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

• ClinicalTrials.gov Identifier: NCT03585491
• Recruitment Status: Recruiting
• First Posted: July 13, 2018
• Last Update Posted: March 8, 2021
• Sponsor: Moin Khan
• Collaborators: St. Joseph's Healthcare Hamilton; University of Michigan; University of Western Ontario, Canada; The Ottawa Hospital; Pan Am Clinic; University of Colorado, Denver; Queen's University; Sunnybrook Health Sciences Centre; Boston University; Hospital Vall d'Hebron; Campus Bio-Medico University; OLVG; Deventer Ziekenhuis; Banff Sport Medicine Foundation; McMaster University; Brantford General Hospital; London Health Sciences Centre; Parc de Salut Mar; Hospital Universitari de Bellvitge; Hospital Universitario La Paz; Hospital de Terrassa; Hospital Dr Sotero del Rio
• Information provided by (Responsible Party): Moin Khan, McMaster University

Study Description

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 (Bankart + Remplissage) 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 + Remplissage Procedure	Not Applicable

Detailed Description:

Background:

Shoulder is a highly mobile joint with the most directional range of movement compared to other joints in the body. Thus, the surrounding supporting structures of the shoulder joint compromise on the stability of the joint, in order to accomplish this wide range of motion.

Anterior dislocations, the most common type of shoulder dislocation, are often complicated by instability, and repeated dislocations. Shoulder instability results in pain and negatively impacts quality of life. Several long-term studies have demonstrated a relationship between the repeated dislocations and the risk of arthritis.

Surgical stabilization of the shoulder improves function and may reduce the risk of developing degenerative arthritis. Two procedures are commonly performed in patients with repeated dislocations: a bony transfer procedure (Latarjet) or a soft tissue procedure (Bankart + Remplissage). The Latarjet procedure involves transferring bone to the front of the shoulder. The Bankart + Remplissage procedure involves tightening the soft tissues at the front of the shoulder joint.

Although retrospective clinical studies have suggested a reduced recurrence rate with the Latarjet procedure, there is a higher reported complication rate and potential morbidity associated with the open procedure. Several case series from high-volume surgeons in Europe have suggested the Latarjet repair to be an acceptable and potentially favorable surgical approach for all cases of recurrent anterior shoulder dislocation, even in the primary setting and in the absence of significant glenoid cup bone loss. Retrospective analysis of soft tissue repair in comparison to open coracoid (Latarjet) procedure found at 10-year follow up, redislocation rates were 13% (36) of 271 shoulders with a Bankart repair and 1% (1) of the 93 shoulders with a Latarjet repair.

Need for a Pilot Study Prior to a Large Trial:

No comparative randomized control trial has been completed evaluating Bankart repair in comparison to Latarjet procedure in the setting of mild to moderate bone loss. Thus, surgeons face uncertainty regarding which procedure to perform. The Latarjet is more invasive (larger incision) and some research suggests it may be more effective at treating instability. The Bankart procedure, while minimally invasive (smaller incision), may result in higher rates of instability after surgery.

Prior to a large trial, the investigators will conduct a pilot trial comparing arthroscopic capsuloligamentous repair (Bankart Procedure) vs. coracoid transfer (Latarjet procedure) on recurrent dislocation rates and functional outcomes over a 24-month period. This research will provide surgeons with new information regarding the best treatment for recurrent shoulder dislocation.

Study Aims and Objectives:

A pilot study is needed prior to a large trial to determine the feasibility of a larger trial in terms of:

1. Ability to recruit across clinical sites
2. Adherence to study protocol and,
3. Ability to follow participants for 24 months

The trial will also compare arthroscopic capsuloligamentous repair (Bankart + Remplissage Procedure) vs. coracoid transfer (Latarjet procedure) on:

1. Rates of recurrent shoulder dislocations and symptoms of instability up to 24 months' post- surgery;
2. Clinical outcomes measured by Western Ontario Shoulder Instability (WOSI) Index, American Shoulder and Elbow Society (ASES) score;
3. Physical examination: range of motion, strength, stability;
4. Return to previous level of activity;
5. Rate of shoulder-related complications and serious adverse events.

Study Design:

The investigators propose a multi-center pilot Randomized Clinical Trial of 82 patients across Canada, United States and Europe to compare the effect of capsuloligamentous repair (Bankart + Remplissage procedure) and coracoid transfer (Latarjet procedure) in patients with post-traumatic recurrent anterior dislocation. Eligible and consenting participants will be followed-up by the site for 24 months. Outcomes will be assessed at 2 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery. Eligible participants will be randomized to one of two treatment groups:

1. Arthroscopic capsuloligamentous repair (Bankart + Remplissage Procedure)
2. Open or Arthroscopic coracoid transfer (Latarjet Procedure)

Once participants have provided informed consent, baseline demographics, relevant medical history, and details regarding their diagnosis will be collected from the participant, the attending surgeon, their medical record and through physical examination. Participants will also complete The Western Ontario Shoulder Instability Index (WOSI) and he American Shoulder and Elbow Surgeons questionnaire (ASES) at the time of enrolment.

After surgery, surgical and peri-operative details will be collected from the attending surgeon and the participant's medical records. Adverse events occurring during the surgical procedure or perioperative period will also be documented.

Study Design

• 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, 2022
• Estimated Study Completion Date: January 1, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bankart + Remplissage 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 + Remplissage 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.

Outcome Measures

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

Eligibility Criteria

• 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.
• Pregnancy

Contacts and Locations

Contacts

Contact: Miriam Garrido Clua, MSc; 905-522-1155 ext 32953; garridom@mcmaster.ca

Contact: Moin Khan, MD; 905-522-1155 ext 32953; moinkhanmd@gmail.com

Locations

Canada, Ontario

St. Joseph's Healthcare Hamilton; Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contact: Kim Madden maddenk@mcmaster.ca

Principal Investigator: Moin Khan, MD, MSc,FRCSC

Sponsors and Collaborators

Moin Khan

St. Joseph's Healthcare Hamilton

University of Michigan

University of Western Ontario, Canada

The Ottawa Hospital

Pan Am Clinic

University of Colorado, Denver

Queen's University

Sunnybrook Health Sciences Centre

Boston University

Hospital Vall d'Hebron

Campus Bio-Medico University

OLVG

Deventer Ziekenhuis

Banff Sport Medicine Foundation

McMaster University

Brantford General Hospital

London Health Sciences Centre

Parc de Salut Mar

Hospital Universitari de Bellvitge

Hospital Universitario La Paz

Hospital de Terrassa

Hospital Dr Sotero del Rio

Investigators

• Principal Investigator: Moin Khan, MD; McMaster University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Khan M, Bedi A, Degen R, Warner J, Bhandari M; STABLE Investigators. A pilot multicenter randomized controlled trial comparing Bankart repair and remplissage with the Latarjet procedure in patients with subcritical bone loss (STABLE): study protocol. Pilot Feasibility Stud. 2022 Jan 31;8(1):20. doi: 10.1186/s40814-022-00987-4.

• Responsible Party: Moin Khan, MD, MSc, FRCSC, McMaster University
• ClinicalTrials.gov Identifier: NCT03585491
• Other Study ID Numbers: STABLE
• First Posted: July 13, 2018
• Last Update Posted: March 8, 2021
• Last Verified: March 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

Additional relevant MeSH terms:

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