Bicep TendinitisNCT03529162
A Prospective Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis
A study testing Long head of Biceps Tenodesis in people with Bicep Tendinitis and Biceps; Tenosynovitis, run by St. Louis University at 3 sites in United States.
Trial summary
This is a prospective randomized controlled trial comparing two common techniques of long head of biceps tendon tenodesis in shoulder surgery. Numerous techniques of biceps tenodesis currently exist and are commonly performed. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Bicep Tendinitis, Biceps; Tenosynovitis, Biceps Tendon Disorder
- What is being tested?
- Long head of Biceps Tenodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Oct 2018to 27 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 - 100 years
- Able to provide written informed consent
- Has: (a) partial- or full-thickness rotator cuff tear verified by preoperative magnetic resonance imaging (MRI) and arthroscopy; (b) concomitant biceps lesions (LHBT partial tear>50%, SLAP type II lesion, pulley lesion, or subluxation/dislocation of LHBT) that were diagnosed arthroscopically with concomitant symptoms; and (c) arthroscopic rotator cuff repair.
Who cannot join
- Any medical illness that adversely impacts the patient's ability to complete the study procedures
- Isolated glenohumeral pathological conditions
- Any prior surgery on the same shoulder
- Complete rupture of the LHBT assessed by MRI or at time of procedure
- Incomplete repair of the rotator cuff
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Saint Louis University
St Louis, Missouri, 63110
SSM Health - Saint Louis University Hospital
St Louis, Missouri, 63110
SSM Health - St. Mary's Hospital
St Louis, Missouri, 63110
About this study
Official title: A Prospective Randomized Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis
This is a prospective randomized controlled trial comparing two common techniques of long head of biceps tendon tenodesis in shoulder surgery. Numerous techniques of biceps tenodesis currently exist and are commonly performed. We will be comparing the tenodesis procedure using a suture anchor device versus a technique where the tendon is simply sutured to the pectoralis major tendon.
Read the detailed description
Biceps tenodesis is a commonly performed procedure in shoulder surgery. In many cases, it is performed in conjunction with a rotator cuff repair. Currently, biceps tenodesis is performed in many different ways depending on surgeon preference. First, the location of the tenodesis can vary, as surgeons may prefer a suprapectoral or subpectoral tenodesis location. In addition, the tenodesis fixation technique can also vary, as surgeons have the option to use a screw or suture anchor to perform the tenodesis. There have been numerous studies comparing these various techniques, including suprapectoral versus subpectoral techniques and screw versus suture anchor techniques. None of these studies have been conclusive, and there continues to be controversy as to the best technique.
The current study will compare two techniques of subpectoral biceps tenodesis. Specifically, we will compare tenodesis using a suture anchor versus a technique where the tendon is simply sutured to the pectoralis major tendon. The latter technique has been previously described and published.
- Being tested
- Long head of Biceps Tenodesis
- Keywords
- Biceps Tendinitis, Subpectoral biceps tenodesis, Biceps tendon disorder
- Medical subject headings
- Tenosynovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long head of Biceps TenodesisProcedure or surgery
Patients will be randomized into two different groups to compare biceps tenodesis techniques
| Study group | Role | What they receive |
|---|---|---|
| Suture Anchor Technique (SA) | Active comparator | If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor. Receives: Procedure: Long head of Biceps Tenodesis |
| Pectoralis Major Technique (PMT) | Active comparator | If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon. Receives: Procedure: Long head of Biceps Tenodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Long Head of the Biceps Tendon Score (LHB)
The LHB score is a composite endpoint (maximum 100 points) that evaluates 'biceps pain and muscle cramps', 'cosmesis', and 'flexion strength at the elbow'. It is an outcome score specific for biceps tendon pathology. The score range is 0-100, with a higher score representing better function. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
Measured: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
Secondary outcomes (4)
Change in Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. "0" is no pain and "10" is the worst pain. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
Measured: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
Change in Disabilities of the Arm, Shoulder, and Hand Score (DASH)
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
Measured: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
Change in Single Assessment Numeric Evaluation (SANE)
The Single Assessment Numeric Evaluation (SANE) is a simple, one-question patient-reported outcome measure (PROM). Scoring is 1 to 100, with 100 being the highest function/no pain score. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
Measured: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
Change in American Shoulder and Elbow Surgeons (ASES) Shoulder Score
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology regardless of their specific diagnosis.
The ASES score contains a physician-rated and patient-rated section; however, only the pain visual analog scale (VAS) and 10 functional questions are typically used to tabulate the reported ASES score. The total score - 100 maximum points - is weighted 50% for pain and 50% for function. A score of 100 represents a better outcome and a score of 0 represents a worse outcome. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
Measured: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start19 Oct 2018
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Why it stopped: COVID-19, followed by PI leaving institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Bicep TendinitisStudies 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
- Model description
- Prospective Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard M Place, St. Louis University
- Investigators
- Christopher Kim, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529162
- Sponsor's protocol ID
- 29091
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2018
- Last updated
- 29 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Abbot AE, Li X, Busconi BD. Arthroscopic treatment of concomitant superior labral anterior posterior (SLAP) lesions and rotator cuff tears in patients over the age of 45 years. Am J Sports Med. 2009 Jul;37(7):1358-62. doi: 10.1177/0363546509331940. Epub 2009 Apr 13.
PubMed 19364887Ahmed M, Young BT, Bledsoe G, Cutuk A, Kaar SG. Biomechanical comparison of long head of biceps tenodesis with interference screw and biceps sling soft tissue techniques. Arthroscopy. 2013 Jul;29(7):1157-63. doi: 10.1016/j.arthro.2013.04.001. Epub 2013 May 29.
PubMed 23725678Chen CH, Hsu KY, Chen WJ, Shih CH. Incidence and severity of biceps long head tendon lesion in patients with complete rotator cuff tears. J Trauma. 2005 Jun;58(6):1189-93. doi: 10.1097/01.ta.0000170052.84544.34.
PubMed 15995469Chung SW, Oh JH, Gong HS, Kim JY, Kim SH. Factors affecting rotator cuff healing after arthroscopic repair: osteoporosis as one of the independent risk factors. Am J Sports Med. 2011 Oct;39(10):2099-107. doi: 10.1177/0363546511415659. Epub 2011 Aug 3.
PubMed 21813440Golish SR, Caldwell PE 3rd, Miller MD, Singanamala N, Ranawat AS, Treme G, Pearson SE, Costic R, Sekiya JK. Interference screw versus suture anchor fixation for subpectoral tenodesis of the proximal biceps tendon: a cadaveric study. Arthroscopy. 2008 Oct;24(10):1103-8. doi: 10.1016/j.arthro.2008.05.005. Epub 2008 Jun 16.
PubMed 19028161Habermeyer P, Magosch P, Pritsch M, Scheibel MT, Lichtenberg S. Anterosuperior impingement of the shoulder as a result of pulley lesions: a prospective arthroscopic study. J Shoulder Elbow Surg. 2004 Jan-Feb;13(1):5-12. doi: 10.1016/j.jse.2003.09.013.
PubMed 14735066Hsu AR, Ghodadra NS, Provencher MT, Lewis PB, Bach BR. Biceps tenotomy versus tenodesis: a review of clinical outcomes and biomechanical results. J Shoulder Elbow Surg. 2011 Mar;20(2):326-32. doi: 10.1016/j.jse.2010.08.019. Epub 2010 Nov 4.
PubMed 21051241Koh 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.
PubMed 20551285Oh JH, Kim SH, Ji HM, Jo KH, Bin SW, Gong HS. Prognostic factors affecting anatomic outcome of rotator cuff repair and correlation with functional outcome. Arthroscopy. 2009 Jan;25(1):30-9. doi: 10.1016/j.arthro.2008.08.010. Epub 2008 Oct 10.
PubMed 19111216Oh JH, Lee YH, Kim SH, Park JS, Seo HJ, Kim W, Park HB. Comparison of Treatments for Superior Labrum-Biceps Complex Lesions With Concomitant Rotator Cuff Repair: A Prospective, Randomized, Comparative Analysis of Debridement, Biceps Tenotomy, and Biceps Tenodesis. Arthroscopy. 2016 Jun;32(6):958-67. doi: 10.1016/j.arthro.2015.11.036. Epub 2016 Feb 23.
PubMed 26921128Park JS, Kim SH, Jung HJ, Lee YH, Oh JH. A Prospective Randomized Study Comparing the Interference Screw and Suture Anchor Techniques for Biceps Tenodesis. Am J Sports Med. 2017 Feb;45(2):440-448. doi: 10.1177/0363546516667577. Epub 2016 Oct 22.
