Randomized Trial Evaluating First Time Shoulder Dislocation: Surgery vs Conservative Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- McMaster University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Recruitment Feasibility
Study Overview
Brief Summary
The primary objective of the pilot study is to assess the feasibility of a definitive trial to determine the effect of arthroscopic soft tissue stabilization vs. non-operative management on the risk of recurrent anterior dislocation rates and functional outcomes following in patients presenting with a first-time dislocation (FTD) over a 24-month period.
Detailed Description
Background
The shoulder is the most commonly dislocated joint in the body with a global incidence that ranges from 15 to 25 per 100 000 people. It is estimated that approximately 70 000 shoulder dislocations occur annually in the United States. In North America, a sampling of individuals presenting with shoulder dislocations to US emergency departments identified an overall incidence rate in the United States of 24 (95% confidence interval, 20.8 to 27.0) per 100,000 person-years and a maximum incidence rate (47.8 [95% confidence interval, 41.0 to 54.5]) occurring in those between the ages of twenty and twenty-nine years. A review of shoulder reductions performed in emergency rooms in Ontario, Canada between 2002 and 2010 identified 719 dislocations affecting primarily young patients with a median age of 35 years and 74% male. The incidence density rate of shoulder dislocations was found to be 23/100,000 person-years and highest among young males (98/100,000 person-years).
Recurrence mainly occurs in the first 2 years after the first anterior shoulder dislocation event, and recurrent instability significantly affects quality of life, sport, and professional activities.4 Epidemiologic data suggests that younger patients are at significantly higher the risk of recurrence. In a prospective study of 252 patients by Robinson et al, the recurrence rate after 5 years reached 86.6% in patients aged 15 to 20 years, 73.8% in patients between 21 and 25 years of age, and 46.8% in patients between 26 and 30 years of age. Participation in contact and overhead throwing sports and higher sporting levels also increases the risk of recurrence.
Management options in patients with a first-time shoulder dislocation include non-operative and operative approaches.
Anterior dislocations often injure the anterior and inferior glenoid labrum, described as the Bankart lesion. This lesion was observed arthroscopically in 94% to 100% of patients and often result in long-term instability. Thus, there is debate as to whether arthroscopic Bankart repair should be routinely performed in patients after a first-time anterior shoulder dislocation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 40 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients ages 14-40 years;
- •Diagnosis of first-time shoulder anterior dislocation having occurred within the past 3 months confirmed either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms;
- •Provision of informed consent.
Exclusion Criteria
- •Patients that cannot undergo surgery or anesthesia;
- •Patients with concomitant injuries (rotator cuff tear, fracture)
- •Previous shoulder surgery;
- •Patients that will likely have problems with maintaining follow-up or are incarcerated;
- •Epilepsy/seizure disorder;
- •Diagnosis of multidirectional instability;
- •Bony glenoid defect (bony Bankart) >10% as measured on preop imaging;
- •Dislocation without trauma, in a context of hyper laxity or atraumatic instability;
- •Cases involving litigation or workplace insurance claims (e.g., WSIB).
Arms & Interventions
Bankart repair + Remplissage (randomized cohort)
Arthroscopic repair of anterior capsulo-labral structures
Intervention: Bankart + Remplissage Procedure (Procedure)
Conservative treatment (randomized cohort)
Non surgical intervention
Bankart repair + Remplissage (non-randomized cohort)
Arthroscopic repair of anterior capsulo-labral structures
Intervention: Bankart + Remplissage Procedure (Procedure)
Conservative treatment (non-randomized cohort)
Non surgical intervention
Outcomes
Primary Outcomes
Recruitment Feasibility
Time Frame: 10 months
Number of patients recruited
Crossovers
Time Frame: 2 years
Assessment of crossovers between groups
Surgery within 3 months of enrollment
Time Frame: 3 months
Ability to operate on patients within 3 months following enrollment
Follow-up
Time Frame: 2 years
Proportion of participants followed at two years
Secondary Outcomes
- Clinical Outcome - shoulder activity(2 years)
- Rate of participants with risk of having recurrent shoulder instability(2 years)
- Clinical Outcome - pain(2 years)
- Clinical Outcome - shoulder function(2 years)
- Clinical Outcome - patient satisfaction(2 years)
- Range of motion(2 years)
- Rate of Instability(2 years)
- Rate of participants that return to previous level of activity(2 years)
- Return to work(2 years)
- Adverse events(2 years)
- Rate of Recurrence Dislocation(2 years)
- Clinical Outcome(2 years)
- Clinical Outcome - Quality of Life(2 years)
Investigators
Moin Khan
Associate Professor and Orthopaedic Surgeon
McMaster University