Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability

  • STATUS
    Recruiting
  • days left to enroll
    29
  • participants needed
    30
  • sponsor
    Western University, Canada
Updated on 14 June 2022

Summary

This is a pilot study designed as a prospective, randomized controlled trial comparing arthroscopic Bankart repair and Remplissage with an open Latarjet coracoid transfer for the treatment of recurrent anterior glenohumeral instability with subcritical bone loss.

Description

Presently, consensus guidelines for the surgical management of anterior glenohumeral instability are lacking. While there has been continual evolution in available arthroscopic instrumentation, this has not translated to improvements in patient outcomes. Isolated arthroscopic bankart repair is often associated with unacceptably high rates of failure, with a recent systematic review identifying continued recurrence rates of 14.2%. Improved recognition of bone defects and identification of critical defect sizes that contribute to recurrent instability and failed stabilization have lead to improvements in treatment algorithms. It has been widely accepted that glenoid defects exceeding 20% of anteroposterior (AP) width and humeral head defects exceeding 30% of the humeral head width contribute to recurrent instability. For defects of this magnitude, isolated arthroscopic Bankart repair is insufficient in restoring joint stability, and more extensive procedures are required. This can include adding a remplissage to the arthroscopic Bankart repair or open allograft reconstruction for humeral defects; or Latarjet coracoid transfer for glenoid defects.

However, often patients present with combined 'bipolar' bone loss, where individual defects are subcritical in size. There is increasing recognition that the presence of this combined bone loss may lead to increased rates of failure with an isolated arthroscopic bankart repair. Currently, accepted treatment options for bipolar bone loss include a combined arthroscopic Bankart repair and remplissage, or a Latarjet coracoid transfer. While there is supportive biomechanical data for each procedure, and limited case series in the literature, there remains a paucity of high-quality evidence to guide treatment for this complex clinical scenario. Consequently, we aim to perform a pilot study designed as a prospective, randomized controlled trial comparing arthroscopic Bankart repair and Remplissage with an open Latarjet coracoid transfer.

Details
Condition Shoulder Dislocation
Treatment Bankart Repair plus Remplissage, Latarjet coracoid transfer
Clinical Study IdentifierNCT03453710
SponsorWestern University, Canada
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

anterior shoulder instability (>1 dislocation)
age >14 years
evidence of a Hill-Sachs defect on MRI or CT
< 20% anteroposterior glenoid bone loss

Exclusion Criteria

>20% anteroposterior glenoid bone loss
significant shoulder comorbidities (i.e., osteoarthritis, previous surgery other than previous instability), active joint or systemic infection, significant muscle paralysis, rotator cuff or Charcot's arthropathy
significant medical comorbidity that may alter effectiveness of surgical intervention
major medical illness
unable to speak French or English
psychiatric illness that precludes informed consent
unwilling to be followed for 2 years
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note