND

  • 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: 15889020BACKGROUND

  • Boileau P, Baque F, Valerio L, Ahrens P, Chuinard C, Trojani C. Isolated arthroscopic biceps tenotomy or tenodesis improves symptoms in patients with massive irreparable rotator cuff tears. J Bone Joint Surg Am. 2007 Apr;89(4):747-57. doi: 10.2106/JBJS.E.01097.

    PMID: 17403796BACKGROUND

  • Edwards TB, Walch G, Sirveaux F, Mole D, Nove-Josserand L, Boulahia A, Neyton L, Szabo I, Lindgren B, O'Connor DP. Repair of tears of the subscapularis. Surgical technique. J Bone Joint Surg Am. 2006 Mar;88 Suppl 1 Pt 1:1-10. doi: 10.2106/JBJS.E.00842.

    PMID: 16510795BACKGROUND

  • Osbahr DC, Diamond AB, Speer KP. The cosmetic appearance of the biceps muscle after long-head tenotomy versus tenodesis. Arthroscopy. 2002 May-Jun;18(5):483-7. doi: 10.1053/jars.2002.32233.

    PMID: 11987057BACKGROUND

  • Slenker NR, Lawson K, Ciccotti MG, Dodson CC, Cohen SB. Biceps tenotomy versus tenodesis: clinical outcomes. Arthroscopy. 2012 Apr;28(4):576-82. doi: 10.1016/j.arthro.2011.10.017. Epub 2012 Jan 28.

    PMID: 22284407BACKGROUND

  • Duff SJ, Campbell PT. Patient acceptance of long head of biceps brachii tenotomy. J Shoulder Elbow Surg. 2012 Jan;21(1):61-5. doi: 10.1016/j.jse.2011.01.014. Epub 2011 Mar 30.

    PMID: 21454097BACKGROUND

  • 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: 15689867BACKGROUND

  • Shank JR, Singleton SB, Braun S, Kissenberth MJ, Ramappa A, Ellis H, Decker MJ, Hawkins RJ, Torry MR. A comparison of forearm supination and elbow flexion strength in patients with long head of the biceps tenotomy or tenodesis. Arthroscopy. 2011 Jan;27(1):9-16. doi: 10.1016/j.arthro.2010.06.022. Epub 2010 Oct 29.

    PMID: 21035992BACKGROUND

  • Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13.

    PMID: 22958838BACKGROUND

  • Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002 Nov-Dec;11(6):587-94. doi: 10.1067/mse.2002.127096.

    PMID: 12469084BACKGROUND

  • MacDonald P, Verhulst F, McRae S, Old J, Stranges G, Dubberley J, Mascarenhas R, Koenig J, Leiter J, Nassar M, Lapner P. Biceps Tenodesis Versus Tenotomy in the Treatment of Lesions of the Long Head of the Biceps Tendon in Patients Undergoing Arthroscopic Shoulder Surgery: A Prospective Double-Blinded Randomized Controlled Trial. Am J Sports Med. 2020 May;48(6):1439-1449. doi: 10.1177/0363546520912212. Epub 2020 Mar 30.

    PMID: 32223645DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Peter MacDonald, MD FRCSC

    Pan Am Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Head, Orthopaedics

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 12, 2012

Study Start

January 1, 2013

Primary Completion

April 1, 2018

Study Completion

May 1, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

CA(1)