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

October 28, 2019 updated by: HealthPartners Institute

SLAP Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder: A Randomized Outcomes Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • TRIA Orthopaedic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SLAP Repair
Patient will receive SLAP repair for their SLAP tear.
Procedure: SLAP Repair
SLAP repair for SLAP tear
Experimental: Biceps Tenodesis Repair
Patient will receive biceps tenodesis repair for their SLAP tear.
Procedure: Biceps Tenodesis
Biceps tenodesis for SLAP tear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported function and pain
Time Frame: Baseline
American Shoulder and Elbow Surgeons (ASES)
Baseline
Patient reported function and pain
Time Frame: 6 months
ASES
6 months
Patient reported function and pain
Time Frame: 1 year
ASES
1 year
Patient reported function and pain
Time Frame: 2 years
ASES
2 years
Patient reported function and pain
Time Frame: 5 years
ASES
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion & Strength
Time Frame: Baseline
Shoulder/elbow range of motion and strength measurements
Baseline
Range of Motion
Time Frame: 3 months
Shoulder/elbow range of motion
3 months
Range of Motion & Strength
Time Frame: 6 months
Shoulder/elbow range of motion and strength measurements
6 months
Range of Motion & Strength
Time Frame: 1 year
Shoulder/elbow range of motion and strength measurements
1 year
Range of Motion & Strength
Time Frame: 2 years
Shoulder/elbow range of motion and strength measurements
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1401M47421

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on SLAP Tear

Clinical Trials on SLAP Repair

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe