search
Back to results

Forearm Position in Subpectoral Biceps Tenodesis

Primary Purpose

Biceps Tendon Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fixation while forearm in extension-pronation position
Sponsored by
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biceps Tendon Disorder focused on measuring biceps, tenodesis, forearm, shoulder arthroscopy, position

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Participants with diagnosis of chronic biceps tendinitis

Exclusion Criteria:

- Participants who had undergone rotator cuff repair surgery

Sites / Locations

  • SBU Prof. Cemil Tascioglu City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Fixated in the EP position

Fixated in the neutral position

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2020
Last Updated
December 1, 2020
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
search

1. Study Identification

Unique Protocol Identification Number
NCT04650477
Brief Title
Forearm Position in Subpectoral Biceps Tenodesis
Official Title
Does Forearm Position Matter in Subpectoral Biceps Tenodesis? A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
November 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biceps Tendon Disorder
Keywords
biceps, tenodesis, forearm, shoulder arthroscopy, position

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fixated in the EP position
Arm Type
Active Comparator
Arm Description
Long head of biceps tenodesis was performed for 25 patients whose joints were fixated while forearm in the extension-pronation (EP) position
Arm Title
Fixated in the neutral position
Arm Type
No Intervention
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Fixation while forearm in extension-pronation position
Intervention Description
Fixation was performed after tenodesis in the extension-pronation position, which is the anatomically most suitable position of the biceps tendon.
Primary Outcome Measure Information:
Title
Comparison of the two groups in terms of functional score
Description
The investigators evaluated the functional results of the patients with the Ases score. 100 points is the best result in 17 questions.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Participants with diagnosis of chronic biceps tendinitis Exclusion Criteria: - Participants who had undergone rotator cuff repair surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bulent Karslıoğlu
Organizational Affiliation
SBU Prof Cemil Tascioglu City Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
SBU Prof. Cemil Tascioglu City Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
17785735
Citation
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.
Results Reference
background
PubMed Identifier
15995126
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. doi: 10.2106/JBJS.D.02840.
Results Reference
background
PubMed Identifier
29399446
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.
Results Reference
background
PubMed Identifier
3972865
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
12426544
Citation
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.
Results Reference
background
PubMed Identifier
16369756
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. doi: 10.1007/s00064-005-1154-y. English, German.
Results Reference
background
PubMed Identifier
17473142
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. doi: 10.2106/JBJS.D.02992.
Results Reference
background
PubMed Identifier
3656128
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. doi: 10.1113/jphysiol.1987.sp016416.
Results Reference
background
PubMed Identifier
19280656
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.
Results Reference
background
PubMed Identifier
31116661
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.
Results Reference
background
PubMed Identifier
11408906
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. doi: 10.1067/mse.2001.114259.
Results Reference
background
PubMed Identifier
8331107
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. doi: 10.1302/0301-620X.75B4.8331107. Erratum In: J Bone Joint Surg Br 1994 Jan;76(1):170.
Results Reference
background
PubMed Identifier
21813298
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.
Results Reference
background
PubMed Identifier
16009989
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. doi: 10.1177/0363546505274716. Epub 2005 Jul 11.
Results Reference
background
PubMed Identifier
2743659
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
14716285
Citation
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.
Results Reference
background
PubMed Identifier
16158544
Citation
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.
Results Reference
background
PubMed Identifier
29500072
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.
Results Reference
background
PubMed Identifier
10543593
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. doi: 10.1016/s1058-2746(99)90070-8.
Results Reference
background

Learn more about this trial

Forearm Position in Subpectoral Biceps Tenodesis

We'll reach out to this number within 24 hrs