SLAP Repair vs. Biceps Tenodesis in Patients Under 30: A Randomized Clinical Trial

Study Overview
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Brief Summary
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One of the common complaints after SLAP repair is pain and stiffness. However, the more recently-described Biceps Tenodesis for SLAP tears improves upon this by addressing the long head of biceps which is thought to be the pain sources. However, only one small prior RCT has evaluated this, finding minimal difference. Both procedures are currently considered standard of care, and are decided upon based on patient and surgeon preference. This will be a single-center randomized controlled trial. The study is comparing SLAP repair and biceps tenodesis in patients under 30 undergoing surgery for SLAP tears. The purpose of the proposed study is to evaluate the effect of SLAP repair versus biceps tenodesis in the management of SLAP tears in patients under 30 years old.

Detailed Description
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Superior-labrum anterior to posterior (SLAP) tears were first described by Andrews et al. in 1985, and have been reported to be present in up to 26% of shoulder arthroscopies. While the exact cause of SLAP tears is unknown, they are often related to traumatic events and sports activity, particularly overhead sports such as baseball. Type II SLAP tears, which are characterized by superior labral fraying with a detached biceps anchor, are the most common subtype, based on the classification by Snyder et al. Treatment options include SLAP repair, biceps tenodesis, biceps tenotomy, and debridement. One of the common complaints after SLAP repair is pain and stiffness. However, the more recently-described Biceps Tenodesis for SLAP tears improves upon this by addressing the long head of biceps which is thought to be the pain sources. However, only one small prior RCT has evaluated this, finding minimal difference. Both procedures are currently considered standard of care, and are decided upon based on patient and surgeon preference. This will be a single-center randomized controlled trial. The study is comparing SLAP repair and biceps tenodesis in patients under 30 undergoing surgery for SLAP tears. The purpose of the proposed study is to evaluate the effect of SLAP repair versus biceps tenodesis in the management of SLAP tears in patients under 30 years old.

Official Title
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SLAP Repair vs. Biceps Tenodesis in Patients Under 30: A Randomized Clinical Trial

Conditions
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SLAP Tear

Intervention / Treatment
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* Procedure: Self-Locking Tenotomy
* Procedure: Biceps Tenodesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary indication is for SLAP tear Age 18-30 Willing and able to provide consent Exclusion Criteria: Associated rotator cuff tear requiring arthroscopic repair Pregnant patient Previous shoulder surgery Age > 30, or < 18

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biceps Tenodesis<br> | Procedure: Biceps Tenodesis<br>* Biceps tenodesis describes the surgical procedure that will be performed to treat SLAP tears.<br>|
| Active Comparator: SLAP Repair (Control)<br> | Procedure: Self-Locking Tenotomy<br>* Self-locking Tenotomy describes the surgical procedure that will be performed to treat SLAP tears.<br>* Other names: SLAP Repair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Score on Visual Analogue Scale (VAS) Scale | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain possible. The total score range is 0-10. The higher the score, the higher the pain level experienced. | 3 months post-op, 24 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale | The ASES scale consists of two subscales: pain (0-50 points) and function/disability (0-50 points), with a total score range of 0-100 points. The lower the score, the greater the pain and disability. | 3 months post-op, 24 months post-op | 
| Change in Score on Kerlan-Jobe Orthopaedic Clinical Shoulder & Elbow (KJOC) Questionnaire | The KJOC Score includes 10 questions with an 11-point Likert scale in the form of blocks to be ticked from 0 to 10. The total score is equal to the sum of the values of the 10 responses. The higher the score, the greater the shoulder function. | 3 months post-op, 24 months post-op | 
| Change in Score on Shoulder Instability-Return to Sport after Injury (SIRSI) Questionnaire | The SIRSI includes 12 questions with an 11-point Likert scale in the form of blocks to be ticked from 0 to 10. The total score is equal to the sum of the values of the 12 responses then determined in relation to 100 to obtain a percentage (0-100%). The higher the score (%), the more positive the psychological response. | 3 months post-op, 24 months post-op | 
| Average timing of return to work/sport |  | up to 24 months post-op | 
| Incidence of re-operations |  | up to 24 months post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLAP Repair, Biceps Tenodesis