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

NCT ID: NCT02296554

Last Updated: 2019-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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SLAP Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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SLAP Repair

Patient will receive SLAP repair for their SLAP tear.

Group Type EXPERIMENTAL

SLAP Repair

Intervention Type PROCEDURE

SLAP repair for SLAP tear

Biceps Tenodesis Repair

Patient will receive biceps tenodesis repair for their SLAP tear.

Group Type EXPERIMENTAL

Biceps Tenodesis

Intervention Type PROCEDURE

Biceps tenodesis for SLAP tear

Interventions

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SLAP Repair

SLAP repair for SLAP tear

Intervention Type PROCEDURE

Biceps Tenodesis

Biceps tenodesis for SLAP tear

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TRIA Orthopaedic Center

Bloomington, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1401M47421

Identifier Type: -

Identifier Source: org_study_id

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