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

NCT ID: NCT04494932

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-12-08

Brief Summary

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

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.

Conditions

SLAP Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biceps Tenodesis

Group Type: EXPERIMENTAL

Biceps Tenodesis

Intervention Type: PROCEDURE

Biceps tenodesis describes the surgical procedure that will be performed to treat SLAP tears.

SLAP Repair (Control)

Group Type: ACTIVE_COMPARATOR

Self-Locking Tenotomy

Intervention Type: PROCEDURE

Self-locking Tenotomy describes the surgical procedure that will be performed to treat SLAP tears.

Interventions

Self-Locking Tenotomy

Self-locking Tenotomy describes the surgical procedure that will be performed to treat SLAP tears.

Intervention Type: PROCEDURE

Biceps Tenodesis

Biceps tenodesis describes the surgical procedure that will be performed to treat SLAP tears.

Intervention Type: PROCEDURE

Other Intervention Names

SLAP Repair

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laith Jazrawi, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

20-01027

Identifier Type: -

Identifier Source: org_study_id