Biceps Tendon DisorderNCT04650477
Forearm Position in Subpectoral Biceps Tenodesis
A study testing Fixation while forearm in extension-pronation position in people with Biceps Tendon Disorder, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Biceps Tendon Disorder
- What is being tested?
- Fixation while forearm in extension-pronation position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2013to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Participants with diagnosis of chronic biceps tendinitis
Who cannot join
- Participants who had undergone rotator cuff repair surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Prof. Cemil Tascioglu City Hospital
Istanbul
About this study
Official title: Does Forearm Position Matter in Subpectoral Biceps Tenodesis? A Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Biceps Tendon Disorder
- Being tested
- Fixation while forearm in extension-pronation position
- Keywords
- biceps, tenodesis, forearm, shoulder arthroscopy, position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixation while forearm in extension-pronation positionProcedure or surgery
Fixation was performed after tenodesis in the extension-pronation position, which is the anatomically most suitable position of the biceps tendon.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Feb 2013
- Primary completionJan 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Biceps Tendon DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulent KARSLIOGLU, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Bulent Karslıoğlu, Study chair, SBU Prof Cemil Tascioglu City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650477
- Sponsor's protocol ID
- Forearm position in tenodesis
- Status last verified
- Dec 2020
- First submitted
- 9 Nov 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17785735Alpantaki 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.
PubMed 15995126Arena 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.
PubMed 29399446Baker 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.
PubMed 3972865Ball 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. doi: 10.1053/jars.2002.36488.
PubMed 12426544Boileau 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.
PubMed 16369756Eames 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.
PubMed 17473142Fellows 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.
PubMed 3656128Fogg 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.
PubMed 19280656Forman 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.
PubMed 31116661Gill 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.
PubMed 11408906Itoi 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.
PubMed 8331107Jarrett 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.
PubMed 21813298Kilicoglu 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.
PubMed 16009989
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Forearm Position Matter in Subpectoral Biceps Tenodesis? A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04650477
- Acronym / sponsor ID
- Forearm position in tenodesis
- Conditions
- Biceps Tendon Disorder
- Keywords
- biceps, tenodesis, forearm, shoulder arthroscopy, position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixated in the EP position | Active comparator | Procedure: Fixation while forearm in extension-pronation positionLong head of biceps tenodesis was performed for 25 patients whose joints were fixated while forearm in the extension-pronation (EP) 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Participants with diagnosis of chronic biceps tendinitis
Key exclusion criteria (1 listed)
- Participants who had undergone rotator cuff repair surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixation while forearm in extension-pronation positionFixation was performed after tenodesis in the extension-pronation position, which is the anatomically most suitable position of the biceps tendon. | Procedure or surgery | Fixated in the EP position |
Primary outcome
Comparison of the two groups in terms of functional score
Time frame: 6 months
The investigators evaluated the functional results of the patients with the Ases score. 100 points is the best result in 17 questions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Background: PubMed 17785735Ahrens 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.
- Background: PubMed 15995126Alpantaki 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.
- Background: PubMed 29399446Arena 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.
- Background: PubMed 3972865Baker 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.
- BackgroundBall 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: PubMed 12426544Boileau 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.
- Background: PubMed 16369756Boileau 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.
- Background: PubMed 17473142Eames 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.
- Background: PubMed 3656128Fellows 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.
- Background: PubMed 19280656Fogg 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.
- Background: PubMed 31116661Forman 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.
- Background: PubMed 11408906Gill 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bulent Karslıoğlu study chair
SBU Prof Cemil Tascioglu City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixation while forearm in extension-pronation position in people with Biceps Tendon Disorder, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the two groups in terms of functional score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04650477, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.