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Superior Labral Tear From Anterior to Posterior (SLAP) Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder (SLAP)

Primary Purpose

SLAP Tear

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SLAP Repair
Biceps Tenodesis
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SLAP Tear focused on measuring SLAP Repair, Biceps Tenodesis

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Primary isolated SLAP tear, confirmed on MRI

Exclusion Criteria:

  • Concomitant procedure needed such as a labral repair, rotator cuff repair or distal clavicle excision.
  • Revision Surgery
  • Previous shoulder surgery
  • Major medical illness
  • Inability to speak or read English

Sites / Locations

  • TRIA Orthopaedic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SLAP Repair

Biceps Tenodesis Repair

Arm Description

Patient will receive SLAP repair for their SLAP tear.

Patient will receive biceps tenodesis repair for their SLAP tear.

Outcomes

Primary Outcome Measures

Patient reported function and pain
American Shoulder and Elbow Surgeons (ASES)
Patient reported function and pain
ASES
Patient reported function and pain
ASES
Patient reported function and pain
ASES
Patient reported function and pain
ASES

Secondary Outcome Measures

Range of Motion & Strength
Shoulder/elbow range of motion and strength measurements
Range of Motion
Shoulder/elbow range of motion
Range of Motion & Strength
Shoulder/elbow range of motion and strength measurements
Range of Motion & Strength
Shoulder/elbow range of motion and strength measurements
Range of Motion & Strength
Shoulder/elbow range of motion and strength measurements

Full Information

First Posted
November 10, 2014
Last Updated
October 28, 2019
Sponsor
HealthPartners Institute
Collaborators
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02296554
Brief Title
Superior Labral Tear From Anterior to Posterior (SLAP) Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder
Acronym
SLAP
Official Title
SLAP Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder: A Randomized Outcomes Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Biceps Tenodesis is currently advocated for older, less active patients, but to date is not often advocated for Superior Labral Tear from Anterior to Posterior (SLAP) tears in young, active patients. The ideal surgical management for this pathology is not clearly known. More surgeons are using biceps tenodesis as a treatment for SLAP tears, including in the young, active population. If this study were to demonstrate that biceps tenodesis is similar to or better than SLAP repair, this would fundamentally change the treatment of SLAP tears. Perhaps more importantly, it would likely mean a less involved rehabilitation and earlier return to activities for patients with this pathology.

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
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SLAP Repair
Arm Type
Experimental
Arm Description
Patient will receive SLAP repair for their SLAP tear.
Arm Title
Biceps Tenodesis Repair
Arm Type
Experimental
Arm Description
Patient will receive biceps tenodesis repair for their SLAP tear.
Intervention Type
Procedure
Intervention Name(s)
SLAP Repair
Intervention Description
SLAP repair for SLAP tear
Intervention Type
Procedure
Intervention Name(s)
Biceps Tenodesis
Intervention Description
Biceps tenodesis for SLAP tear
Primary Outcome Measure Information:
Title
Patient reported function and pain
Description
American Shoulder and Elbow Surgeons (ASES)
Time Frame
Baseline
Title
Patient reported function and pain
Description
ASES
Time Frame
6 months
Title
Patient reported function and pain
Description
ASES
Time Frame
1 year
Title
Patient reported function and pain
Description
ASES
Time Frame
2 years
Title
Patient reported function and pain
Description
ASES
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Range of Motion & Strength
Description
Shoulder/elbow range of motion and strength measurements
Time Frame
Baseline
Title
Range of Motion
Description
Shoulder/elbow range of motion
Time Frame
3 months
Title
Range of Motion & Strength
Description
Shoulder/elbow range of motion and strength measurements
Time Frame
6 months
Title
Range of Motion & Strength
Description
Shoulder/elbow range of motion and strength measurements
Time Frame
1 year
Title
Range of Motion & Strength
Description
Shoulder/elbow range of motion and strength measurements
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Primary isolated SLAP tear, confirmed on MRI Exclusion Criteria: Concomitant procedure needed such as a labral repair, rotator cuff repair or distal clavicle excision. Revision Surgery Previous shoulder surgery Major medical illness Inability to speak or read English
Facility Information:
Facility Name
TRIA Orthopaedic Center
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Superior Labral Tear From Anterior to Posterior (SLAP) Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder

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