Forearm Position in Subpectoral Biceps Tenodesis

Biceps Tendon Disorder Clinical Trial

Official title:

Does Forearm Position Matter in Subpectoral Biceps Tenodesis? A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04650477
• Other study ID #: Forearm position in tenodesis
• Status: Completed
• Phase: N/A
• Start date: February 1, 2013
• Est. completion date: November 2020

Study information

• Verified date: December 2020
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Long head of biceps pathologies have been regarded as a source of anterior shoulder pain and disability. Tenodesis is preferable surgical choice for especially young patients to to eliminate anterior shoulder pain. The optimal position of the elbow and forearm during tenodesis is a debated topic. The investigators aimed to evaluate pain and strength loss after biceps tenodesis fixed at extension-pronation (EP) and neutral positions. The investigators aimed to find the most appropriate and anatomical arm position that gives better clinical and functional results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

-Participants with diagnosis of chronic biceps tendinitis

Exclusion Criteria:

• Participants who had undergone rotator cuff repair surgery

Related Conditions & MeSH terms

• Biceps Tendon Disorder
• Tendinopathy

Intervention

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

Locations

Country	Name	City	State
Turkey	SBU Prof. Cemil Tascioglu City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Boileau P, Neyton L. Arthroscopic tenodesis for lesions of the long head of the biceps. Oper Orthop Traumatol. 2005 Dec;17(6):601-23. English, German. — View Citation

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. — View Citation

Fellows SJ, Rack PM. Changes in the length of the human biceps brachii muscle during elbow movements. J Physiol. 1987 Feb;383:405-12. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: J Bone Joint Surg Br 1994 Jan;76(1):170. — View Citation

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. — View Citation

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. Epub 2005 Jul 11. — View Citation

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. — View Citation

Lo IK, Burkhart SS. Arthroscopic biceps tenodesis using a bioabsorbable interference screw. Arthroscopy. 2004 Jan;20(1):85-95. — View Citation

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

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. French. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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