Recruiting

Observational Study

Sponsor:

McMaster University

Code:

NCT05715021

Conditions

Shoulder Dislocation

Sport Injury

Anterior Dislocation

Eligibility Criteria

Sex: All

Age: 14 - 40

Healthy Volunteers: Not accepted

Interventions

Bankart + Remplissage Procedure

Study Details

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.

Conditions

Shoulder Dislocation

Sport Injury

Anterior Dislocation

Study ID

NCT05715021

Start date

Jul 12, 2023

Status verified date

Sep, 2025

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 40

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bankart repair + Remplissage (randomized cohort)

Arthroscopic repair of anterior capsulo-labral structures

no intervention: Conservative treatment (randomized cohort)

Non surgical intervention

experimental: Bankart repair + Remplissage (non-randomized cohort)

Arthroscopic repair of anterior capsulo-labral structures

no intervention: Conservative treatment (non-randomized cohort)

Non surgical intervention

Interventions

Bankart + Remplissage Procedure

Participants will undergo arthroscopic stabilization.

Primary outcome measure

  • Recruitment Feasibility [ Time Frame: 10 months ]
  • Follow-up [ Time Frame: 2 years ]
  • Surgery within 3 months of enrollment [ Time Frame: 3 months ]
  • Crossovers [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Miriam Garrido Clua, MSc

mgarrido@stjoes.ca

More Information

Sponsor

McMaster University

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by McMaster University on 2025-09-26.