Operative Treatment of Traumatic Anteroinferior Shoulder Instability in Young Male Patients. The Outcome of Arthroscopic Bankart vs. Open Latarjet Stabilization Surgery, a Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Turku University Hospital
- Enrollment
- 120
- Locations
- 8
- Primary Endpoint
- recurrence of instability
Study Overview
Brief Summary
Glenohumeral joint is prone to instability, i.e. the humeral head may dislocate off the scapular glenoid plate especially in the anteroinferior direction. Surgical treatment of shoulder instability aims at restoration of shoulder stability. The purpose of this trial is to investigate the difference in outcome after arthroscopic Bankart operation compared with open Latarjet operation in the treatment of a residual instability after a traumatic primary dislocation in young males.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 16 Years to 25 Years (Child, Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subluxation or fear of shoulder dislocation after a previous, reduced and primarily conservatively treated (for more than 3 months) traumatic anteroinferior shoulder dislocation, or redislocation after a primary shoulder dislocation.
- •Clinically documented anteroinferior instability (ie. a positive apprehension and relocation test (Jobe)).
- •X-ray (true ap, 30 degrees oblique ap, Y- and axillary projections), 2- and 3-dimensional computed tomography (2D and 3D CT) and magnetic resonance imaging arthrography (MRA) documentation of the joint.
- •Congruency of the shoulder joint on imaging investigations.
- •Young adult male patient 16-25 years of age (15 years < patient < 26 years ).
- •Patient's willingness for operative treatment.
- •Written informed consent from participating subject.
Exclusion Criteria
- •Non-congruency of the glenohumeral joint on imaging investigations.
- •Concomitant dislocated fractures (requiring operative treatment) of the humerus or the scapula (other than Hill-Sachs lesion or bony Bankart lesion)
- •Severe grade 2 or above (Samilson et Prieto) osteoarthrosis of the glenohumeral joint detected in X-ray investigation.
- •A humeral avulsion of glenohumeral ligaments (HAGL) detected in MRA investigation.
- •Concomitant ipsilateral plexus or axillar nerve injury affecting motor function.
- •Life threatening other concomitant injuries (i.e. multitrauma patient).
- •Stiffness of the glenohumeral joint (restricted passive external rotation less than 30 degrees measured in standing position, arm at side).
- •Age under 16 or above 25 years.
- •Open physis with significant growth expectation.
- •Intellectual disability, history of seizures with high risk of recurrence, existing significant malignant, haematological, endocrine, metabolic, or rheumatoid disease.
Arms & Interventions
Latarjet
60 patients treated with open Latarjet operation
Intervention: Latarjet (Procedure)
Bankart
60 patients treated with arthroscopic Bankart operation
Intervention: Bankart (Procedure)
Outcomes
Primary Outcomes
recurrence of instability
Time Frame: 5 years
The recurrence of instability (re-dislocation, subluxation, positive apprehension) is used as a primary outcome measure together with WOSI score two and five years postoperatively.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ville Aarimaa
adjunct professor
Turku University Hospital