SLAP Repair vs. Biceps Tenodesis in Patients Under 30: A Randomized Clinical Trial
Primary Purpose
SLAP Tear
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Locking Tenotomy
Biceps Tenodesis
Sponsored by
About this trial
This is an interventional treatment trial for SLAP Tear focused on measuring SLAP Repair, Biceps Tenodesis
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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biceps Tenodesis
SLAP Repair (Control)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Average timing of return to work/sport
Incidence of re-operations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04494932
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SLAP Tear
Keywords
SLAP Repair, Biceps Tenodesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biceps Tenodesis
Arm Type
Experimental
Arm Title
SLAP Repair (Control)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Self-Locking Tenotomy
Other Intervention Name(s)
SLAP Repair
Intervention Description
Self-locking Tenotomy describes the surgical procedure that will be performed to treat SLAP tears.
Intervention Type
Procedure
Intervention Name(s)
Biceps Tenodesis
Intervention Description
Biceps tenodesis describes the surgical procedure that will be performed to treat SLAP tears.
Primary Outcome Measure Information:
Title
Change in Score on Visual Analogue Scale (VAS) Scale
Description
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.
Time Frame
3 months post-op, 24 months post-op
Secondary Outcome Measure Information:
Title
Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale
Description
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.
Time Frame
3 months post-op, 24 months post-op
Title
Change in Score on Kerlan-Jobe Orthopaedic Clinical Shoulder & Elbow (KJOC) Questionnaire
Description
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.
Time Frame
3 months post-op, 24 months post-op
Title
Change in Score on Shoulder Instability-Return to Sport after Injury (SIRSI) Questionnaire
Description
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.
Time Frame
3 months post-op, 24 months post-op
Title
Average timing of return to work/sport
Time Frame
up to 24 months post-op
Title
Incidence of re-operations
Time Frame
up to 24 months post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laith Jazrawi, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
SLAP Repair vs. Biceps Tenodesis in Patients Under 30: A Randomized Clinical Trial
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