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Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation

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ClinicalTrials.gov Identifier: NCT03585491
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
McMaster University
University of Michigan
Information provided by (Responsible Party):
Moin Khan, McMaster University

Brief Summary:
The primary objective of the pilot study is to assess the feasibility of a definitive trial to determine the effect of arthroscopic capsuloligamentous repair vs. coracoid transfer (Latarjet procedure) on recurrent dislocation rates and functional outcomes over a 24-month period.

Condition or disease Intervention/treatment Phase
Shoulder Dislocation Sport Injuries Shoulder Anterior Dislocation Procedure: Latarjet Procedure Procedure: Bankart Procedure Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : January 1, 2022

Arm Intervention/treatment
Experimental: Bankart Procedure
Bankart Procedure: the participant will be placed in the lateral decubitus or beach chair position. Standard diagnostic arthroscopy will be performed. The anterior capsulolabral complex will be freed from the anterior aspect of the scapular neck. The anterior aspect of the scapular neck will be decorticated using a motorized burr. A capsuloligamentous repair will be performed with the capsule shifted from inferior to superior and repaired on the glenoid face. The number of anchors used for the repair will be left to the discretion of the surgeon. Patients will be given a sling for 4 weeks, and participation in sports will not be allowed for 6 months.
Procedure: Bankart Procedure
Participants will undergo arthroscopic stabilization.

Experimental: Latarjet Procedure
Open or Arthroscopic coracoid transfer (Latarjet Procedure): This procedure may be performed through small incisions (minimally invasive) but may require a larger incision in some cases. It involves the transfer of a nearby bony structure (the coracoid process) to the front of the shoulder joint (glenoid). This bone will then provide support to prevent the shoulder joint from dislocating.
Procedure: Latarjet Procedure
Participants will undergo open or arthroscopic Latarjet procedure.




Primary Outcome Measures :
  1. Recruitment Feasibility [ Time Frame: 10 months ]
    Number of patients recruited

  2. Protocol Adherence [ Time Frame: 2 years ]
    Number of errors in randomization

  3. Follow-up [ Time Frame: 2 years ]
    Proportion of participants followed at two years


Secondary Outcome Measures :
  1. Rate of Recurrence [ Time Frame: 2 years ]
    Rate of recurrent dislocation and symptomatic instability between patients randomized to (capsuloligamentous repair +/- remplissage) and those receiving open Latarjet procedure.

  2. Clinical Outcome [ Time Frame: 2 years ]
    Measured by Western Ontario Shoulder Instability (WOSI) Index

  3. Clinical Outcome [ Time Frame: 2 years ]
    Measured by American Shoulder and Elbow Society (ASES) score



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ages 18-50 years;
  • Diagnosis of post-traumatic recurrent anterior dislocation. This will require a minimum of 2 episodes of documented dislocations either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms;
  • Mild glenoid bone loss as defined on CT by standardized and reproducible best-fit circle technique (>10% but <20%);
  • Provision of informed consent.

Exclusion Criteria:

  • Patients with concomitant injuries (cuff tear);
  • Previous shoulder surgery;
  • Patients that will likely have problems, in the judgment of the investigators, with maintaining follow-up;
  • Epilepsy;
  • Patients who are or at risk of being incarcerated;
  • Diagnosis of multidirectional instability;
  • Cases involving litigation or workplace insurance claims (e.g. WSIB);
  • Confirmed connective tissue disorder (Ehlers-Danlos, Marfans) or Beighton hypermobility score > 6.

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): NCT03585491


Contacts
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Contact: Nazanin Barkhordari 416-627-9367 barkhorn@mcmaster.ca
Contact: Moin Khan, MD 905-522-1155 ext 32953 moinkhanmd@gmail.com

Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Nazanin Barkhordari    4166279367    barkhorn@mcmaster.ca   
Principal Investigator: Moin Khan, MD, MSc,FRCSC         
Sponsors and Collaborators
Moin Khan
McMaster University
University of Michigan
Investigators
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Principal Investigator: Moin Khan, MD McMaster University

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Responsible Party: Moin Khan, MD, MSc, FRCSC, McMaster University
ClinicalTrials.gov Identifier: NCT03585491     History of Changes
Other Study ID Numbers: STABLE
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Joint Dislocations
Shoulder Dislocation
Athletic Injuries
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries