Not provided
Not provided
Not provided
Not provided
Not provided
COVID-19, followed by PI leaving institution.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long head of Biceps Tenodesis | Procedure | Patients will be randomized into two different groups to compare biceps tenodesis techniques |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher Kim, MD | St. Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis University | St Louis | Missouri | 63110 | United States | ||
| SSM Health - Saint Louis University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19364887 | Background | 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. | |
| 23725678 | Background | Ahmed 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pectoralis Major Technique (PMT) | 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. Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 5, 2019 |
Not provided
Not provided
Prospective Randomized Controlled Trial
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported. |
| St Louis |
| Missouri |
| 63110 |
| United States |
| SSM Health - St. Mary's Hospital | St Louis | Missouri | 63110 | United States |
| 15995469 | Background | Chen 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. |
| 21813440 | Background | Chung 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. |
| 19028161 | Background | Golish 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. |
| 14735066 | Background | Habermeyer 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. |
| 21051241 | Background | Hsu 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. |
| 20551285 | Background | Koh 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. |
| 19111216 | Background | Oh 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. |
| 26921128 | Background | Oh 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. |
| 28146397 | Background | Park 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. |
| 28899638 | Background | Pogorzelski 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. |
| 28194382 | Background | Ramos 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. |
| 21257843 | Background | Scheibel 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. |
| 15889020 | Background | Walch 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. |
| Background | Zehnder Sw, Kaar SG, Joy E. Transpectoral Biceps Sling Tenodesis: Surgical Technique. Tech Should Surg. 2011;12: 32-35. |
| FG001 | Suture Anchor Technique (SA) | 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. Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Suture Anchor Technique (SA) | 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. Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques |
| BG001 | Pectoralis Major Technique (PMT) | 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. Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| The American Shoulder and Elbow Surgeons Shoulder Score (ASES) | 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. | Median | Full Range | scores on a scale |
| ||||||||||||||
| The 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. | Median | Full Range | scores on a scale |
| ||||||||||||||
| Visual Analog 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 their pain level on the line between the two endpoints. "0" is no pain and "10" is pain as bad as it could be on the scale. The score on a scale represents the number, or score, that the patient selected to for their level of pain. | Median | Full Range | score on a scale |
| ||||||||||||||
| 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. | Median | Full Range | score on a scale |
| ||||||||||||||
| 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 outcome. | Baseline data was not collected on one subject for this measure and the patient was lost to follow up for subsequent scoring. | Median | Full Range | scores on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Sample size too small. Baseline data was collected on three of the four subjects and due to COVID-19 and the PI leaving research institution, additional long-term data not collected on remaining subjects. | Posted | Median | Full Range | units on a scale | This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported. |
|
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Sample size too small. Baseline data was collected on all four subjects, but due to COVID-19 and the PI leaving research institution, additional long-term data not collected on all subjects. One subject was lost to follow up for outcome measure time frames. | Posted | Median | Full Range | score on a scale | This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported. |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Sample size too small. Baseline data was collected on all four subjects, but due to COVID-19 and the PI leaving research institution, additional long-term data not collected on all subjects. One subject was lost to follow up for outcome measure time frames. | Posted | Median | Full Range | score on a scale | This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported. |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Sample size too small. Baseline data was collected on all four subjects, but due to COVID-19 and the PI leaving research institution, additional long-term data not collected on all subjects. One subject was lost to follow up for outcome measure time frames. | Posted | Median | Full Range | units on a scale | This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported. |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Sample size too small. Baseline data was collected on all four subjects, but due to COVID-19 and the PI leaving research institution, additional long-term data not collected on all subjects. One subject was lost to follow up for outcome measure time frames. | Posted | Median | Full Range | score on a scale | This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported. |
|
Adverse event data was reviewed at each study visit during course of study. Six months was the maximum that patients were followed.
No adverse events were reported in the four subjects.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Suture Anchor Technique (SA) | 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. Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | Pectoralis Major Technique (PMT) | 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. Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
Not provided
Early termination of study due to COVID-19 and later the departure of PI from institution.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Dawson, Research Nurse | Saint Louis University | 314-977-4106 | sarah.dawson@health.slu.edu |
| Mar 12, 2021 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 19, 2019 | Mar 12, 2021 | ICF_003.pdf |
Not provided
| ID | Term |
|---|---|
| D013717 | Tenosynovitis |
| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
|
|
|
|
|
|
|
| 6 Month Data |
|
|
|
|
|
|
|
|
| OG001 | Pectoralis Major Technique (PMT) | 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. Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques |
|
|