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RCT Evaluating First Time Shoulder Dislocation

Shoulder Dislocation | Sport Injury | Anterior Dislocation

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    14 to 40

Participation 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).

Study Location

St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Miriam Garrido Clua, MSc

[email protected]
Study Sponsored By
McMaster University
Participants Required
More Information
Study ID: NCT05715021