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Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability

Primary Purpose

Shoulder Dislocation

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bankart Repair plus Remplissage
Latarjet coracoid transfer
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation focused on measuring Bankart Repair, Remplissage, Latarjet coracoid transfer

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pan Am ClinicRecruiting
  • Fowler Kennedy Sport Medicine ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bankart Repair and Remplissage

Latarjet Coracoid Transfer

Arm Description

Patients randomized to the all-arthroscopic group (Bankart repair and remplissage) will undergo a standard arthroscopic anterior labral repair with a minimum of 3 suture anchors, followed by remplissage with 1 or 2 anchors, at the discretion of the treating surgeon.

Patients randomized to the open Latarjet coracoid transfer will undergo a Latarjet coracoid transfer through a deltopectoral approach and horizontal split in the subscapularis at the superior 2/3, inferior 1/3 junction. The coracoid process will be oriented in the conventional manner, with the inferior surface against the glenoid vault, secured with two cannulated screws

Outcomes

Primary Outcome Measures

Western Ontario Shoulder Instability (WOSI) Score
Western Ontario Shoulder Instability (WOSI) questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems. Difference between study arm outcomes will be assessed using pre-op and post-op WOSI score as a covariate. This questionnaire has 21 questions, each scored on a scale from 0 to 100, with 0 being the best score (no limitations related to the shoulder) and 100 representing the worst score. Overall, the questionnaire is scored as a percentage of the maximum score of 2100 points. There are subscale components reporting on: physical symptoms (questions 1 through 10; maximum score of 1000); sports/recreation/work (questions 11 through 14; maximum score 400); lifestyle (questions 15 through 18; maximum score 400); and emotion (questions 19-21; maximum score 300). Subscale scores are added to determine the total score out of a possible 2100 points, with 2100, or 100%, representing the worst possible score.

Secondary Outcome Measures

Pain numeric rating scale (NRS)
This tool is designed to evaluate pain. The Scale is from 0-100 to determine shoulder pain pre and post-operatively; 0=extreme pain, 100=no pain
Simple Shoulder Test (SST)
Simple Shoulder Test (SST) is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. The answers to these questions provides a standardized way of recording the function of a shoulder before and after treatment. Differences between study arm outcomes will be assessed using pre-op SST scores as a covariate
American Shoulder and Elbow Society (ASES) assessment
The ASES assessment (patient report section) is a region-specific questionnaire designed for self-assessment of aspects of pain and function. Difference between study arm outcomes will be assessed using pre-op ASES score as a covariate
Range of motion
Range of motion will be evaluated using a goniometer to calculate: forward flexion, abduction, external rotation and internal rotation
Post-operative complications
Post-surgical complications will be collected including: neurologic injury (neuropraxia); superficial wound infection; deep surgical site infection; coracoid non-union or malunion; posterior shoulder pain; stiffness; recurrent instability

Full Information

First Posted
February 27, 2018
Last Updated
April 25, 2023
Sponsor
Western University, Canada
Collaborators
Panam Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03453710
Brief Title
Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability
Official Title
Arthroscopic Bankart Repair and Remplissage Versus Latarjet Coracoid Transfer for Recurrent Anterior Glenohumeral Instability With Subcritical Bone Loss - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada
Collaborators
Panam Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation
Keywords
Bankart Repair, Remplissage, Latarjet coracoid transfer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Patients will be evaluated by a blinded study nurse, unaware of treatment allocation, for administration of baseline questionnaires, as well as subsequent post-operative questionnaires.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bankart Repair and Remplissage
Arm Type
Active Comparator
Arm Description
Patients randomized to the all-arthroscopic group (Bankart repair and remplissage) will undergo a standard arthroscopic anterior labral repair with a minimum of 3 suture anchors, followed by remplissage with 1 or 2 anchors, at the discretion of the treating surgeon.
Arm Title
Latarjet Coracoid Transfer
Arm Type
Active Comparator
Arm Description
Patients randomized to the open Latarjet coracoid transfer will undergo a Latarjet coracoid transfer through a deltopectoral approach and horizontal split in the subscapularis at the superior 2/3, inferior 1/3 junction. The coracoid process will be oriented in the conventional manner, with the inferior surface against the glenoid vault, secured with two cannulated screws
Intervention Type
Procedure
Intervention Name(s)
Bankart Repair plus Remplissage
Intervention Description
Arthroscopic Bankart repair with a minimum of 3 anchors 1 or 2 anchor Remplissage subsequently performed with percutaneous anchor insertion in the base of the Hill-Sachs defect, and sutures passed in a horizontal mattress configuration 1 cm apart, tied in the subacromial space.
Intervention Type
Procedure
Intervention Name(s)
Latarjet coracoid transfer
Intervention Description
Coracoid transfer performed via deltopectoral approach with horizontal subscapularis split. Graft placed in the conventional orientation, secured with 2 screws, ensuring the graft is not lateral to the glenoid rim.
Primary Outcome Measure Information:
Title
Western Ontario Shoulder Instability (WOSI) Score
Description
Western Ontario Shoulder Instability (WOSI) questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems. Difference between study arm outcomes will be assessed using pre-op and post-op WOSI score as a covariate. This questionnaire has 21 questions, each scored on a scale from 0 to 100, with 0 being the best score (no limitations related to the shoulder) and 100 representing the worst score. Overall, the questionnaire is scored as a percentage of the maximum score of 2100 points. There are subscale components reporting on: physical symptoms (questions 1 through 10; maximum score of 1000); sports/recreation/work (questions 11 through 14; maximum score 400); lifestyle (questions 15 through 18; maximum score 400); and emotion (questions 19-21; maximum score 300). Subscale scores are added to determine the total score out of a possible 2100 points, with 2100, or 100%, representing the worst possible score.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Pain numeric rating scale (NRS)
Description
This tool is designed to evaluate pain. The Scale is from 0-100 to determine shoulder pain pre and post-operatively; 0=extreme pain, 100=no pain
Time Frame
24 months
Title
Simple Shoulder Test (SST)
Description
Simple Shoulder Test (SST) is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. The answers to these questions provides a standardized way of recording the function of a shoulder before and after treatment. Differences between study arm outcomes will be assessed using pre-op SST scores as a covariate
Time Frame
24 months
Title
American Shoulder and Elbow Society (ASES) assessment
Description
The ASES assessment (patient report section) is a region-specific questionnaire designed for self-assessment of aspects of pain and function. Difference between study arm outcomes will be assessed using pre-op ASES score as a covariate
Time Frame
24 months
Title
Range of motion
Description
Range of motion will be evaluated using a goniometer to calculate: forward flexion, abduction, external rotation and internal rotation
Time Frame
24 months
Title
Post-operative complications
Description
Post-surgical complications will be collected including: neurologic injury (neuropraxia); superficial wound infection; deep surgical site infection; coracoid non-union or malunion; posterior shoulder pain; stiffness; recurrent instability
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey Wanlin
Phone
519-661-3111
Ext
82705
Email
swanlin@uwo.ca
Facility Information:
Facility Name
Pan Am Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter MacDonald, MD
Phone
(204) 925-1550
Email
pmacdonald@panamclinic.com
First Name & Middle Initial & Last Name & Degree
Peter MacDonald, MD
Facility Name
Fowler Kennedy Sport Medicine Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan M Degen, MD
Phone
519-661-2171
Email
ryan.degen@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Stacey Wanlin
Email
swanlin@uwo.ca
First Name & Middle Initial & Last Name & Degree
Ryan M Degen, MD
First Name & Middle Initial & Last Name & Degree
Robert Litchfield, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability

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