NCT05715021 RCT Evaluating First Time Shoulder Dislocation
| NCT ID | NCT05715021 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McMaster University |
| Condition | Shoulder Dislocation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-07-12 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-07-12 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Moin Khan, MD
PRINCIPAL INVESTIGATOR
McMaster University
Frequently Asked Questions
Who can join the NCT05715021 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 40 Years, studying Shoulder Dislocation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05715021 currently recruiting?
Yes, NCT05715021 is actively recruiting participants. Contact the research team at ddagher@stjoes.ca for enrollment information.
Where is the NCT05715021 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT05715021 clinical trial?
NCT05715021 is sponsored by McMaster University. The principal investigator is Moin Khan, MD at McMaster University. The trial plans to enroll 100 participants.