PubMed 28146397Pogorzelski J, Horan MP, Hussain ZB, Vap A, Fritz EM, Millett PJ. Subpectoral Biceps Tenodesis for Treatment of Isolated Type II SLAP Lesions in a Young and Active Population. Arthroscopy. 2018 Feb;34(2):371-376. doi: 10.1016/j.arthro.2017.07.021. Epub 2017 Sep 9.
PubMed 28899638Ramos CH, Coelho JC. Biomechanical evaluation of the long head of the biceps brachii tendon fixed by three techniques: a sheep model. Rev Bras Ortop. 2016 Dec 30;52(1):52-60. doi: 10.1016/j.rboe.2016.12.008. eCollection 2017 Jan-Feb.
PubMed 28194382Scheibel M, Schroder RJ, Chen J, Bartsch M. Arthroscopic soft tissue tenodesis versus bony fixation anchor tenodesis of the long head of the biceps tendon. Am J Sports Med. 2011 May;39(5):1046-52. doi: 10.1177/0363546510390777. Epub 2011 Jan 21.
PubMed 21257843Walch 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.
PubMed 15889020
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis
- ClinicalTrials.gov ID
- NCT03529162
- Acronym / sponsor ID
- 29091
- Keywords
- Biceps Tendinitis, Subpectoral biceps tenodesis, Biceps tendon disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19, followed by PI leaving institution.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Posted 29 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized controlled trial comparing two common techniques of long head of biceps tendon tenodesis in shoulder surgery. Numerous techniques of biceps tenodesis currently exist and are commonly performed. We will be comparing the tenodesis procedure using a suture anchor device versus a technique where the tendon is simply sutured to the pectoralis major tendon.
Detailed description
Biceps tenodesis is a commonly performed procedure in shoulder surgery. In many cases, it is performed in conjunction with a rotator cuff repair. Currently, biceps tenodesis is performed in many different ways depending on surgeon preference. First, the location of the tenodesis can vary, as surgeons may prefer a suprapectoral or subpectoral tenodesis location. In addition, the tenodesis fixation technique can also vary, as surgeons have the option to use a screw or suture anchor to perform the tenodesis. There have been numerous studies comparing these various techniques, including suprapectoral versus subpectoral techniques and screw versus suture anchor techniques. None of these studies have been conclusive, and there continues to be controversy as to the best technique.
The current study will compare two techniques of subpectoral biceps tenodesis. Specifically, we will compare tenodesis using a suture anchor versus a technique where the tendon is simply sutured to the pectoralis major tendon. The latter technique has been previously described and published.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Suture Anchor Technique (SA) | Active comparator | Procedure: Long head of Biceps TenodesisIf randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor. |
| Pectoralis Major Technique (PMT) | Active comparator | Procedure: Long head of Biceps TenodesisIf randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 - 100 years
- Able to provide written informed consent
- Has: (a) partial- or full-thickness rotator cuff tear verified by preoperative magnetic resonance imaging (MRI) and arthroscopy; (b) concomitant biceps lesions (LHBT partial tear>50%, SLAP type II lesion, pulley lesion, or subluxation/dislocation of LHBT) that were diagnosed arthroscopically with concomitant symptoms; and (c) arthroscopic rotator cuff repair.
Key exclusion criteria (5 listed)
- Any medical illness that adversely impacts the patient's ability to complete the study procedures
- Isolated glenohumeral pathological conditions
- Any prior surgery on the same shoulder
- Complete rupture of the LHBT assessed by MRI or at time of procedure
- Incomplete repair of the rotator cuff
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 |
|---|---|---|
| Long head of Biceps TenodesisPatients will be randomized into two different groups to compare biceps tenodesis techniques | Procedure or surgery | Pectoralis Major Technique (PMT), Suture Anchor Technique (SA) |
Primary outcome
Change in Long Head of the Biceps Tendon Score (LHB)
Time frame: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
The LHB score is a composite endpoint (maximum 100 points) that evaluates 'biceps pain and muscle cramps', 'cosmesis', and 'flexion strength at the elbow'. It is an outcome score specific for biceps tendon pathology. The score range is 0-100, with a higher score representing better function. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
4 secondary outcomes
Change in Visual Analogue Scale (VAS)
Time frame: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
Change in Disabilities of the Arm, Shoulder, and Hand Score (DASH)
Time frame: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
Change in Single Assessment Numeric Evaluation (SANE)
Time frame: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
Change in American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time frame: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19364887Abbot AE, Li X, Busconi BD. Arthroscopic treatment of concomitant superior labral anterior posterior (SLAP) lesions and rotator cuff tears in patients over the age of 45 years. Am J Sports Med. 2009 Jul;37(7):1358-62. doi: 10.1177/0363546509331940. Epub 2009 Apr 13.
