RCT Evaluating First Time Shoulder Dislocation
Launched by MCMASTER UNIVERSITY · Jan 27, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how to best treat patients who experience their first shoulder dislocation, which often happens during sports or physical activities. Researchers want to compare two approaches: one group will receive a surgical procedure called arthroscopic soft tissue stabilization to help prevent future dislocations, while the other group will follow a non-surgical management plan. The goal is to find out which method reduces the chances of the shoulder dislocating again and improves overall shoulder function over a period of two years.
To participate in this study, individuals must be between 14 and 40 years old and have had a first-time shoulder dislocation within the last three months. They will need to provide consent to join the trial. However, some people may not be eligible, such as those who cannot have surgery, have previous shoulder surgeries, or have certain other medical conditions. Participants in this trial can expect regular follow-up appointments to monitor their progress and help the researchers gather valuable information on the effectiveness of these treatment options.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Patients ages 14-40 years;
- • 2. 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;
- • 3. Provision of informed consent.
- Exclusion Criteria:
- • 1. Patients that cannot undergo surgery or anesthesia;
- • 2. Patients with concomitant injuries (rotator cuff tear, fracture)
- • 3. Previous shoulder surgery;
- • 4. Patients that will likely have problems with maintaining follow-up or are incarcerated;
- • 5. Epilepsy/seizure disorder;
- • 6. Pregnancy;
- • 7. Diagnosis of multidirectional instability;
- • 8. Bony glenoid defect (bony Bankart) \>10% as measured on preop imaging;
- • 9. Dislocation without trauma, in a context of hyper laxity or atraumatic instability;
- • 10. Cases involving litigation or workplace insurance claims (e.g., WSIB).
About Mcmaster University
McMaster University, a leading research institution located in Hamilton, Ontario, Canada, is renowned for its innovative approach to education and its commitment to advancing healthcare through rigorous clinical research. The university's diverse research programs are supported by a multidisciplinary team of experts dedicated to improving patient outcomes and public health. With a strong emphasis on evidence-based medicine, McMaster University actively engages in clinical trials that explore new therapies, interventions, and health technologies, fostering collaboration among researchers, healthcare professionals, and industry partners to translate findings into real-world applications.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hamilton, Ontario, Canada
Patients applied
Trial Officials
Moin Khan, MD
Principal Investigator
McMaster University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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