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

NCT04494932 | Completed

• 1 other identifier: 20-01027
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

SLAP Tear

Keywords

SLAP Repair; Biceps Tenodesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale

  3 months post-op, 24 months post-op

• Change in Score on Kerlan-Jobe Orthopaedic Clinical Shoulder & Elbow (KJOC) Questionnaire

  3 months post-op, 24 months post-op

• Change in Score on Shoulder Instability-Return to Sport after Injury (SIRSI) Questionnaire

  3 months post-op, 24 months post-op

• Average timing of return to work/sport

  up to 24 months post-op

• Incidence of re-operations

  up to 24 months post-op

Study Arms (2)

Biceps Tenodesis

EXPERIMENTAL

Procedure: Biceps Tenodesis

SLAP Repair (Control)

ACTIVE COMPARATOR

Procedure: Self-Locking Tenotomy

Interventions

Self-Locking Tenotomy PROCEDURE

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

Also known as: SLAP Repair

SLAP Repair (Control)

Biceps Tenodesis PROCEDURE

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

Biceps Tenodesis

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary indication is for SLAP tear
• Age 18-30
• Willing and able to provide consent

You may not qualify if:

• Associated rotator cuff tear requiring arthroscopic repair
• Pregnant patient
• Previous shoulder surgery
• Age \> 30, or \< 18

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Shoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Laith Jazrawi, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: September 1, 2020
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)