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

SLAP Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04494932
• Other study ID #: 20-01027
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Injuries
• SLAP Tear

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Average timing of return to work/sport		up to 24 months post-op
Secondary	Incidence of re-operations		up to 24 months post-op