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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03453710
Recruitment Status : Not yet recruiting
First Posted : March 5, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Panam Clinic
Information provided by (Responsible Party):
Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Shoulder Dislocation Procedure: Bankart Repair plus Remplissage Procedure: Latarjet coracoid transfer Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized controlled trial
Masking: Single (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.
Primary Purpose: Treatment
Official Title: Arthroscopic Bankart Repair and Remplissage Versus Latarjet Coracoid Transfer for Recurrent Anterior Glenohumeral Instability With Subcritical Bone Loss - A Randomized Controlled Trial
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Active Comparator: Bankart Repair and Remplissage
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.
Procedure: Bankart Repair plus Remplissage

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.


Active Comparator: Latarjet Coracoid Transfer
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
Procedure: Latarjet coracoid transfer
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 Measures :
  1. Western Ontario Shoulder Instability (WOSI) Score [ Time Frame: 24 months ]

    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.

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    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 :
  1. Pain numeric rating scale (NRS) [ Time Frame: 24 months ]
    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

  2. Simple Shoulder Test (SST) [ Time Frame: 24 months ]
    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

  3. American Shoulder and Elbow Society (ASES) assessment [ Time Frame: 24 months ]
    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

  4. Range of motion [ Time Frame: 24 months ]
    Range of motion will be evaluated using a goniometer to calculate: forward flexion, abduction, external rotation and internal rotation

  5. Post-operative complications [ Time Frame: 24 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,
  • Wallet Sequin Retro Womens Wallet Purse Wallet Handbag Coin Ladies Noopvan Small Black Clutch 2018 Clearance psychiatric illness that precludes informed consent,
  • unwilling to be followed for 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453710


Contacts
Contact: Stacey Wanlin 519-661-3111 ext 82705 swanlin@uwo.ca

Locations
Canada, Manitoba
Pan Am Clinic Not yet recruiting
Winnipeg, Manitoba, Canada, R3M 3E4
Contact: Peter MacDonald, MD    (204) 925-1550    pmacdonald@panamclinic.com   
Principal Investigator: Peter MacDonald, MD         
Canada, Ontario
Fowler Kennedy Sport Medicine Clinic Not yet recruiting
London, Ontario, Canada, N6A 3K7
Contact: Ryan M Degen, MD    519-661-2171    ryan.degen@lhsc.on.ca   
Contact: Stacey Wanlin       swanlin@uwo.ca   
Principal Investigator: Ryan M Degen, MD         
Principal Investigator: Robert Litchfield, MD         
Sponsors and Collaborators
Western University, Canada
Panam Clinic

Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT03453710     History of Changes
Other Study ID Numbers: 111328
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: Clearance 2018 Black Sequin Noopvan Clutch Small Wallet Wallet Coin Womens Retro Handbag Wallet Purse Ladies January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Western University, Canada:
Bankart Repair
Remplissage
Latarjet coracoid transfer
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Additional relevant MeSH terms:
Shoulder Dislocation
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries

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