- Background: PubMed 23725678Ahmed M, Young BT, Bledsoe G, Cutuk A, Kaar SG. Biomechanical comparison of long head of biceps tenodesis with interference screw and biceps sling soft tissue techniques. Arthroscopy. 2013 Jul;29(7):1157-63. doi: 10.1016/j.arthro.2013.04.001. Epub 2013 May 29.
- Background: PubMed 15995469Chen CH, Hsu KY, Chen WJ, Shih CH. Incidence and severity of biceps long head tendon lesion in patients with complete rotator cuff tears. J Trauma. 2005 Jun;58(6):1189-93. doi: 10.1097/01.ta.0000170052.84544.34.
- Background: PubMed 21813440Chung SW, Oh JH, Gong HS, Kim JY, Kim SH. Factors affecting rotator cuff healing after arthroscopic repair: osteoporosis as one of the independent risk factors. Am J Sports Med. 2011 Oct;39(10):2099-107. doi: 10.1177/0363546511415659. Epub 2011 Aug 3.
- Background: PubMed 19028161Golish SR, Caldwell PE 3rd, Miller MD, Singanamala N, Ranawat AS, Treme G, Pearson SE, Costic R, Sekiya JK. Interference screw versus suture anchor fixation for subpectoral tenodesis of the proximal biceps tendon: a cadaveric study. Arthroscopy. 2008 Oct;24(10):1103-8. doi: 10.1016/j.arthro.2008.05.005. Epub 2008 Jun 16.
- Background: PubMed 14735066Habermeyer P, Magosch P, Pritsch M, Scheibel MT, Lichtenberg S. Anterosuperior impingement of the shoulder as a result of pulley lesions: a prospective arthroscopic study. J Shoulder Elbow Surg. 2004 Jan-Feb;13(1):5-12. doi: 10.1016/j.jse.2003.09.013.
- Background: PubMed 21051241Hsu AR, Ghodadra NS, Provencher MT, Lewis PB, Bach BR. Biceps tenotomy versus tenodesis: a review of clinical outcomes and biomechanical results. J Shoulder Elbow Surg. 2011 Mar;20(2):326-32. doi: 10.1016/j.jse.2010.08.019. Epub 2010 Nov 4.
- Background: PubMed 20551285Koh 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.
- Background: PubMed 19111216Oh JH, Kim SH, Ji HM, Jo KH, Bin SW, Gong HS. Prognostic factors affecting anatomic outcome of rotator cuff repair and correlation with functional outcome. Arthroscopy. 2009 Jan;25(1):30-9. doi: 10.1016/j.arthro.2008.08.010. Epub 2008 Oct 10.
- Background: PubMed 26921128Oh JH, Lee YH, Kim SH, Park JS, Seo HJ, Kim W, Park HB. Comparison of Treatments for Superior Labrum-Biceps Complex Lesions With Concomitant Rotator Cuff Repair: A Prospective, Randomized, Comparative Analysis of Debridement, Biceps Tenotomy, and Biceps Tenodesis. Arthroscopy. 2016 Jun;32(6):958-67. doi: 10.1016/j.arthro.2015.11.036. Epub 2016 Feb 23.
- Background: PubMed 28146397Park JS, Kim SH, Jung HJ, Lee YH, Oh JH. A Prospective Randomized Study Comparing the Interference Screw and Suture Anchor Techniques for Biceps Tenodesis. Am J Sports Med. 2017 Feb;45(2):440-448. doi: 10.1177/0363546516667577. Epub 2016 Oct 22.
- Background: PubMed 28899638Pogorzelski J, Horan MP, Hussain ZB, Vap A, Fritz EM, Millett PJ. Subpectoral Biceps Tenodesis for Treatment of Isolated Type II SLAP Lesions in a Young and Active Population. Arthroscopy. 2018 Feb;34(2):371-376. doi: 10.1016/j.arthro.2017.07.021. Epub 2017 Sep 9.
- Individual participant dataSharing planned: No
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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.
Christopher Kim, MD principal investigator
St. Louis University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long head of Biceps Tenodesis in people with Bicep Tendinitis and Biceps; Tenosynovitis, run by St. Louis University at 3 sites in United States.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Long Head of the Biceps Tendon Score (LHB) (time frame: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.). 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 NCT03529162, which also lists 16 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 29 Apr 2021.