Clinical Trials Directory

Trials / Completed

CompletedNCT04494932

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
NYU Langone Health · Academic / Other
Sex
All
Age
18 Years – 30 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDURESelf-Locking TenotomySelf-locking Tenotomy describes the surgical procedure that will be performed to treat SLAP tears.
PROCEDUREBiceps TenodesisBiceps tenodesis describes the surgical procedure that will be performed to treat SLAP tears.

Timeline

Start date
2020-09-01
Primary completion
2021-12-08
Completion
2021-12-08
First posted
2020-07-31
Last updated
2024-08-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04494932. Inclusion in this directory is not an endorsement.