Surgical Treatments for Shoulder Instability

N/A

Recruiting

Led By Ivan H Wong, MD

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured throughout the entire study, up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether arthroscopic Bankart repair or arthroscopic anatomic glenoid reconstruction is better at reducing recurrent shoulder dislocation and improving function. The feasibility objectives are to assess the ability to recruit patients and to follow patients to 24 months. Clinical objectives are to gather data on outcomes to power a future definitive trial.

Who is the study for?

This trial is for individuals with recurrent shoulder dislocations who have specific bone loss visible on imaging. It's not suitable for those with uncontrolled diabetes, pregnancy, severe illness, massive rotator cuff tears, certain levels of bone loss, posterior instability, shoulder paralysis, cancer, generalized laxity or previous surgery on the affected shoulder.

What is being tested?

The study compares two surgical methods: arthroscopic Bankart repair and anatomic glenoid reconstruction to see which is better at preventing dislocations over a 24-month period. This pilot trial will test how well the study can be done across multiple sites and if patients stick to the protocol.

What are the potential side effects?

Potential side effects from these surgeries may include pain at the surgery site, infection risk increase due to incisions made during surgery, limited range of motion temporarily post-surgery or complications related to anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured throughout the entire study, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured throughout the entire study, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured throughout the entire study, up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participant Adherence

Patient Follow-up

Subject Recruitment

Secondary study objectives

Elbow

Hand

Incidence of Recurrence

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Anatomic Glenoid ReconstructionExperimental Treatment1 Intervention

The surgical technique was the lateral decubitus all-arthroscopic anatomic glenoid reconstruction procedure for treatment of anterior shoulder instability as described by Wong et al. (2015). The procedure is done in a semi-lateral decubitus position that assists with optimal graft placement on the native glenoid. The investigators utilize the cannulated Bristow-Latarjet Instability Shoulder System (Depuy-Mitek, MA, USA). The surgical technique is identical to that of arthroscopic Bankart repair with one additional step. Prior to insertion of anchors, one additional medal portal is created for insertion of the bone graft. The distal tibia allograft is prepared; the cannulated guide is attached and advanced through the rotator interval and secured with two cannulated screws. Finally, the Bankart repair is performed above the graft. Surgical time and video of the operation will be recorded, and photographs will be taken documenting any bone loss.

Group II: Bankart RepairActive Control1 Intervention

Arthroscopic Bankart repair procedures will be performed according to each individual surgeon's usual technique. Procedures will be performed with the patient in the lateral or beach-chair position. Repairs for associated or conjoined superior labral anterior-to-posterior (SLAP) tears will be documented and performed at the surgeon's discretion. Labral detachments will be repaired with the use of suture-anchor fixation and arthroscopic tying techniques. Either two or three suture anchors will be used. Capsular redundancy will be addressed with arthroscopic suture plication at the surgeon's discretion. Surgeons will mobilize the capsulolabral tissue as deemed necessary. Surgical time and video of the operation will be recorded, and photographs will be taken documenting any bone loss.

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