NCT04650477

Brief Summary

The investigators aimed to compare two different forearm positions, extension-pronation (EP) or neutral, for fixation of the long head of the biceps tendon (LHB) in biceps tenodesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

Study Start

First participant enrolled

February 1, 2013

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
Last Updated

December 2, 2020

Status Verified

December 1, 2020

Enrollment Period

6.9 years

First QC Date

November 9, 2020

Last Update Submit

December 1, 2020

Conditions

Biceps Tendon Disorder

Keywords

bicepstenodesisforearmshoulder arthroscopyposition

Outcome Measures

Primary Outcomes (1)

  • Comparison of the two groups in terms of functional score

    The investigators evaluated the functional results of the patients with the Ases score. 100 points is the best result in 17 questions.

    6 months

Study Arms (2)

Fixated in the EP position

ACTIVE COMPARATOR

Long head of biceps tenodesis was performed for 25 patients whose joints were fixated while forearm in the extension-pronation (EP) position

Procedure: Fixation while forearm in extension-pronation position

Fixated in the neutral position

NO INTERVENTION

Long head of biceps tenodesis was performed for 25 patients whose joints were fixated while forearm in the neutral position (elbow 90 degrees flexed and hands positioned with the thump pointing up

Interventions

Fixation while forearm in extension-pronation positionPROCEDURE

Fixation was performed after tenodesis in the extension-pronation position, which is the anatomically most suitable position of the biceps tendon.

Fixated in the EP position

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with diagnosis of chronic biceps tendinitis

You may not qualify if:

  • \- Participants who had undergone rotator cuff repair surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBU Prof. Cemil Tascioglu City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (21)

  • Ahrens PM, Boileau P. The long head of biceps and associated tendinopathy. J Bone Joint Surg Br. 2007 Aug;89(8):1001-9. doi: 10.1302/0301-620X.89B8.19278.

    PMID: 17785735BACKGROUND

  • Alpantaki K, McLaughlin D, Karagogeos D, Hadjipavlou A, Kontakis G. Sympathetic and sensory neural elements in the tendon of the long head of the biceps. J Bone Joint Surg Am. 2005 Jul;87(7):1580-3. doi: 10.2106/JBJS.D.02840.

    PMID: 15995126BACKGROUND

  • Arena C, Dhawan A. Mini-open Subpectoral Biceps Tenodesis Using a Suture Anchor. Arthrosc Tech. 2017 Sep 18;6(5):e1625-e1631. doi: 10.1016/j.eats.2017.06.019. eCollection 2017 Oct.

    PMID: 29399446BACKGROUND

  • Baker BE, Bierwagen D. Rupture of the distal tendon of the biceps brachii. Operative versus non-operative treatment. J Bone Joint Surg Am. 1985 Mar;67(3):414-7.

    PMID: 3972865BACKGROUND

  • Ball C, Galatz LM, Yamaguchi K. Tenodesis or tenotomy of the biceps tendon: Why and when to do it. Tech Shoulder Elb Surg 2001;2:140-152. doi:10.1097/00132589-200109000-00002

    BACKGROUND

  • 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

  • Boileau P, Neyton L. Arthroscopic tenodesis for lesions of the long head of the biceps. Oper Orthop Traumatol. 2005 Dec;17(6):601-23. doi: 10.1007/s00064-005-1154-y. English, German.

    PMID: 16369756BACKGROUND

  • Eames MH, Bain GI, Fogg QA, van Riet RP. Distal biceps tendon anatomy: a cadaveric study. J Bone Joint Surg Am. 2007 May;89(5):1044-9. doi: 10.2106/JBJS.D.02992.

    PMID: 17473142BACKGROUND

  • Fellows SJ, Rack PM. Changes in the length of the human biceps brachii muscle during elbow movements. J Physiol. 1987 Feb;383:405-12. doi: 10.1113/jphysiol.1987.sp016416.

    PMID: 3656128BACKGROUND

  • Fogg QA, Hess BR, Rodgers KG, Ashwood N. Distal biceps brachii tendon anatomy revisited from a surgical perspective. Clin Anat. 2009 Apr;22(3):346-51. doi: 10.1002/ca.20786.

