Clinical trial NCT01998048: Operative Treatment of Traumatic Anteroinferior Shoulder Instability in Young Male Patients
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Instability
Keywords: surgical treatment
Bankart
Latarjet
redislocation
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2013-11-28
Enrollment: 120
Sex: MALE
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Clinically documented anteroinferior instability (ie. a positive apprehension and relocation test (Jobe)).
3. 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.
4. Congruency of the shoulder joint on imaging investigations.
5. Young adult male patient 16-25 years of age (15 years \< patient \< 26 years ).
6. Patient's willingness for operative treatment.
7. Written informed consent from participating subject.

Exclusion Criteria:

1. Non-congruency of the glenohumeral joint on imaging investigations.
2. Concomitant dislocated fractures (requiring operative treatment) of the humerus or the scapula (other than Hill-Sachs lesion or bony Bankart lesion)
3. Severe grade 2 or above (Samilson et Prieto) osteoarthrosis of the glenohumeral joint detected in X-ray investigation.
4. A humeral avulsion of glenohumeral ligaments (HAGL) detected in MRA investigation.
5. Concomitant ipsilateral plexus or axillar nerve injury affecting motor function.
6. Life threatening other concomitant injuries (i.e. multitrauma patient).
7. Stiffness of the glenohumeral joint (restricted passive external rotation less than 30 degrees measured in standing position, arm at side).
8. Age under 16 or above 25 years.
9. Open physis with significant growth expectation.
10. Intellectual disability, history of seizures with high risk of recurrence, existing significant malignant, haematological, endocrine, metabolic, or rheumatoid disease.

Primary outcomes:
measure: recurrence of instability
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
measure: shoulder state
timeFrame: 5 years
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Jyväskylä
country: Finland
facility: Keski-Suomen keskussairaala
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Pori
country: Finland
facility: Satakunnan keskussairaala
city: Tampere
country: Finland
facility: Hatanpään sairaala
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Ville Äärimaa, Adjunct Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kukkonen J, Elamo S, Flinkkila T, Paloneva J, Mantysaari M, Joukainen A, Lehtinen J, Lepola V, Holstila M, Kauko T, Aarimaa V; FINNISH (Finnish Instability Shoulder Study) Investigators. Arthroscopic Bankart versus open Latarjet as a primary operative treatment for traumatic anteroinferior instability in young males: a randomised controlled trial with 2-year follow-up. Br J Sports Med. 2022 Mar;56(6):327-332. doi: 10.1136/bjsports-2021-104028. Epub 2021 Sep 22.