Clinical trial NCT03585491: Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation
Official title: Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Shoulder Dislocation
Sport Injuries
Shoulder
Anterior Dislocation
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
name: University of Western Ontario, Canada
name: The Ottawa Hospital
name: Pan Am Clinic
name: University of Colorado, Denver
name: Queen's University
name: Sunnybrook Health Sciences Centre
name: Boston University
name: Hospital Vall d'Hebron
name: Deventer Ziekenhuis
name: Banff Sport Medicine Foundation
name: McMaster University
name: Brantford General Hospital
name: London Health Sciences Centre
name: Parc de Salut Mar
name: Hospital Universitari de Bellvitge
name: Hospital de Terrassa
name: Hospital Mutua de Terrassa
name: Pontificia Universidad Catolica de Chile
name: Endeavor Health
name: Medstar Health Research Institute
First posted: 2018-07-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: 10 months
measure: Protocol Adherence
timeFrame: 2 years
measure: Follow-up
timeFrame: 2 years
Secondary outcomes:
measure: Rate of Recurrence
timeFrame: 2 years
measure: Clinical Outcome
timeFrame: 2 years
measure: Clinical Outcome
timeFrame: 2 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Moin Khan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.