    PMID: 19280656BACKGROUND

  • Forman DA, Abdel-Malek D, Bunce CMF, Holmes MWR. Muscle length and joint angle influence spinal but not corticospinal excitability to the biceps brachii across forearm postures. J Neurophysiol. 2019 Jul 1;122(1):413-423. doi: 10.1152/jn.00620.2018. Epub 2019 May 22.

    PMID: 31116661BACKGROUND

  • Gill TJ, McIrvin E, Mair SD, Hawkins RJ. Results of biceps tenotomy for treatment of pathology of the long head of the biceps brachii. J Shoulder Elbow Surg. 2001 May-Jun;10(3):247-9. doi: 10.1067/mse.2001.114259.

    PMID: 11408906BACKGROUND

  • Itoi E, Kuechle DK, Newman SR, Morrey BF, An KN. Stabilising function of the biceps in stable and unstable shoulders. J Bone Joint Surg Br. 1993 Jul;75(4):546-50. doi: 10.1302/0301-620X.75B4.8331107.

    PMID: 8331107BACKGROUND

  • Jarrett CD, Weir DM, Stuffmann ES, Jain S, Miller MC, Schmidt CC. Anatomic and biomechanical analysis of the short and long head components of the distal biceps tendon. J Shoulder Elbow Surg. 2012 Jul;21(7):942-8. doi: 10.1016/j.jse.2011.04.030. Epub 2011 Aug 3.

    PMID: 21813298BACKGROUND

  • Kilicoglu O, Koyuncu O, Demirhan M, Esenyel CZ, Atalar AC, Ozsoy S, Bozdag E, Sunbuloglu E, Bilgic B. Time-dependent changes in failure loads of 3 biceps tenodesis techniques: in vivo study in a sheep model. Am J Sports Med. 2005 Oct;33(10):1536-44. doi: 10.1177/0363546505274716. Epub 2005 Jul 11.

    PMID: 16009989BACKGROUND

  • Kumar VP, Satku K, Balasubramaniam P. The role of the long head of biceps brachii in the stabilization of the head of the humerus. Clin Orthop Relat Res. 1989 Jul;(244):172-5.

    PMID: 2743659BACKGROUND

  • Lo IK, Burkhart SS. Arthroscopic biceps tenodesis: Indications and technique. Oper Tech Sports Med 2002;10:105-112. doi:10.1053/otsm.2002.30651

    BACKGROUND

  • Lo IK, Burkhart SS. Arthroscopic biceps tenodesis using a bioabsorbable interference screw. Arthroscopy. 2004 Jan;20(1):85-95. doi: 10.1016/j.arthro.2003.11.017.

    PMID: 14716285BACKGROUND

  • Maynou C, Mehdi N, Cassagnaud X, Audebert S, Mestdagh H. [Clinical results of arthroscopic tenotomy of the long head of the biceps brachii in full thickness tears of the rotator cuff without repair: 40 cases]. Rev Chir Orthop Reparatrice Appar Mot. 2005 Jun;91(4):300-6. doi: 10.1016/s0035-1040(05)84327-2. French.

    PMID: 16158544BACKGROUND

  • Neviaser AS, Patterson DC, Cagle PJ, Parsons BO, Flatow EL. Anatomic landmarks for arthroscopic suprapectoral biceps tenodesis: a cadaveric study. J Shoulder Elbow Surg. 2018 Jul;27(7):1172-1177. doi: 10.1016/j.jse.2018.01.007. Epub 2018 Feb 27.

    PMID: 29500072BACKGROUND

  • Pfahler M, Branner S, Refior HJ. The role of the bicipital groove in tendopathy of the long biceps tendon. J Shoulder Elbow Surg. 1999 Sep-Oct;8(5):419-24. doi: 10.1016/s1058-2746(99)90070-8.

    PMID: 10543593BACKGROUND

Study Officials

  • Bulent Karslıoğlu

    SBU Prof Cemil Tascioglu City Hospital

    STUDY CHAIR

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
Orthopedics and Traumatology specialist,Chief assistant

Study Record Dates

First Submitted

November 9, 2020

First Posted

December 2, 2020

Study Start

February 1, 2013

Primary Completion

January 1, 2020

Study Completion

November 1, 2020

Last Updated

December 2, 2020

Record last verified: 2020-12

Locations

TU(1)