Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability

• ClinicalTrials.gov Identifier: NCT03453710
• Recruitment Status: Recruiting
• First Posted: March 5, 2018
• Last Update Posted: November 1, 2021
• Sponsor: Western University, Canada
• Collaborator: Panam Clinic
• Information provided by (Responsible Party): Western University, Canada

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.

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 Design

• 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
• Actual Study Start Date: October 1, 2018
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

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.

Outcome Measures

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.

   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

Eligibility Criteria

• 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,
• psychiatric illness that precludes informed consent,
• unwilling to be followed for 2 years

Contacts and Locations

Contacts

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

Locations

Canada, Manitoba

Pan Am Clinic; 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; 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

More Information

• Responsible Party: Western University, Canada
• ClinicalTrials.gov Identifier: NCT03453710
• Other Study ID Numbers: 111328
• First Posted: March 5, 2018
• Last Update Posted: November 1, 2021
• Last Verified: October 2021

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

Additional relevant MeSH terms:

Shoulder Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries