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Which shoulder surgery is best? major trial aims to settle the debate

NCT ID NCT04809064

Disease control Sponsor: University of Pittsburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares three common surgeries for people with shoulder instability and moderate bone loss (10-20%). The goal is to see which procedure leads to better function, faster return to work or sports, and fewer repeat dislocations. The trial will follow 450 military and civilian participants for up to two years after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Shoulder stabilization surgery (arthroscopic Bankart repair with remplissage, open Bankart, or Latarjet)
What this could lead to
If successful, this trial could identify which surgical technique works best for shoulder instability with moderate bone loss, helping patients return to activity faster and with fewer repeat dislocations.
What could go wrong
This is a large trial but still observational in nature. Results may not apply to all patients, and individual outcomes depend on many factors like rehabilitation and injury severity.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Male and female military personnel and civilians between the ages of 17 and 50 with a traumatic anterior shoulder dislocation with associated 10-20% glenoid bone loss, having undergone either an 1) arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, 2) open Bankart, or a 3) Latarjet, and plans to return to physically demanding work or sports.

Ages

17 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Civilians and military personnel ages 17 to 50 * Traumatic anterior shoulder dislocation * Associated subcritical bone loss between 10-20% less the glenoid width quantified by standard of care CT scan, MRI, or 3D-MRI scan * Had shoulder instability surgery using either 1) arthroscopic Bankart repair with remplissage of Hill-Sachs lesion; 2) open Bankart; or 3) Latarjet Exclusion Criteria: * Chronic, non-traumatic multi-directional instability based on clinical exam * Concurrent shoulder injury in the involved shoulder (e.g., rotator cuff tears, motor nerve pathologies, osteoarthritis of a Samilson-Prieto grade \>2) * Have a history of shoulder surgery in the involved shoulder (prior instability surgery that included any of the following and the planned procedure would be a repeat of the index procedure: 1) arthroscopic Bankart repair with a remplissage of Hill-Sachs lesion, 2) open Bankart, or 3) Latarjet \[previous isolated arthroscopic Bankart repair only would not be an exclusion criterion\], rotator cuff repair, intra-articular soft tissue surgery); rotator cuff repair, intra-articular soft tissue surgery) * Prior rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery * Humeral sided bone lesions (Hill-Sachs lesion) that is sufficiently large enough to render the lesion "off-track" even after a bony augmentation procedure would be performed * Neuromuscular, neurological and other movement control pathologies including seizures * Vascular injury associated with the shoulder trauma that compromise adequate/normal healing or interferes with usual course of care * Traumatic brain injury or any condition that would preclude the ability to comply with post-operative guidelines * Cartilage lesion finding in the involved shoulder that would interfere with usual course of care * Known pregnancy at time of imagining and/or surgery based upon standard of care testing procedures * Any issue with the contralateral shoulder that would preclude participation in research procedures * Any condition in the opinion of the investigator/clinician that would preclude or limit full participation in study activities * Absence of a fixed address or no means of contact * Known inability to be available at all follow-up time points * Does not plan to return to pre-injury levels of work, sports or military duty

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Conditions

The condition(s) this trial relates to.

Shoulder Dislocation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anterior shoulder dislocation Glenohumeral dislocation Shoulder dislocation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Mayo Clinic

    RECRUITING

    Tempe, Arizona, 85288, United States

  • Naval Medical Center

    ACTIVE_NOT_RECRUITING

    San Diego, California, 92134, United States

  • Naval Medical Center Camp Lejeune

    ACTIVE_NOT_RECRUITING

    Marine Corps Base Camp Lejeune, North Carolina, 28547, United States

  • Ohio State University, Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43202, United States

  • Rhode Island Hospital - Brown University Health

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • San Antonio Military Medical Center

    RECRUITING

    Fort Sam Houston, Texas, 78234, United States

  • Steadman Clinic

    ACTIVE_NOT_RECRUITING

    Vail, Colorado, 81657, United States

  • US Naval Health Clinic (Academy)

    RECRUITING

    Annapolis, Maryland, 21402, United States

  • University of Connecticut Health Center

    ACTIVE_NOT_RECRUITING

    Farmington, Connecticut, 06030, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27517, United States

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15203, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Wake Forest University

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Walter Reed National Military Medical Center

    ACTIVE_NOT_RECRUITING

    Bethesda, Maryland, 20089, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.