Clinical trial NCT04494932: SLAP Repair vs. Biceps Tenodesis in Patients Under 30: A Randomized Clinical Trial
Official title: SLAP Repair vs. Biceps Tenodesis in Patients Under 30: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SLAP Tear
Keywords: SLAP Repair
Biceps Tenodesis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Score on Visual Analogue Scale (VAS) Scale
timeFrame: 3 months post-op, 24 months post-op
Secondary outcomes:
measure: Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale
timeFrame: 3 months post-op, 24 months post-op
measure: Change in Score on Kerlan-Jobe Orthopaedic Clinical Shoulder & Elbow (KJOC) Questionnaire
timeFrame: 3 months post-op, 24 months post-op
measure: Change in Score on Shoulder Instability-Return to Sport after Injury (SIRSI) Questionnaire
timeFrame: 3 months post-op, 24 months post-op
measure: Average timing of return to work/sport
timeFrame: up to 24 months post-op
measure: Incidence of re-operations
timeFrame: up to 24 months post-op
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Laith Jazrawi, MD
role: PRINCIPAL_INVESTIGATOR
References: