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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2022

Detailed Description

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.

Interventions

  • Procedure: Self-Locking Tenotomy
    • Self-locking Tenotomy describes the surgical procedure that will be performed to treat SLAP tears.
  • Procedure: Biceps Tenodesis
    • Biceps tenodesis describes the surgical procedure that will be performed to treat SLAP tears.

Arms, Groups and Cohorts

  • Experimental: Biceps Tenodesis
  • Active Comparator: SLAP Repair (Control)

Clinical Trial Outcome Measures

Primary Measures

  • Change in Score on Visual Analogue Scale (VAS) Scale
    • Time Frame: 3 months post-op, 24 months post-op
    • 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.

Secondary Measures

  • Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale
    • Time Frame: 3 months post-op, 24 months post-op
    • 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.
  • Change in Score on Kerlan-Jobe Orthopaedic Clinical Shoulder & Elbow (KJOC) Questionnaire
    • Time Frame: 3 months post-op, 24 months post-op
    • 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.
  • Change in Score on Shoulder Instability-Return to Sport after Injury (SIRSI) Questionnaire
    • Time Frame: 3 months post-op, 24 months post-op
    • 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.
  • Average timing of return to work/sport
    • Time Frame: up to 24 months post-op
  • Incidence of re-operations
    • Time Frame: up to 24 months post-op

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NYU Langone Health
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Laith Jazrawi, MD, Principal Investigator, NYU Langone Health
  • Overall Contact(s)
    • Laith Jazrawi, MD, 6465017223, laith.jazrawi@nyulangone.org

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