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

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 Overview

• Status: Completed
• Conditions: SLAP Tear
• Intervention / Treatment: Procedure: Biceps Tenodesis; Procedure: Self-Locking Tenotomy

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
Average timing of return to work/sport		up to 24 months post-op
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
Incidence of re-operations		up to 24 months post-op

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Laith Jazrawi, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): December 8, 2021
• Study Completion (Actual): December 8, 2021

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: SLAP Repair; Biceps Tenodesis
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries
• Other Study ID Numbers: 20-01027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to use the data upon reasonable request. Requests should be directed to laith.jazrawi@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No